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GENEREX BIOTECHNOLOGY CORP - Quarter Report: 2006 January (Form 10-Q)


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 10-Q

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

For the quarterly period ended January 31, 2006

o 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 of other jurisdiction of incorporation or organization)
 
(IRS Employer Identification No.)
 
 
33 HARBOUR SQUARE, SUITE 202
TORONTO, ONTARIO
CANADA M5J 2G2

(Address of principal executive offices)

416/364-2551

(Registrant's telephone number, including area code)
 
Not applicable

(Former name, former address and former fiscal year
if changed since last report)

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. xYes  oNo

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). o Yes x No

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

APPLICABLE ONLY TO CORPORATE ISSUERS
The number of outstanding shares of the registrant's common stock, par value $.001, was 88,974,933 as of March 6, 2006.
 
 


 
GENEREX BIOTECHNOLOGY CORPORATION

INDEX

PART I. FINANCIAL INFORMATION
 
   
Item 1.     Financial Statements.
1
   
  (Unaudited)
 
  Consolidated Balance Sheets -
 
  January 31, 2006 and July 31, 2005
1
   
  Consolidated Statements of Operations -- for the three and six month
 
  periods ended January 31, 2006 and 2005, and cumulative from
 
  November 2, 1995 to January 31, 2006
2
   
  Consolidated Statements of Cash Flows -- For the six month
 
  periods ended January 31, 2006 and 2005, and cumulative from
 
  November 2, 1995 to January 31, 2006
3
   
  Notes to Consolidated Financial Statements
4
   
Item 2.     Management's Discussion and Analysis of Financial
 
         Condition and Results of Operations
24
   
Item 3.     Quantitative and Qualitative Disclosures
 
  About Market Risk
53
   
Item 4.    Controls and Procedures
54
   
PART II: OTHER INFORMATION
 
   
Item 1.     Legal Proceedings
55
   
Item 2.     Unregistered Sales of Equity Securities and Use of Proceeds
55
   
Item 3.     Defaults Upon Senior Securities
55
   
Item 4.     Submission of Matters to a Vote of Security Holders
55
   
Item 5.     Other Information
55
   
Item 6.     Exhibits
56
   
Signatures 
63
 
 



PART I. FINANCIAL INFORMATION

Item 1. Financial Statements


GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES  
 
(A DEVELOPMENT STAGE COMPANY)  
 
CONSOLIDATED BALANCE SHEETS  
 
                
                
        
January 31,
 
July 31,
 
        
2006
 
2005
 
   ASSETS              
Current Assets:
              
Cash and cash equivalents
       
$
15,552,084
 
$
586,530
 
Restricted cash
         
156,434
   
204,734
 
Short-term investments
         
6,000,000
   
--
 
Other current assets
         
214,142
   
165,586
 
Deferred debt issuance costs
         
448,375
   
337,798
 
Total Current Assets 
         
22,371,035
   
1,294,648
 
                     
                     
Property and Equipment, Net
         
2,793,161
   
3,976,742
 
Assets Held for Investment, Net
         
3,610,875
   
2,371,749
 
Patents, Net
         
5,272,863
   
5,443,094
 
Due From Related Party
         
404,545
   
379,612
 
                     
TOTAL ASSETS 
       
$
34,452,479
 
$
13,465,845
 
                     
                     
LIABILITIES AND STOCKHOLDERS’ EQUITY 
                   
                     
Current Liabilities:
                   
Accounts payable and accrued expenses
       
$
4,436,926
 
$
2,410,846
 
Short-term advance
         
347,369
   
325,179
 
Current maturities of long-term debt
         
3,041,719
   
2,571,530
 
Convertible Debentures, Net of Debt Discount of $4,252,277 and
                   
$2,108,459 at January 31, 2006 and July 31, 2005, respectively
         
1,132,338
   
1,314,926
 
Total Current Liabilities 
         
8,958,352
   
6,622,481
 
                     
Long-Term Debt, Net
         
365,476
   
716,361
 
                     
Commitments and Contingencies
                   
                     
Stockholders’ Equity:
                   
Special Voting Rights Preferred stock, $.001 par value;
                   
authorized, issued and outstanding 1,000 shares at
                   
January 31, 2006 and July 31, 2005, respectively
         
1
   
1
 
Common stock, $.001 par value; authorized 150,000,000 shares at
                   
January 31, 2006 and July 31, 2005; 73,881,774 and 41,933,898
                   
shares issued and outstanding, respectively
         
73,883
   
41,935
 
Additional paid-in capital
         
168,269,852
   
126,044,326
 
Deficit accumulated during the development stage
         
(143,931,923
)
 
(120,528,108
)
Accumulated other comprehensive income
         
716,838
   
568,849
 
Total Stockholders’ Equity 
         
25,128,651
   
6,127,003
 
                     
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY 
       
$
34,452,479
 
$
13,465,845
 
 
The Notes to Consolidated Financial Statements are an integral part of these statements.
 
 
1

 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
    
(A DEVELOPMENT STAGE COMPANY)
    
CONSOLIDATED STATEMENTS OF OPERATIONS
    
                   
Cumulative From
 
                   
November 2, 1995
 
   
For the Three Months Ended
 
For the Six Months Ended
 
(Date of Inception)
 
   
January 31,
 
January 31,
 
to January 31, 
 
   
2006
 
2005
 
2006
 
2005
 
2006 
 
                        
Revenues
 
$
43,750
 
$
76,750
 
$
87,500
 
$
219,500
 
$
2,106,796
 
                                 
Operating Expenses:
                               
Research and development
   
1,317,115
   
2,181,835
   
1,993,494
   
5,576,965
   
56,911,939
 
Research and development -
                               
related party
   
--
   
--
   
--
   
--
   
220,218
 
General and administrative
   
3,910,887
   
3,450,556
   
5,385,743
   
6,872,791
   
70,836,857
 
General and administrative -
                               
related party
   
--
   
--
   
--
   
--
   
314,328
 
Total Operating Expenses 
   
5,228,002
   
5,632,391
   
7,379,237
   
12,449,756
   
128,283,342
 
                                 
Operating Loss
   
(5,184,252
)
 
(5,555,641
)
 
(7,291,737
)
 
(12,230,256
)
 
(126,176,546
)
                                 
Other Income (Expense):
                               
Miscellaneous income (expense)
   
500
   
--
   
500
   
--
   
196,193
 
Income from Rental Operations, net
   
30,987
   
27,723
   
35,840
   
74,789
   
240,516
 
Interest income
   
14,759
   
338
   
16,096
   
18,776
   
3,410,576
 
Interest expense
   
(8,490,956
)
 
(773,602
)
 
(15,230,531
)
 
(819,516
)
 
(20,065,466
)
Loss on extinguishment of debt
   
(771,635
)
 
--
   
(933,983
)
 
--
   
(2,280,324
)
                                 
Net Loss Before Undernoted
   
(14,400,597
)
 
(6,301,182
)
 
(23,403,815
)
 
(12,956,207
)
 
(144,675,051
)
                                 
Minority Interest Share of Loss
   
--
   
--
   
--
   
--
   
3,038,185
 
                                 
Net Loss
   
(14,400,597
)
 
(6,301,182
)
 
(23,403,815
)
 
(12,956,207
)
 
(141,636,866
)
                                 
Preferred Stock Dividend
   
--
   
--
   
--
   
--
   
2,295,057
 
                                 
Net Loss Available to Common
                               
Shareholders
 
$
(14,400,597
)
$
(6,301,182
)
$
(23,403,815
)
$
(12,956,207
)
$
(143,931,923
)
                                 
Basic and Diluted Net Loss Per
                               
Common Share
 
$
(.23
)
$
(.18
)
$
(.43
)
$
(.37
)
     
                                 
Weighted Average Number of Shares
                               
of Common Stock Outstanding
   
63,906,552
   
35,108,460
   
54,852,364
   
34,958,009
       
 
The Notes to Consolidated Financial Statements are an integral part of these statements.
 
 
2

 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
    
(A DEVELOPMENT STAGE COMPANY)
    
CONSOLIDATED STATEMENTS OF CASH FLOWS
    
                
           
Cumulative From 
 
           
November 2, 1995 
 
   
For the Six Months Ended
 
(Date of Inception) 
 
   
January 31,
 
to January 31, 
 
   
2006
 
2005
 
2005 
 
Cash Flows From Operating Activities:
              
Net loss
 
$
(23,403,815
)
$
(12,956,210
)
$
(141,636,866
)
Adjustments to reconcile net loss to net cash used
                   
in operating activities:
                   
Depreciation and amortization
   
566,445
   
550,521
   
4,147,625
 
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
   
391,103
 
Write-off of deferred offering costs
   
--
   
--
   
3,406,196
 
Write-off of abandoned patents
   
1,278
   
--
   
77,364
 
Loss on extinguishment of debt
   
933,983
   
--
   
2,280,324
 
Common stock issued for services rendered
   
54,071
   
755,180
   
4,840,335
 
Amortization of prepaid services in conjunction with common stock issuance
   
92,250
   
--
   
92,250
 
Non-cash compensation expense
   
--
   
--
   
45,390
 
Stock options and warrants issued for services rendered
   
7,300,145
   
490,600
   
14,134,018
 
Preferred stock issued for services rendered
   
--
   
--
   
100
 
Treasury stock redeemed for non-performance of services
   
--
   
(138,000
)
 
(138,000
)
Amortization of deferred debt issuance costs and loan origination fees
   
777,967
   
77,994
   
1,026,074
 
Amortization of discount on convertible debentures
   
6,943,339
   
687,890
   
10,678,150
 
Common stock issued as interest payment on convertible debentures
   
112,688
   
--
   
189,684
 
Interest on short-term advance
   
13,524
   
--
   
22,190
 
Founders’ shares transferred for services rendered
   
--
   
--
   
353,506
 
Fees in connection with short-term refinancing of long-term debt
   
--
   
--
   
105,300
 
Changes in operating assets and liabilities (excluding the effects of acquisition):
                   
Miscellaneous receivables
   
--
   
--
   
43,812
 
Other current assets
   
49,118
   
704,564
   
(63,123
)
Accounts payable and accrued expenses
   
2,097,117
   
2,620,395
   
7,962,868
 
Other, net
   
--
   
--
   
110,317
 
 Net Cash Used in Operating Activities
   
(4,461,890
)
 
(6,815,963
)
 
(94,545,686
)
                     
Cash Flows From Investing Activities:
                   
Purchase of property and equipment
   
(76,665
)
 
(61,939
)
 
(4,369,381
)
Costs incurred for patents
   
(16,959
)
 
(139,039
)
 
(1,511,945
)
Change in restricted cash
   
60,721
   
(4,885
)
 
(110,275
)
Proceeds from maturity of short term investments
   
--
   
--
   
126,687,046
 
Purchases of short-term investments
   
(6,000,000
)
 
--
   
(132,687,046
)
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
   
--
   
395,889
   
(477,194
)
Change in notes receivable - common stock
   
--
   
(6,300
)
 
(91,103
)
Change in due from related parties
   
--
   
--
   
(2,222,390
)
Other, net
   
--
   
--
   
89,683
 
 Net Cash Provided by (Used in) Investing Activities
   
(6,032,903
)
 
183,726
   
(15,768,530
)
                     
Cash Flows From Financing Activities:
                   
Proceeds from short-term advance
   
--
   
--
   
325,179
 
Proceeds from issuance of long-term debt
   
--
   
--
   
1,970,148
 
Repayment of long-term debt
   
(107,352
)
 
(39,770
)
 
(1,314,290
)
Change in due to related parties
   
--
   
--
   
154,541
 
Proceeds from exercise of warrants
   
15,399,998
   
--
   
19,952,982
 
Proceeds from exercise of stock options
   
202,790
   
--
   
1,213,230
 
Proceeds from minority interest investment
   
--
   
--
   
3,038,185
 
Proceeds from issuance of preferred stock
   
--
   
--
   
12,015,000
 
Proceeds from issuance of convertible debentures, net
   
9,955,000
   
3,699,930
   
16,254,930
 
Repayments of convertible debentures
   
--
   
--
   
(461,358
)
Purchase of treasury stock
   
--
   
--
   
(483,869
)
Proceeds from issuance of common stock, net
   
--
   
--
   
73,283,715
 
Purchase and retirement of common stock
   
--
   
--
   
(119,066
)
 Net Cash Provided by (Used in) Financing Activities
   
25,450,436
   
3,660,160
   
125,829,327
 
                     
Effect of Exchange Rates on Cash
   
9,911
   
13,826
   
36,973
 
                     
Net Increase (Decrease) in Cash and Cash Equivalents
   
14,965,554
   
(2,958,251
)
 
15,552,084
 
                     
Cash and Cash Equivalents, Beginning of Period
   
586,530
   
4,950,419
   
--
 
                     
Cash and Cash Equivalents, End of Period
 
$
15,552,084
 
$
1,992,168
 
$
15,552,084
 
 
The Notes to Consolidated Financial Statements are an integral part of these statements.
 
 
3

 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

1.  
Basis of Presentation
The accompanying unaudited interim consolidated financial 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 financial statements and notes thereto included in the Company’s latest Annual Report on Form 10-K. The results for the three and six months 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 the fiscal year 2006. 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 accompanying financial 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 had an accumulated deficit at January 31, 2006 of approximately $144 million. The Company has funded its activities to date almost exclusively from debt and equity financings.

The Company is in the development stage and has realized minimal revenues to date. The Company will continue to require substantial funds to continue research and development, including preclinical studies and clinical trials of its product candidates, and to commence sales and marketing efforts if the FDA or other regulatory approvals are obtained. Management’s plans in order to meet its operating cash flow requirements include financing activities such as private placement of its common stock, preferred stock offerings and offerings of debt and convertible debt instruments. Management is also actively pursuing industry collaboration activities including product licensing and specific project financing.

While the Company believes that it will be successful in obtaining the necessary financing to fund its operations, there are no assurances that such additional funding will be achieved and that it will succeed in its future operations. The financial 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.

2.  
Effects of Recent Accounting Pronouncements
In December 2004, the FASB issued Statement of Financial Accounting Standards No. 123(R), "Share-Based Payment" ("SFAS 123(R)"), which requires all companies to measure compensation cost for all share-based payments (including employee stock options) at fair value and to recognize cost over the vesting period. In March 2005, the SEC released SEC Staff Accounting Bulletin No. 107, "Share-Based Payment" ("SAB 107"). SAB 107 provides the SEC staff position regarding the application of SFAS 123(R), including interpretive guidance related to the interaction between SFAS 123(R) and certain SEC rules and regulations, and provides the staff's views regarding the valuation of share-based payment arrangements for public companies. SAB 107 highlights the importance of disclosures made related to the accounting for share-based payment transactions. In April 2005, the SEC announced that companies may implement SFAS 123(R) at the beginning of their next fiscal year beginning after June 15, 2005, or December 15, 2005 for small business issuers. The Company implemented the provisions of SFAS 123(R) and SAB 107 in the first quarter of fiscal 2006 using the modified-prospective method, and it did not have a material impact on our financial position or cash flows. See Note 3 - "Stock Based Compensation" for further information and the required disclosures under SFAS 123(R) and SAB 107, including the impact of the implementation on our results of operations.
 
4

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

2.  
Effects of Recent Accounting Pronouncements (Continued)
In December 2004, the FASB issued SFAS No. 153, "Exchanges of Nonmonetary Assets - an amendment of APB Opinion No. 29." The statement addresses the measurement of exchanges of nonmonetary assets and eliminates the exception from fair value measurement for nonmonetary exchanges of similar productive assets and replaces it with an exception for exchanges that do not have commercial substance. SFAS No. 153 is effective for nonmonetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. This adoption of this statement did not have a significant impact on the consolidated results of operations or financial position of the Company.

In May 2005, the FASB issued SFAS No. 154, “Accounting Changes and Error Corrections.” This statement replaces APB No. 20 and SFAS No. 3 and changes the requirements for the accounting and reporting of a change in accounting principle. APB No. 20 previously required that most voluntary changes in accounting principle be recognized by including in net income of the period of the change the cumulative effect of changing to the accounting principle. SFAS No. 154 requires retrospective application to prior periods’ financial statements of voluntary changes in accounting principle. SFAS No. 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005. The Company does not expect that the adoption of SFAS No. 154 will have a significant impact on the consolidated results of operations or financial position of the Company.

In February 2006, the FASB issued SFAS No. 155,”Accounting for Certain Hybrid Financial Instruments - an amendment of FASB Statements No. 133 and 140,” to simplify and make more consistent the accounting for certain financial instruments. Specifically, SFAS No. 155 amends SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, to permit fair value remeasurement for any hybrid financial instrument with an embedded derivative that otherwise would require bifurcation, provided that the whole instrument is accounted for on a fair value basis. SFAS No. 155 amends SFAS No. 140, Accounting for the Impairment or Disposal of Long-Lived Assets, to allow a qualifying special-purpose entity (SPE) to hold a derivative financial instrument that pertains to a beneficial interest other than another derivative financial instrument. SFAS No. 155 applies to all financial instruments acquired or issued after the beginning of an entity’s first fiscal year that begins after September 15, 2006, with earlier application allowed. The Company does not expect that the adoption of SFAS No. 155 will have a significant impact on the consolidated results of operations or financial position of the Company.

3.  
Stock-Based Compensation
As of January 31, 2006, the Company had two stockholder-approved stock incentive plans under which options exercisable for shares of common stock have been or may be granted to employees, directors, consultants and advisors. A total of 2,000,000 shares of common stock are reserved for issuance under the 2000 Stock Option Plan (the 2000 Plan) and a total of 12,000,000 shares of common stock are reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan). There were 1,690,000 and 457,981 shares of common stock reserved for future awards under the 2000 Plan and 2001 Plan, respectively, as of January 31, 2006.

The 2000 and 2001 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.

 
5

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

3.  
Stock-Based Compensation (Continued)
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 are Non-Qualified Options.

Prior to August 1, 2005, the Company accounted for the share-based compensation granted under its stock incentive plans under the recognition and measurement provisions of Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," and related interpretations ("APB 25"). In accordance with APB 25, the Company used the intrinsic-value method of accounting for stock option awards to employees and accordingly did not recognize compensation expense for its stock option awards to employees in its Consolidated Statement of Operations prior to August 1, 2005, as all option exercise prices were equal to the fair market value of the Company stock on the date the options were granted. Effective August 1, 2005, the Company implemented the fair value recognition provisions of Financial Accounting Standards Board (FASB) Statement No. 123 (revised 2004) ("SFAS 123 (R)"), "Share Based Payment," which is a revision of SFAS No. 123, "Accounting for Stock Based Compensation," and SAB 107 for all share-based compensation that was not vested as of July 31, 2005.

For the three and six months ended January 31, 2006, no compensation expense was recorded for options outstanding as of August 1, 2005. There were no options granted during the three and six months ended January 31, 2006.
 
The following table illustrates the pro forma effect on net income and earnings per share for the three and six months ended January 31, 2005, assuming the Company had applied the fair value recognition provisions of SFAS 123(R) to all previously granted share-based awards after giving consideration to potential forfeitures during such periods. The fair value of each option grant is estimated at the grant date using the Black-Scholes option-pricing model based on the assumptions listed below. The estimated fair value of options granted is expensed at the date of grant. Share-based employee compensation for the three and six months ended January 31, 2006 in the amount of $-0- (net of related tax), is included in the net loss of $14,091,721 and $23,094,939, respectively. The following table represents the impact had the treatment been adopted at August 1, 2004.
 
   
Six Months
 
Three Months
 
   
Ended
 
Ended
 
   
January 31,
 
January 31,
 
   
2005
 
2005
 
Net Loss Available to Common Stockholders,
         
as Reported
  $ (12,956,210 ) $ (6,298,182 )
               
Add: Total Stock-Based Employee Compensation
             
Included in Reported Net Loss
   
--
   
--
 
               
Deduct: Total Stock-Based Employee Compensation
             
Income Determined Under Fair Value Based Method,
             
Net of Related Tax Effect
   
1,430,640
   
--
 
               
Pro Forma Net Loss Available to Common Stockholders
 
$
(14,386,850
)
$  (6,298,182 )
 
 
6

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

3.  
Stock-Based Compensation (Continued)
 
   
 Six Months 
 
 Three Months
 
   
 Ended
 
 Ended
 
   
 January 31,
 
January 31,
 
   
2005
 
 2005
 
Loss Per Share:
         
Basic and diluted, as reported 
  $ (0.37 ) $ (0.18 )
Basic and diluted, pro forma 
  $ (0.41 ) $ (0.18 )
 
The implementation of the provisions of SFAS 123(R) and SAB 107 during the three and six months ended January 31, 2006 did not have a material impact on the Company’s cash flow from operations or cash flow from financing activities.

The following information relates to stock options that have been granted under the Company’s stockholder-approved incentive plans. The stock option exercise price is typically granted at 100 percent of the fair market value on the date the options are granted. Options may be exercised for a period of five years commencing on the date of grant and vesting over two years from the date of grant.

The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model. No options were granted to employees during the three and six months ended January 31, 2006.

The summary of the stock option activity for the six months ended January 31, 2006 is as follows:
 

 
       
 Weighted
 
 Weighted
 
       
 Average
 
 Average
 
       
 Exercise 
 
Remaining
 
       
 Price
 
 Contractual
 
   
Shares
 
 Share
 
 Term (Years)
 
               
Outstanding, August 1, 2005      11,607,269   $ 1.51     3.65  
Granted     --   $ --     --  
Cancelled     (140,000 ) $ 8.41     --  
Exercised     (253,000 ) $ 0.80     --  
Outstanding, January 31, 2006      11,214,269   $ 1.43     3.41  
 
The summary of the status of the Company’s non-vested as of January 31, 2006, as changes during the six months then ended is as follows:
 
       
 Weighted 
 
       
 Average 
 
       
 Grant Date 
 
   
 Shares
 
 Fair Value
 
           
Non-vested Stock Options, August 1, 2005     628,000   $ 0.72  
Granted     --   $ --  
Cancelled     --   $ --  
Vested     (620,500 ) $ 0.72  
Exercised     (7,500 ) $ 0.72  
Non-vested Stock Options, January 31, 2006       --   $ --  
 
 
7


 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

3.  
Stock-Based Compensation (Continued)
As of January 31, 2006, there was no unrecognized compensation related to non-vested stock options granted under the Company’s stock option plans.

4.  
Comprehensive Income/(Loss)
Comprehensive loss, which includes net loss and the change in the foreign currency translation account during the period, for the three months ended January 31, 2006 and 2005, was $14,341,265 and $6,363,814, respectively and for the six months ended January 31, 2006 and 2005 was $23,255,826 and $12,702,918, respectively.

5.  
Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consist of the following:
 
   
 January 31, 
 
 July 31, 
 
   
 2006
 
  2005 
 
           
Accounts Payable    $ 1,346,246  
$
999,726
 
Accounting and Auditing       250,187     274,627  
Accrued Legal Fees and Settlement       517,320    
599,461
 
Termination Agreements and Severance Pay       283,173    
265,720
 
Executive Compensation and Directors Fees       2,040,000     271,312  
Total 
  $ 4,436,926   $ 2,410,846  
  
6.  
Convertible Debentures

$4 Million Convertible Debenture
On November 8, 2004, the Company entered into four definitive agreements with four accredited investors, pursuant to which the Company would issue four $1,000,000 convertible promissory notes (“convertible debentures”) for aggregate gross proceeds of $4,000,000. The notes carry a 6% coupon and a 15-month term and amortize in 13 equal monthly installments commencing in the third month of the term. The convertible debentures are convertible into registered common stock of the Company at $0.82 per share. The principal and interest payments are payable in cash or, at the Company's option, the lesser of registered stock valued at a 10% discount to the average of the 20-day VWAP as of the payment date or $0.82, subject to certain restrictions. The transaction terms include 100% five-year warrant coverage at a per share exercise price equal to a 10% premium to the 10-day VWAP on the closing date and a 100% additional investment right exercisable for up to twelve months following the effective date of the registration statement in respect of the transaction.

During December 2004, the Company issued the aforementioned convertible debentures. Proceeds related to the issuance, net of issuance costs of $389,970, amounted to $3,699,930. Included in the issuance costs were warrants issued to a third party to purchase 145,000 shares of common stock at $0.91 per share. The fair value of the warrant was determined to be $89,900 using the Black Scholes pricing model assuming a risk-free rate of 1.79 percent, an expected volatility of 1.0463 and a five year life. The fair value of the warrant, which has been allocated to additional paid in capital, and together with the $300,070 of issuance costs is being amortized over the life of the debt as a deferred debt issuance cost. During the six months ended January 31, 2006, $155,988 has been amortized as interest expense and the remaining unamortized balance of $-0- is included in deferred debt issuance costs.


8

 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

$4 Million Convertible Debenture (Continued)
The holders of the convertible debentures also received warrants to purchase 4,878,048 of common stock at $0.91 per share. In accordance with Emerging Issues Task Force Issue 00-27, Application of Issue No. 98-5 to Certain Convertible Instruments ("EITF 00-27"), the Company recognized the value attributable to the warrants in the amount of $1,722,222 to additional paid-in capital and a discount against the convertible debenture. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 1.79 percent, an expected volatility of 1.0463 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible debenture’s maturity period as interest expense using the effective yield method.

In accordance with Emerging Issues Task Force Issue 98-5, Accounting for Convertible Securities with a Beneficial Conversion Features or Contingently Adjustable Conversion Ratios ("EITF 98-5"), the Company recognized the value attributable to the beneficial conversion feature, valued at $1,722,222, to additional paid-in capital and a discount against the convertible debenture. The debt discount attributed to the beneficial conversion feature is amortized over the convertible debenture's maturity period as interest expense using the effective yield method.

The Company amortized the convertible debenture debt discount attributed to the beneficial conversion feature and the value of the warrants and recorded non-cash interest expense of $630,451 during the six months ended January 31, 2006. During the six months ended January 31, 2006, the Company has issued 646,834 shares of common stock to the holders of the convertible debentures upon receipt of the holders’ notice of conversion of principal and interest totaling $530,403. This conversion resulted in a charge of $42,409 to loss on extinguishment of debt that represents the difference between quoted market price of the Company’s common stock and 10 percent discount to the average of the 20-day VWAP.

The Company has repaid the note holders $693,671 of the principal and interest in 1,169,613 shares of common stock during the six months ended January 31, 2006. This repayment resulted in a charge of $147,457 to loss on extinguishment of debt that represents the difference between quoted market price of the Company’s common stock and 10 percent discount to the average of the 20-day VWAP.

$500,000 Convertible Debenture
On March 28, 2005, the Company entered into a definitive agreement pursuant to which the Company would issue a convertible promissory note for aggregate gross proceeds of $500,000. The note bore interest at 10 percent per annum payable in common stock at the holders option and was due on May 15, 2005. The note was convertible into registered common stock of the Company at a per share price equal $0.82.

The holder of the convertible debenture also received warrants to purchase 1,219,512 of common stock at $0.82 per share. In accordance with EITF 00-27 the Company recognized the value attributable to the warrants, in the amount of $245,521, to additional paid-in capital and a discount against the convertible debenture. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 2.78 percent, an expected volatility of 1.0054 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible note’s maturity period as interest expense using the effective yield method.

 
9

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

$500,000 Convertible Debenture (Continued)
In accordance with EITF 98-5, the Company recognized the value attributable to the beneficial conversion feature valued at $86,984, to additional paid-in capital and a discount against the convertible note. The debt discount attributed to the beneficial conversion feature is amortized over the convertible note's maturity period as interest expense using the effective yield method.

The Company fully amortized the convertible note debt discount attributed to the beneficial conversion feature and the value of the warrants and recorded non-cash interest expense of $332,505 during the year ended July 31, 2005.

On June 7, 2005 the Company entered into an agreement with the note holder to extend the maturity date of the convertible note to July 22, 2005. In consideration for the holder’s agreement to amend the original convertible note the Company granted a warrant to purchase 1,219,512 shares of common stock at $0.82 per share with an expiration of June 10, 2010. In accordance with EITF 98-5 the fair value of the warrants, $597,561, was determined to be the reacquisition price on the debt on the extinguishment date and was recorded as a loss on extinguishment of the debt. It was then determined that the new debt did not have a beneficial conversion feature.

On July 22, 2005 the Company entered into an agreement with the note holder to extend the maturity date of the convertible note to September 20, 2005. In consideration for the holder’s agreement to amend the original convertible note the Company granted a warrant to purchase 1,219,512 shares of common stock at $0.82 per share with an expiration of July 22, 2010. In accordance with EITF 98-5 the fair value of the warrants, $524,390, was determined to be the reacquisition price on the debt on the extinguishment date and was recorded as a loss on extinguishment of the debt. It was then determined that the new debt did not have a beneficial conversion feature.

During the six months ended January 31, 2006, the Company issued 644,003 shares of common stock to the holder of the convertible note upon receipt of the holder’s notice of conversion of principal and interest totaling $528,082.

$100,000 Convertible Debenture
On April 4, 2005, the Company entered into a definitive agreement pursuant to which the Company would issue a convertible promissory note for aggregate gross proceeds of $100,000. The note bore interest at 10 percent per annum payable in common stock at the holders option and was due on May 15, 2005. The note was convertible into registered common stock of the Company at a per share price equal $0.82.

The holder of the convertible note also received warrants to purchase 243,902 of common stock at $0.82 per share. In accordance with EITF 00-27, the Company recognized the value attributable to the warrants in the amount of $49,104 to additional paid-in capital and a discount against the convertible note. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 2.78 percent, an expected volatility of 1.0054 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible note’s maturity period as interest expense using the effective yield method.
 
 
10

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

$100,000 Convertible Debenture (Continued)
In accordance with EITF 98-5, the Company recognized the value attributable to the beneficial conversion feature valued at $17,397, to additional paid-in capital and a discount against the convertible note. The debt discount attributed to the beneficial conversion feature is amortized over the convertible note's maturity period as interest expense using the effective yield method.

The Company fully amortized the convertible note debt discount attributed to the beneficial conversion feature and the value of the warrants and recorded non-cash interest expense of $66,501 during the year ended July 31, 2005.

On June 7, 2005 the Company entered into an agreement with the note holder to extend the maturity date of the convertible note to July 22, 2005. In consideration for the holder’s agreement to amend the original convertible note the Company granted a warrant to purchase 243,902 shares of common stock at $0.82 per share with an expiration of June 10, 2010. In accordance with EITF 98-5 the fair value of the warrants, $119,512 was determined to be the reacquisition price on the debt on the extinguishment date and was recorded as a loss on extinguishment of the debt. It was then determined that the new debt did not have a beneficial conversion feature.

On July 22, 2005 the Company entered into an agreement with the note holder to extend the maturity date of the convertible note to September 20, 2005. In consideration for the holder’s agreement to amend the original convertible note the Company granted a warrant to purchase 243,902 shares of common stock at $0.82 per share with an expiration of July 22, 2010. In accordance with EITF 98-5 the fair value of the warrants, $104,878 was determined to be the reacquisition price on the debt on the extinguishment date and was recorded as a loss on extinguishment of the debt. It was then determined that the new debt did not have a beneficial conversion feature.

During the six months ended January 31, 2006, the Company issued 128,834 shares of common stock to the holders of the convertible note upon receipt of the holder’s notice of conversion of principal and interest totaling $105,644.

$2 Million Convertible Debenture
On June 17, 2005, the holders of the $4 million convertible debenture exercised 50 percent of their additional investment right “AIR Exercise” resulting in four $500,000 convertible promissory notes (“convertible debentures’) for an aggregate proceeds of $2,000,000. The notes carry a 6% coupon and a 15-month term and amortize in 13 equal monthly installments commencing in the third month of the term. The convertible debentures are convertible into registered common stock of the Company at $0.82 per share. The principal and interest payments are payable in cash or, at the Company's option, the lesser of registered stock valued at a 10% discount to the average of the 20-day VWAP as of the payment date or $0.82, subject to certain restrictions. The transaction terms include 100% five-year warrant coverage at a per share exercise price equal to a 10% premium to the 10-day VWAP on the closing date and a 100% additional investment right exercisable for up to twelve months following the effective date of the registration statement in respect of the transaction. In consideration of the AIR Exercise the Company reduced the conversion price of the convertible debentures issuable upon the AIR Exercise from $0.82 to $0.60 per share.
 
 
11

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

$2 Million Convertible Debenture (Continued)
Proceeds related to the AIR Exercise, net of issuance costs of $160,300, amounted to $1,839,700. Included in the issuance costs were warrants to purchase 35,000 shares of common stock at $0.82 per share and 170,732 shares of common stock valued at $0.82 per share issued to a third party. The fair value of the warrant was determined to be $20,300 using the Black Scholes pricing model assuming a risk-free rate of 3.02 percent, an expected volatility of 0.9775 and a five year life. The fair value of the warrant, which has been allocated to additional paid in capital, together with the $140,000 of issuance costs is being amortized over the life of the debt as a deferred debt issuance cost. During the six months ended January 31, 3006, the Company has amortized the remaining balance of deferred debt issuance costs in the amount of $124,103 as non-cash interest expense resulting from the convertible debenture being fully repaid.
 
The holders of the convertible debentures also received warrants to purchase 2,439,024 shares of common stock at $0.82 per share. In accordance with EITF 00-27, the Company recognized the value attributable to the warrants in the amount of $828,571 to additional paid-in capital and a discount against the convertible debenture. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 3.02 percent, an expected volatility of 0.9775 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible debenture’s maturity period as interest expense using the effective yield method.

In accordance with EITF 98-5 the Company recognized the value attributable to the beneficial conversion feature valued at $1,171,429, to additional paid-in capital and a discount against the convertible debenture. The debt discount attributed to the beneficial conversion feature is amortized over the convertible debenture's maturity period as interest expense using the effective yield method.

The Company amortized the convertible debenture debt discount attributed to the beneficial conversion feature and the value of the warrants and recorded non-cash interest expense of $62,316 for the six months ended January 31, 2006. During the six months ended January 31, 2006, the Company has issued 2,363,352 shares of common stock to the holders of the convertible debentures upon receipt of the holders’ notice of conversions of principal and interest totaling $1,418,011.

The Company has repaid the note holders $225,322 of the principal and interest in 407,075 shares of common stock during the six months ended January 31, 2006. This repayment resulted in a charge of $62,242 to loss on extinguishment of debt that represents the difference between quoted market price of the Company’s common stock and 10 percent discount to the average of the 20-day VWAP.
 
 
12


 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

Second $2 Million Convertible Debenture
On September 8, 2005, the holders of the $2 million convertible debenture exercised their additional investment right “AIR Exercise” resulting in four $500,000 convertible promissory notes (“convertible debentures’) for an aggregate proceeds of $2,000,000. The notes carry a 6% coupon and a 15-month term and amortize in 13 equal monthly installments commencing in the third month of the term. The convertible debentures are convertible into registered common stock of the Company at $0.82 per share. The principal and interest payments are payable in cash or, at the Company's option, the lesser of registered stock valued at a 10% discount to the average of the 20-day VWAP as of the payment date or $0.82, subject to certain restrictions. The transaction terms include 100% five-year warrant coverage at a per share exercise price equal to a 10% premium to the 10-day VWAP on the closing date and a 100% additional investment right exercisable for up to twelve months following the effective date of the registration statement in respect of the transaction. In consideration of the AIR Exercise the Company reduced the conversion price of the convertible debentures issuable upon the AIR Exercise from $0.82 to $0.60 per share.

Proceeds related to the AIR Exercise, net of issuance costs of $185,600, amounted to $1,814,400. Included in the issuance costs were warrants to purchase 60,000 shares of common stock at $0.82 per share and 170,732 shares of common stock valued at $0.82 per share issued to a third party. The fair value of the warrant was determined to be $30,600 using the Black Scholes pricing model assuming a risk-free rate of 3.76 percent, an expected volatility of 0.9232 and a five year life. The fair value of the warrant, which has been allocated to additional paid in capital, together with the $140,000 of issuance costs associated with the shares of common stock issued and $15,000 of legal costs are being amortized over the life of the debt as a deferred debt issuance cost. During the six months ended January 31, 2006, $172,130 has been amortized as interest expense and the remaining unamortized balance of $13,470 is included in deferred debt issuance costs.

The holders of the convertible debentures also received warrants to purchase 2,439,024 shares of common stock at $0.82 per share. In accordance with EITF 00-27, the Company recognized the value attributable to the warrants in the amount of $785,185 to additional paid-in capital and a discount against the convertible debenture. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 3.76 percent, an expected volatility of 0.9232 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible debenture’s maturity period as interest expense using the effective yield method.

In accordance with EITF 98-5 the Company recognized the value attributable to the beneficial conversion feature valued at $1,185,185, to additional paid-in capital and a discount against the convertible debenture. The debt discount attributed to the beneficial conversion feature is amortized over the convertible debenture's maturity period as interest expense using the effective yield method.

The Company amortized the convertible debenture debt discount attributed to the beneficial conversion feature and the value of the warrants and recorded non-cash interest expense of $1,634,884 for the six months ended January 31, 2006. During the six months ended January 31, 2006, the Company has issued 2,365,490 shares of common stock to the holders of the convertible debentures upon receipt of the holders’ notice of conversions of principal and interest totaling $1,421,249. This conversion resulted in a charge of $47,157 to loss on extinguishment of debt that represents the difference between quoted market price of the Company’s common stock and 10 percent discount to the average of the 20-day VWAP.
 
 
13


 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

Second $2 Million Convertible Debenture (Continued)
The Company has repaid the note holders $172,739 of the principal and interest in 287,899 shares of common stock during the six months ended January 31, 2006. This repayment resulted in a charge of $96,627 to loss on extinguishment of debt that represents the difference between quoted market price of the Company’s common stock and 10 percent discount to the average of the 20-day VWAP.

Second $500,000 Convertible Debenture
On October 27, 2005, one of the debenture holders exercised its additional investment right “AIR Exercise” resulting in a $500,000 convertible promissory note (“convertible debenture’) for an aggregate proceeds of $500,000. The convertible debenture carries a 6% coupon and a 15-month term and amortize in 13 equal monthly installments commencing in the third month of the term. The convertible debenture is convertible into registered common stock of the Company at $0.82 per share. The principal and interest payments are payable in cash or, at the Company's option, the lesser of registered stock valued at a 10% discount to the average of the 20-day VWAP as of the payment date or $0.82, subject to certain restrictions. The transaction terms include 100% five-year warrant coverage at a per share exercise price equal to a 10% premium to the 10-day VWAP on the closing date and a 100% additional investment right exercisable for up to twelve months following the effective date of the registration statement in respect of the transaction.

Proceeds related to the AIR Exercise, net of issuance costs of $49,250, amounted to $450,750. Included in the issuance costs were warrants to purchase 15,000 shares of common stock at $0.95 per share and commissions of $35,000 issued to a third party. The fair value of the warrant was determined to be $14,250 using the Black Scholes pricing model assuming a risk-free rate of 3.76 percent, an expected volatility of 0.9322 and a five year life. The fair value of the warrant, which has been allocated to additional paid in capital, together with the $35,000 of issuance costs associated with the shares of common stock issued are being amortized over the life of the debt as a deferred debt issuance cost. During the six months ended January 31, 2006, $9,849 has been amortized as interest expense and the remaining unamortized balance of $39,401 is included in deferred debt issuance costs.

The holder of the convertible debenture also received warrants to purchase 609,756 shares of common stock at $0.82 per share. In accordance with EITF 00-27, the Company recognized the value attributable to the warrants in the amount of $270,950 to additional paid-in capital and a discount against the convertible debenture. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 3.76 percent, an expected volatility of 0.9232 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible debenture’s maturity period as interest expense using the effective yield method.

In accordance with EITF 98-5 the Company recognized the value attributable to the beneficial conversion feature valued at $229,050, to additional paid-in capital and a discount against the convertible debenture. The debt discount attributed to the beneficial conversion feature is amortized over the convertible debenture's maturity period as interest expense using the effective yield method.

 
14


 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

Second $500,000 Convertible Debenture (Continued)
The Company amortized the convertible debenture debt discount attributed to the beneficial conversion feature and the value of the warrants and recorded non-cash interest expense of $119,364 for the six months ended January 31, 2006. During the six months ended January 31, 2006, the Company has not received any notice of conversions of principal and interest.

The Company has repaid the note holders $43,962 of the principal and interest in 53,612 shares of common stock during the six months ended January 31, 2006. This repayment resulted in a gain of ($536) to loss on extinguishment of debt that represents the difference between quoted market price of the Company’s common stock and 10 percent discount to the average of the 20-day VWAP.

$3,500,000 Convertible Debenture
On December 4, 2005, the Company and each of the holders of the $4 million convertible debenture entered into an Amendment No. 2 to Securities Purchase Agreement and Registration Rights Agreement pursuant to which (i) all but one of the Investors agreed to exercise an aggregate of $1,500,000 in principal amount (“$3.5 Million Convertible Debenture”) of the Additional AIRs granted to such Investors in connection with the First AIR Exercise resulting in a $3,500,000 convertible promissory note (“convertible debenture’) for an aggregate proceeds of $3,500,000. The convertible debenture carries a 6% coupon and a 15-month term and amortize in 13 equal monthly installments commencing in the third month of the term. The convertible debenture is convertible into registered common stock of the Company at $0.82 per share. The principal and interest payments are payable in cash or, at the Company's option, the lesser of registered stock valued at a 10% discount to the average of the 20-day VWAP as of the payment date or $0.82, subject to certain restrictions. The transaction terms include 100% five-year warrant coverage at a per share exercise price equal to a 10% premium to the 10-day VWAP on the closing date and a 100% additional investment right exercisable for up to twelve months following the effective date of the registration statement in respect of the transaction.

Proceeds related to the AIR Exercise, net of issuance costs of $15,000, amounted to $3,485,000. Included in the issuance costs were warrants to purchase 105,000 shares of common stock at $0.82 per share and 224,000 shares of common stock valued at $0.95 per share issued to a third party. The fair value of the warrant was determined to be $76,650 using the Black Scholes pricing model assuming a risk-free rate of 4.02 percent, an expected volatility of 0.9288 and a five year life. The fair value of the warrant, which has been allocated to additional paid in capital, together with the $212,800 of issuance costs associated with the shares of common stock issued and $15,000 of legal costs are being amortized over the life of the debt as a deferred debt issuance cost. During the six months ended January 31, 2006, $237,457 has been amortized as interest expense and the remaining unamortized balance of $33,743 is included in deferred debt issuance costs.

The holder of the convertible debenture also received warrants to purchase 4,268,292 shares of common stock at $0.82 per share. In accordance with EITF 00-27, the Company recognized the value attributable to the warrants in the amount of $1,648,387 to additional paid-in capital and a discount against the convertible debenture. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 4.02 percent, an expected volatility of 0.9288 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible debenture’s maturity period as interest expense using the effective yield method.
 
 
15


 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

$3,500,000 Convertible Debenture (Continued)
In accordance with EITF 98-5 the Company recognized the value attributable to the beneficial conversion feature valued at $1,851,613, to additional paid-in capital and a discount against the convertible debenture. The debt discount attributed to the beneficial conversion feature is amortized over the convertible debenture's maturity period as interest expense using the effective yield method.

The Company amortized the convertible debenture debt discount attributed to the beneficial conversion feature and the value of the warrants and recorded non-cash interest expense of $3,080,631 for the six months ended January 31, 2006. During the six months ended January 31, 2006, the Company has issued 3,673,632 shares of common stock to the holders of the convertible debentures upon receipt of the holders’ notice of conversions of principal and interest totaling $3,012,376. This conversion resulted in a charge of $538,629 to loss on extinguishment of debt that represents the difference between quoted market price of the Company’s common stock and 10 percent discount to the average of the 20-day VWAP.

During the six months ended January 31, 2006, the Company has not repaid monthly principal and interest through the issuance of shares of common stock.

Second $4,000,000 Convertible Debenture
On January 20, 2006, the Company and each of the holders of the $4 million convertible debenture entered into an Amendment No. 2 to Securities Purchase Agreement and Registration Rights Agreement pursuant to which the investors agreed to exercise an additional $4,000,000 in principal amount of Additional Investment Rights (AIR) (“Second $4 Million Convertible Debenture”) of the Additional AIRs granted to such Investors in connection with the First AIR Exercise resulting in a $4,000,000 convertible promissory note (“convertible debenture’) for an aggregate proceeds of $4,000,000. The convertible debenture carries a 6% coupon and a 15-month term and amortize in 13 equal monthly installments commencing in the third month of the term. The convertible debenture is convertible into registered common stock of the Company at $1.05 per share. The principal and interest payments are payable in cash or, at the Company's option, the lesser of registered stock valued at a 10% discount to the average of the 20-day VWAP as of the payment date or $0.82, subject to certain restrictions. The transaction terms include 100% five-year warrant coverage at a per share exercise price equal to a 10% premium to the 10-day VWAP on the closing date and a 100% additional investment right exercisable for up to twelve months following the effective date of the registration statement in respect of the transaction.

Proceeds related to the AIR Exercise, net of issuance costs of $15,000, amounted to $3,985,000. Included in the issuance costs were warrants to purchase 120,000 shares of common stock at $1.05 per share and 266,667 shares of common stock valued at $1.00 per share issued to a third party. The fair value of the warrant was determined to be $88,800 using the Black Scholes pricing model assuming a risk-free rate of 4.23 percent, an expected volatility of 0.9210 and a five year life. The fair value of the warrant, which has been allocated to additional paid in capital, together with the $266,667 of issuance costs associated with the shares of common stock issued and $15,000 of legal costs are being amortized over the life of the debt as a deferred debt issuance cost. During the six months ended January 31, 2006, $7,887 has been amortized as interest expense and the remaining unamortized balance of $362,580 is included in deferred debt issuance costs.
 
 
16

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

6.  
Convertible Debentures (Continued)

Second $4,000,000 Convertible Debenture (Continued)
The holder of the convertible debenture also received warrants to purchase 3,809,524 shares of common stock at $1.05 per share. In accordance with EITF 00-27, the Company recognized the value attributable to the warrants in the amount of $1,653,631 to additional paid-in capital and a discount against the convertible debenture. The Company valued the warrants in accordance with EITF 00-27 using the Black-Scholes pricing model assuming a risk-free rate of 4.23 percent, an expected volatility of 0.9210 and a five year life. The debt discount attributed to the value of the warrants issued is amortized over the convertible debenture’s maturity period as interest expense using the effective yield method.

In accordance with EITF 98-5 the Company recognized the value attributable to the beneficial conversion feature valued at $1,463,155, to additional paid-in capital and a discount against the convertible debenture. The debt discount attributed to the beneficial conversion feature is amortized over the convertible debenture's maturity period as interest expense using the effective yield method.

During the six months ended January 31, 2006, the Company has not received any notice of conversions of principal and interest.

During the six months ended January 31, 2006, the Company has not repaid monthly principal and interest through the issuance of shares of common stock.

7.  
Short-term Advance
On March 30, 2005, the Company entered into an agreement with an affiliated party to provide the Company with approximately $325,200 in funding. The funds were designated to assist the Company in satisfying its obligations under the terms of the first $4,000,000 convertible debenture agreements. The Company is obligated to repay the advance, without interest, in three equal installments on October 1, 2005, November 1, 2005 and December 1, 2005. Upon failure to repay any installment when due, all amounts become payable on demand and interest on such unpaid amounts will accrue interest at the rate of 8 percent per annum. The Company did not make the required installments, therefore, has accrued interest in the amount of $22,190, $6,658 and $13,732 of which is included in the consolidated statements of operations for the three and six months ended January 31, 2006, respectively, and $-0- for the three and six months ended January 31, 2005.

8.  
Pending Litigation
On October 2, 1998, Sands Brothers & Co. Ltd. (“Sands”), a New York City-based investment banking and brokerage firm, initiated an arbitration proceeding against the Company under the rules of the New York Stock Exchange in respect of an alleged contractual relationship between Sands and the Company.

On August 17, 2004, following various arbitration and court proceedings in the case, the Arbitration Panel of the New York Stock Exchange issued a final award in the case, awarding Sands $150,000 in damages.  A motion to confirm this award was granted on February 1, 2005.  In September 2005 Sands filed a motion seeking leave from the New York Court of Appeals to appeal certain prior orders of the Appellate Division in the case. On January 10, 2006 the New York Court of Appeals denied the motion.. In March, 2006 the Company paid $150,000 plus $10,541 in interest to Sands in satisfaction of the judgment.
 
 
17


 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

8.  
Pending Litigation (Continued)
In February 2001, a former business associate of the former Vice President of Research and Development (VP), and an entity called 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 the company called CTI. 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.

In February 2005, a consultant commenced an action in the Ontario Superior Court of Justice against the Company seeking approximately $600,000 in damages for alleged contract breaches in respect of unpaid remuneration and other compensation allegedly owed to him. The Company is of the view that the claims are wholly without merit 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 estimate an amount or range of potential loss, if any, from this legal proceeding.

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 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.

9.  
Net Loss Per Share
Basic EPS and Diluted EPS for the three months and six months ended January 31, 2006 and 2005 have been computed by dividing the net loss for each respective period by the weighted average number of shares outstanding during that period. All outstanding warrants and options, approximately 37,791,029 and 22,095,502 incremental shares at January 31, 2006 and 2005, respectively, have been excluded from the computation of Diluted EPS as they are anti-dilutive.
 
 
18


 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


10.  
Supplemental Disclosure of Cash Flow Information
 
 
 For the Six Months Ended 
 
 
 
  January 31, 
 
   
 2006
 
   2005  
 
           
 Cash paid during the period for:          
 Interest 
  $ 56,427   $ $76,220  
 Income taxes 
  $ --   $ --  
               
 Disclosure of non-cash investing and financing activities:              
               
 Value of common stock issued in conjunction with capitalized              
 services upon issuance of convertible debentures 
  $ 619,467   $ --  
 Value of warrants issued in conjunction with capitalized              
 services upon issuance of convertible debentures 
  $ 210,300   $ 89,900  
 Costs paid from proceeds in conjunction with capitalized              
 services upon issuance of convertible debentures 
  $ 45,000   $ --  
 Value of warrants issued in conjunction with issuance of              
 convertible debentures and related beneficial conversion
             
 feature
  $ 9,087,156   $ 3,444,444  
 Satisfaction of accounts payable through the issuance of              
 common stock 
  $ 133,605   $ --  
 Principal repayment of convertible debentures through the              
 issuance of common stock 
  $ 1,075,764   $ --  
 Issuance of common stock in conjunction with convertible              
 debenture conversion 
  $ 6,963,007   $ --  
 Sale of Series A Preferred Stock and mandatorily converted              
 to common shares
  $ --   $
14,310,057
 
 
11.  
Transactions with Related Party
The Company’s change in “Due from Related Party” for the six months ended January 31, 2006 represents only the effect of change in exchange rate for the six months ended versus that in effect at July 31, 2005.

12.  
Stockholders’ Equity
In August 2005, the Company issued 265,929 shares of common stock to various consultants for services rendered in the amount of $157,289. The shares were valued at $0.59 to $0.61 per share based on the quoted market price of the Company’s common stock on the dates of the issuances.

In September 2005, the Company issued 162,933 shares of common stock to various vendors for the satisfaction of $113,605 of accounts payable and accrued liabilities. The shares were valued at $0.81 per share based on the quoted market price of the Company’s common stock on the dates of the issuances.

 
19

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

12.  
Stockholders’ Equity (Continued)
In September 2005, the Company and each of the holders of the $4 million convertible debenture entered into an Amendment No. 2 to Securities Purchase Agreement and Registration Rights Agreement pursuant to which the investors agreed to exercise an additional $2,000,000 in principal amount of Additional Investment Rights (AIR) (“Second $2 Million Convertible Debenture”). In connection with this investment, the Company agreed to issue warrants to purchase an aggregate of 2,439,024 shares of the Company’s common stock at the exercise price of $0.82 per share exercisable for five years commencing six months following the issuance thereof and to grant each investor further AIR. In addition, in connection with the transaction contemplated by Amendment No. 2, the Company issued a placement agent (i) 170,732 shares of common stock in lieu of a cash fee equal to 7 percent of the gross proceeds received by the Company and (ii) warrants exercisable into approximately 60,000 shares of common stock at the same exercise price as the AIR warrants (see Note 6).

In October 2005 one of the debenture holders exercised its additional investment right “AIR Exercise” resulting in a $500,000 convertible promissory note (“$500,000 Convertible Debenture’) for an aggregate proceeds of $500,000. In connection with this investment, the Company agreed to issue warrants to purchase an aggregate of 609,756 shares of the Company’s common stock at the exercise price of $0.82 per share exercisable for five years commencing six months following the issuance thereof. In addition, in connection with the transaction, the Company issued a placement agent warrants to purchase 15,000 shares of common stock (see Note 6).

In October 2005, the Company issued an aggregate of 909,756 warrants to certain debenture holders as an incentive to exercise their existing warrants. All warrants have a five year term, an exercise price of $1.20 per share and were valued at $0.63. The warrants, which were valued using the Black-Scholes pricing model with expected volatility of 93.22 percent and risk free interest of 3.76 percent, resulted in charges to the interest expense of $573,146.

In October 2005, the Company issued an aggregate of 2,748,780 warrants to certain debenture holders as an incentive to exercise their existing warrants. All warrants have a five year term, an exercise price of $1.25 per share and were valued at $0.91. The warrants, which were valued using the Black-Scholes pricing model with expected volatility of 93.22 percent and risk free interest of 3.76 percent, resulted in charges to the interest expense of $2,501,390.

In October 2005, the Company received aggregate cash proceeds of approximately $6,891,998. The Company issued 8,404,876 shares of common stock as a result of these transactions.

In October 2005, the Company received aggregate cash proceeds of $101,545 from exercises of stock options. The Company issued 141,500 shares of common stock as a result of these transactions.

In November 2005, the Company received aggregate cash proceeds of $94,945 from exercises of stock options. The Company issued 101,500 shares of common stock as a result of these transactions.

In November 2005, the Company received aggregate cash proceeds of $2,508,000 from exercises of stock warrants. The Company issued 3,058,536 shares of common stock as a result of these transactions.
 

20

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

12.  
Stockholders’ Equity (Continued)
In November 2005, the Company issued 83,787 shares of common stock to consultants for services rendered in the amount of $81,274. The shares were valued at $0.97 per share based on the quoted market price of the Company’s common stock on the dates of the issuances.

In December 2005, the Company and each of the holders of the $4 million convertible debenture entered into an Amendment No. 2 to Securities Purchase Agreement and Registration Rights Agreement pursuant to which (i) all but one of the Investors agreed to exercise an aggregate of $1,500,000 in principal amount of the Additional AIRs granted to such Investors in connection with the First AIR Exercise and (ii) all of the Investors agreed to exercise an aggregate of $2,000,000 in principal amount of the Additional AIRs granted to the Investors in connection with the Second AIR Exercise (“$3.5 Million Convertible Debenture”). In connection with the $3.5 Million Convertible Debenture, the Company agreed to issue warrants to purchase an aggregate of 4,268,292 shares of the Company’s common stock at the exercise price of $0.82 per share exercisable for five years commencing six months following the issuance thereof and to grant each investor further AIR. In addition, in connection with the transaction contemplated by Amendment No. 2, the Company issued a placement agent (i) 224,000 shares of common stock in lieu of a cash comission and (ii) warrants exercisable into approximately 105,000 shares of common stock at the same exercise price as the AIR warrants (see Note 6).

In December 2005, the Company issued an aggregate of 1,829,268 warrants to certain debenture holders as an incentive to exercise their existing warrants. All warrants have a five year term, an exercise price of $1.25 per share and were valued at $0.61. The warrants, which were valued using the Black-Scholes pricing model with expected volatility of 0.9254 percent and risk free interest of 4.02 percent, resulted in charges to the interest expense of $1,115,853.

In January 2006, the Company and each of the holders of the $4 million convertible debenture entered into an Amendment No. 4 to Securities Purchase Agreement and Registration Rights Agreement pursuant to which the investors agreed to exercise an additional $4,000,000 in principal amount of Additional Investment Rights (AIR) (“Second $4 Million Convertible Debenture”). In connection with this investment, the Company agreed to issue warrants to purchase an aggregate of 3,809,524 shares of the Company’s common stock at the exercise price of $1.05 per share exercisable for five years commencing six months following the issuance thereof and to grant each investor further AIR. In addition, in connection with the transaction contemplated by Amendment No. 2, the Company issued a placement agent (i) 266,667 shares of common stock in lieu of a cash fee equal to 7 percent of the gross proceeds received by the Company and (ii) warrants exercisable into approximately 120,000 shares of common stock at the same exercise price as the AIR warrants (see Note 6).

In January 2006, the Company received aggregate cash proceeds of $6,300 from exercises of stock options. The Company issued 10,000 shares of common stock as a result of these transactions.

In January 2006, the Company received aggregate cash proceeds of $5,999,999 from exercises of stock warrants. The Company issued 7,317,072 shares of common stock as a result of these transactions.
 
 
21

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

12.  
Stockholders’ Equity (Continued)
In January 2006, the Company issued an aggregate of 3,658,536 warrants to certain debenture holders as an incentive to exercise their existing warrants. All warrants have a five year term, an exercise price of $1.60 per share and were valued at $0.85. The warrants, which were valued using the Black-Scholes pricing model with expected volatility of 0.9210 percent and risk free interest of 4.23 percent, resulted in charges to the interest expense of $3,109,756.

During the six months ended January 31, 2006, the Company issued an aggregate of 1,918,199 shares of common stock as monthly principal and interest payments totaling $1,442,484 of convertible debentures (see Note 6).

During the six months ended January 31, 2006, the Company issued an aggregate of 9,822,145 shares of common stock resulting from the conversion of $7,643,960 of principal and accrued interest of convertible debentures (see Note 6).

The issuances of common stock as described above are summarized as follow:
 
           
 Additional 
 
 Total
 
   
 Common Stock 
 
 Paid-In
 
  Stockholders’
 
   
 Shares  
 
 Amount
 
 Capital 
 
 Equity
 
 Convertible Debenture Conversions      9,822,145   $ 9,822   $ 7,634,140   $ 7,643,962  
 Convertible Debenture Monthly                          
 Repayments
    1,918,199     1,918     1,439,565     1,441,483  
 Warrants and Stock Options Exercised                          
 for Cash 
    19,033,484     19,033     15,583,754    
15,602,787
 
 Issuance for Services and Accounts                          
 Payable
    1,174,048     1,174     970,460     971,634  
                           
 Total 
    31,947,876   $ 31,947   $ 25,627,919   $ 25,659,866  
 
13.  
Subsequent Events
During February 2006, the Company secured a commercial mortgage in the amount of $1,300,000, interest at 6.07 percent per annum and maturing March 2009. The proceeds from the mortgage were used to pay off existing debt as well as fees associated with obtaining the mortgage.

During February 2006, the Company received an aggregate of $11 million as a result of the exercise by existing Company investors of previously issued warrants.

During February 2006, the Company issued an aggregate of 4,770,617 warrants to certain debenture holders as an incentive to exercise their existing warrants. All warrants have a five year term, an exercise price of $3.00 per share and were valued at $1.74. The warrants, which were valued using the Black-Scholes pricing model with expected volatility of 0.9380 percent and risk free interest of 4.49 percent, resulted in charges to the interest expense of $8,294,141.

On February 28, 2006, each of the holders of additional investment rights (“AIR”) received in connection with Second 4 million Convertible Debenture exercised 100% of the AIRs (for aggregate gross proceeds to the Company of $4,000,000) in exchange for the acceleration of the exercise periods from July 20, 2006 to February 28, 2006.
 
 
22

 
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

13.  
Subsequent Events (Continued)
On March 6, 2006, the Company and the holders of the convertible debentures amended the terms of outstanding warrants received in conjunction with the transaction dated February 28, 2006 to purchase common stock to accelerate their exercise date to March 6, 2006. These warrants consist of warrants for 1,600,000 shares issued on February 28, 2006, and initially exercisable on August 31, 2006. The Investors agreed to immediately exercise the full amount of these warrants (for aggregate gross proceeds to the Company of $2,000,000) in exchange for (a) the acceleration of the exercise period, and (b) the issuance of additional warrants equal to 50% of the exercised Warrants (an aggregate of at least 800,000 shares). The new warrants will have an exercise price of $3.00 per share and will be exercisable for five years from September 6, 2006. The warrants were valued at $1.62 using the Black-Scholes pricing model with expected volatility of 0.9377 percent and risk free interest of 4.49 percent, resulting in charges to the interest expense of $1,293,953.


In February and March 2006, the Company issued an aggregate of 2,390,111 shares of common stock resulting from the conversion of $2,509,540 of the principal and accrued interest of the Second $4,000,000 Convertible Debenture (See Note 6).

In March 2006, the Company issued an aggregate of 2,280,592 shares of common stock resulting from the conversion of $2,850,740 of the principal and accrued interest of convertible debenture entered pursuant to the exercise of AIRs on February 28, 2006.

In February and March 2006, the Company issued an aggregate of 1,503,454 shares of common stock resulting from the exercise of outstanding warrants and stock options for cash. The Company received an aggregate amount of approximately $2,270,804 in proceeds as a result of these transactions.

 
23

 

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.

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, 2006 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 "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" 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:

 
Ÿ
our expectations concerning product candidates for our technologies;
 
Ÿ
our expectations concerning existing or potential development and license agreements for third-party collaborations and joint ventures;
 
Ÿ
our expectations of when different phases of clinical activity may commence or be completed;
  Ÿ 
our expectations of when regulatory submissions may be filed or when regulatory approvals may be received; and
  Ÿ
our expectations in respect of the timing and results of commercialization activities.
 
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:

 
Ÿ
the inherent uncertainties of product development based on our new and as yet not fully proven technologies;
 
Ÿ
the risks and uncertainties regarding the actual effect on humans of seemingly safe and efficacious formulations and treatments when tested clinically;
 
Ÿ
the inherent uncertainties associated with clinical trials of product candidates;
 
Ÿ
the inherent uncertainties associated with the process of obtaining regulatory approval to market product candidates;
 
Ÿ
the inherent uncertainties associated with commercialization of products that have received regulatory approval; and
 
Ÿ
our ability to obtain the necessary financing to fund our operations.

Additional factors that could affect future results are set forth below under the caption Risk Factors. 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 made in this Quarterly Report 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.

 
24


 
Corporate History

We were incorporated in Delaware in September 1997 for the purpose of acquiring Generex Pharmaceuticals, Inc., a Canadian corporation formed in November 1995 to engage in pharmaceutical and biotechnological research and other activities. Our acquisition of Generex Pharmaceuticals was completed in October 1997 in a transaction in which the holders of all outstanding shares of Generex Pharmaceuticals exchanged their shares for shares of our common stock.

In January 1998, we participated in a "reverse acquisition" with Green Mt. P. S., Inc., a previously inactive Idaho corporation formed in 1983. As a result of this transaction, our shareholders (the former shareholders of Generex Pharmaceuticals) acquired a majority (approximately 90%) of the outstanding capital stock of Green Mt., we became a wholly-owned subsidiary of Green Mt., Green Mt. changed its corporate name to Generex Biotechnology Corporation ("Generex Idaho"), and we changed our corporate name to GB Delaware, Inc. Because the reverse acquisition resulted in our shareholders becoming the majority holders of Generex Idaho, we were treated as the acquiring corporation in the transaction for accounting purposes. Thus, our historical financial statements, which essentially represented the historical financial statements of Generex Pharmaceuticals, were deemed to be the historical financial statements of Generex Idaho.

In April 1999, we completed a reorganization in which we merged with Generex Idaho. In this transaction, all outstanding shares of Generex Idaho were converted into our shares, Generex Idaho ceased to exist as a separate entity, and we changed our corporate name back to "Generex Biotechnology Corporation." This reorganization did not result in any material change in our historical financial statements or current financial reporting.

In August 2003, we acquired Antigen Express, Inc. Antigen is engaged in the research and development of technologies and immunomedicines for the treatment of malignant, infectious, autoimmune and allergic diseases.

Business History

We are engaged primarily in the research and development of drug delivery 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.

Our first product is an insulin formulation that is administered as a fine spray into the oral cavity using a hand-held aerosol spray applicator. Between January 1999 and September 2000, we conducted limited clinical trials on this product in the United States, Canada and Europe. In September 2000, we entered into an agreement (the "Development and License Agreement") to develop this product with Eli Lilly and Company ("Lilly"). To date, over 1,100 patients with diabetes have been dosed with our oral insulin product at approved facilities in seven countries. We conducted several clinical trials with insulin supplied by Lilly under our Development and License Agreement. Lilly did not, however, authorize or conduct any clinical trials or provide financial support for those trials. We did receive a $1,000,000 upfront payment from Lilly. On May 23, 2003, we announced that we had agreed with Lilly to end the Development and License Agreement for the development and commercialization of buccal delivery of insulin. On November 5, 2003, we entered into a termination agreement with Lilly terminating the Development and License Agreement, effective as of June 2, 2003. In accordance with the termination agreement, we retained all of the intellectual property and commercialization rights with respect to buccal spray drug delivery technology, and we have the continuing right to develop and commercialize the product. We also entered into a Bulk Supply Agreement (the "Bulk Supply Agreement") for the sale of human insulin crystals by Lilly to us over a three-year period.

In January 2001, we established a joint venture with Elan International Services, Ltd. ("EIS"), a wholly-owned subsidiary of Elan Corporation, plc (EIS and Elan Corporation, plc being collectively referred to as "Elan"), to pursue the application of certain of our and Elan's drug delivery technologies, including our platform technology for the buccal delivery of pharmaceutical products, for the treatment of prostate cancer, endometriosis and/or the suppression of testosterone and estrogen. In January 2002, we and Elan agreed to expand the joint venture to encompass the buccal delivery of morphine for the treatment of pain and agreed to pursue buccal morphine as the initial pharmaceutical product for development under Generex (Bermuda) Ltd., the entity through which the joint venture was being conducted. This expansion of the joint venture occurred after we successfully completed a proof of concept clinical study of morphine delivery using our proprietary buccal delivery technology.
 
 
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In connection with the joint venture, EIS purchased 1,000 shares of our Series A Preferred Stock for $12,015,000, which EIS transferred, shortly thereafter, to Elan Pharmaceuticals Investment III, an affiliate of Elan ("EPIL III"). We applied the proceeds from the sale of the Series A Preferred Stock to subscribe for an 80.1% equity ownership interest in Generex (Bermuda), Ltd. EIS paid in capital of $2,985,000 to subscribe for a 19.9% equity ownership interest in the joint venture entity. In accordance with the terms of the Series A Preferred Stock, if any shares of Series A Preferred Stock were to be outstanding on January 16, 2007, we would have been required to redeem the shares of Series A Preferred Stock at a redemption price equal to the aggregate Series A Preferred Stock liquidation preference, either in cash, or in shares of common stock with a fair market value equal to the redemption price. Alternatively, the Series A Preferred Stock could have been converted, under certain conditions, into shares of our common stock. EIS also purchased 344,116 shares of our common stock for $5,000,000. We were permitted to use the proceeds of this sale for any corporate purpose.

On December 27, 2004, we entered into an agreement (the "Termination Agreement") with Elan, whereby we and Elan agreed to terminate the joint venture through Generex (Bermuda) Ltd. Pursuant to the terms of the Termination Agreement, (i) except for a common stock purchase warrant that was issued by us to Elan, which was amended to permit Elan or any other holder thereof to transfer the warrant without our consent, the parties agreed to terminate all agreements entered into in connection with the joint venture, and (ii) Elan agreed to transfer all shares of capital stock of Generex (Bermuda) owned by it to us. Accordingly, all rights granted by each party to the other terminated, including, without limitation, Elan's right to appoint a member to our Board of Directors, all other rights granted under the terms of the joint venture terminated, each party retained its intellectual property rights, we obtained full ownership of Generex (Bermuda), and all representatives of Elan who were officers and/or directors of Generex (Bermuda) resigned.

In connection with negotiating the Termination Agreement, EPIL III approached us for consent to transfer the Series A Preferred Stock by way of an auction process. Although we provided our consent to the transfer, it was contingent upon EPIL III agreeing to satisfy the following conditions: (i) the auction process could conclude no later than December 15, 2004 and EPIL III's disposition of the shares could conclude no later than December 31, 2004 (the "Closing Date"), (ii) the buyer had to immediately convert the Series A Preferred Stock at the voluntary conversion price of $25.77 (calculated pursuant to the terms of the certificate of designation for the Series A Preferred Stock resulting in the issuance of 534,085 shares of common stock), (iii) EPIL III's registration rights could not be transferred, and (iv) for a period of two (2) years after the Closing Date, the purchaser of the Series A Preferred Stock could not transfer the shares of common stock issuable upon conversion thereof and we would have the right to redeem the shares of common stock at a per share price of 150% of the average closing price of the common stock on The Nasdaq Capital Market for the twenty (20) days immediately preceding the Closing Date. On or about December 15, 2004, EPIL III conducted the auction and received an offer to buy the shares of Series A Preferred Stock. On or about December 31, 2004, EPIL III sold the shares of Series A Preferred Stock, and the purchaser thereof immediately converted the Series A Preferred Stock into shares of our common stock.

The conversion of the Series A Preferred Stock was particularly critical because the mandatory redemption feature required us to classify the Series A Preferred Stock as approximately $14,300,000 of mezzanine equity. Upon conversion of the Series A Preferred Stock, however, we were able to reclassify the approximately $14,300,000 of mezzanine equity as common equity on our balance sheet. This, in turn, allowed us to regain compliance with NASDAQ's Marketplace Rule 4310(c)(2)(B), which requires us to have a minimum of $2,500,000 in stockholders' equity or $35,000,000 market value of listed securities or $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recently completed fiscal years.
 
 
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In August 2003, we acquired Antigen Express, Inc. Antigen is engaged in the research and development of technologies and immunomedicines for the treatment of malignant, infectious, autoimmune and allergic diseases.

Our immunomedicine products 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 that were discovered by a former executive officer of Antigen, the Ii-Key hybrid peptides and Ii-Suppression. Phase 1 clinical testing in humans has commenced at The Walter Reed Army Medical Center in respect of a vaccine designed to stimulate an immune response against the tumor-causing gene HER-2/neu, which occurs in a significant percentage of patients with breast cancer as well as other cancers. The other immunomedicine products, including a vaccine for avian influenza, are in the pre-clinical stage of development, and trials in human patients are not expected for at least six months. Development efforts are underway in melanoma, breast cancer, prostate cancer, HIV, the avian influenza virus, smallpox, SARS and Type I diabetes mellitus. We are establishing collaborations with clinical investigators at academic centers to advance the technology, with the ultimate goal of conducting human clinical testing.

With the anticipated commencement of commercial sales of our oral insulin product, Generex Oral-lyn™, in Ecuador in the fourth quarter of our fiscal 2006, we expect to receive revenues from product sales in the fiscal year ending July 31, 2006. We do not expect this revenue to be sufficient for all of our cash needs during the year. In the past we were able to fund Antigen expenses with some revenue from research grants for Antigen's immunomedicine products. During the fiscal quarter ended January 31, 2006, we received a total of $43,750 in such research grants, and we have received a total of $87,500 in such grants in fiscal 2006. We do not expect to receive such grants on a going forward basis. We expect to satisfy the majority of our cash needs during the current year from capital raised through debt and equity financings.

Disclosure Regarding Research and Development Projects

Our major research and development projects (in addition to the Antigen Express projects referenced above) are the refinement of our platform buccal delivery technology, our buccal insulin project (Generex Oral-lyn™),our buccal morphine product, our buccal glucose project (Glucose RapidSpray™, an over-the-counter confectionary), and our buccal metoformin project (metformin gum).

Our insulin product is in clinical trials. During the last fiscal year, we did not expend resources to further our buccal morphine product. In Canada, we are in the process of finalizing work for a New Drug Submission (NDS) to the Biologics and Genetic Therapeutics Directorate of Health Canada for approval for the marketing and sale of Generex Oral-lyn™ in Canada. We expect that the NDS will be a blueprint for similar applications to the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) however we cannot predict at this time when such applications will be made, what additional work will be required by us before such applications are granted, how long such work will take, or how much funding will be required to complete such work.

Our insulin product, Generex Oral-lyn™, was approved for commercial sale by drug regulatory authorities in Ecuador in early May 2005 for the treatment of patients with either Type-1 or Type-2 diabetes mellitus.. It is our intention that our South American joint venture partner, PharmaBrand S.A., will handle the commercial production and sale of Generex Oral-lyn™ in Ecuador. We expect that commercial sales of Generex Oral-lyn™ will commence in Ecuador before the end of current calendar year.

Because of various uncertainties, we cannot predict the timing of completion and commercialization of our buccal insulin product or the other products presently under development. These uncertainties include the success of current studies, our ability to obtain the required financing, the time required to obtain regulatory approval even if our research and development efforts are completed and successful, and the availability of and our access to production facilities and distribution channels. For the same reasons, we cannot predict when any products may begin to produce net cash inflows.
 
 
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Most of our buccal delivery research and development activities to date have involved developing our platform technology for use with insulin and morphine. Insubstantial amounts have been expended on projects with other drugs, and those projects involved a substantial amount of platform technology development. Therefore, in the past, 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 is expected to benefit all of our potential products. During the six month ended January 31, 2006, approximately 74% of our $1,993,494 in research expenses was attributable to insulin and platform technology development, and did not spend any money on morphine and fentanyl projects. In the comparable period ended January 31, 2005, approximately 87% of our $5,576,965 of research and development was expended for insulin and platform technology, and approximately 1% for morphine and fentanyl.

Approximately 26% or $512,446 of our research and development expenses for the six months ended January 31, 2006 were related to Antigen's immunomedicine products compared to approximately 12% or $690,718 for the same period last year. Because these products are in a very early, pre-clinical stage of development (other than the breast cancer vaccine which is in Phase 1 trials), all of the expenses were accounted for as basic research and no distinctions were made as to particular products. Because of the early stage of development, we cannot predict the timing of completion of any products arising from the Antigen Express is technology, or when products from this technology might begin producing revenues.

Developments in Fiscal Quarter Ended January 31, 2006

On November 14, 2005, we received written confirmation from the Staff of The Nasdaq Stock Market that we had achieved compliance with the continued listing requirements in accordance with Marketplace Rule 4310(c)(4), which requires us to have a minimum closing bid price per share of at least $1.00 for 30 consecutive trading days. Although we have regained compliance with the minimum closing bid price requirement, there is no guarantee that the closing bid price of our common stock will remain at or above $1.00 per share. In the event that the closing bid price of our common stock falls below $1.00 per share for thirty (30) consecutive trading days, we would likely receive a notice from The Nasdaq Stock Market informing us of our noncompliance with Marketplace Rule 4310(c)(4) and giving us 180 calendar days, subject to extension, to regain compliance with the Rule. In the event that we could not demonstrate compliance with Marketplace Rule 4310(c)(4) by the specified deadline and were not eligible for an additional compliance period, the Staff would notify us that our stock would be delisted, at which time we could appeal the Staff’s determination to a Listing Qualifications Panel. Pending the decision of the Listing Qualification Panel, our common stock would continue to trade on the Nasdaq Capital Market. If we were not successful in such an appeal, our stock would likely trade on NASDAQ’s over-the-counter bulletin board, assuming we meet the requisite criteria.

On December 4, 2005, the Company and four accredited investors entered into Amendment No. 3 (“Amendment No. 3”) to the November 10, 2004 Securities Purchase Agreement (the “Securities Purchase Agreement”) and the November 10, 2004 Registration Rights Agreement (the “Registration Rights Agreement”) pursuant to which (i) the all of the investors except Omicron Master Trust (“Omicron”) agreed to exercise an aggregate of $1,500,000 in principal amount of the Additional Investment Rights (the “June AIRs”) granted to them in connection with their investment and exercise of previous Additional Investment Rights in June 2005 (Omicron had previously exercised its companion Additional Investment Right) and (ii) all of the investors, including Omicron, agreed to exercise an aggregate of $2,000,000 in principal amount of a second Additional Investment Right (the “Sept AIRs”) granted to them in connection with their investment and exercise of previous Additional Investment Rights in September 2005. Amendment No. 3, and the prior transactions under the Securities Purchase Agreement and Amendment No. 1 thereto and Amendment No. 2 thereto are described in full in our Current Report on Form 8-K filed with the SEC on December 5, 2005, and in our Quarterly Report on Form 10-Q in respect of our second fiscal quartered ended October 31, 2005 under Item 2- Management’s Discussion and Analysis of Financial Condition and results of Operation - Developments Subsequent to the Quarter Ended October 31, 2005.

Pursuant to Amendment No. 3, we and the investors, excluding Omicron, amended the June AIRs (the “June AIR Amendment”) to accelerate the initial exercise date in respect thereof (the 181st day following the date of issuance) in consideration of the full and immediate exercise by such investors of their June AIRs and the delivery to us of Notices of Exercise in respect thereof on or before the close of business on December 5, 2005. In addition, we and all four of the investors amended the Sept AIRs (the “Sept AIR Amendment”) to accelerate the initial exercise date in respect thereof (the 181st day following the date of issuance) in consideration of the full and immediate exercise by the investors of their Sept AIRs and the delivery to us of Notices of Exercise in respect thereof on or before the close of business on December 5, 2005.
 
 
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The investors timely delivered Notices of Exercise, satisfying the conditions specified in the June AIR Amendments and/or Sept AIR Amendments, as applicable. In connection with the exercise of the June AIRs and the Sept AIRs on December 5, 2005, each investor purchased a $1,000,000 principal amount AIR Debenture (except for Omicron which purchased a $500,000 principal amount AIR Debenture (previously, on October 27, 2005, Omicron had purchased an additional $500,000 principal amount AIR Debenture)) with a conversion price of $0.82 (collectively, the “December AIR Debentures”) and AIR Warrants entitling the investors to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion of the December AIR Debentures in full at a $0.82 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $0.82 per share (the “December AIR Warrants”). Accordingly, we issued to the investors December AIR Debentures in the aggregate principal amount of $3,500,000 and December AIR Warrants to purchase an aggregate of 4,268,292 shares of our common stock, exercisable for five years commencing six months following the issuance thereof. We received proceeds of approximately $3,500,000 in connection with the investors’ exercise of their June AIRs and their Sept AIRs.

The terms of the December AIR Debentures granted in connection with Amendment No. 3 are identical to those of the debentures previously issued under the auspices of the Securities Purchase Agreement. The terms of the December AIR Debentures are described below under the caption Financial Condition, Liquidity and Resources of this Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The December AIR Warrants issued to the investors on December 5, 2005 were initially exercisable into an aggregate of 4,268,292 shares of our common stock, and the initial exercise price of each December AIR Warrant was equal to $0.82.

In addition, in consideration of each investor’s exercise of its June AIRs and its Sept AIRs, including Omicron’s October 2005 exercise of its June AIR, we granted to each investor a further Additional Investment Right (each an “Amendment No. 3 AIR” and collectively, the “Amendment No. 3 AIRs”), pursuant to which each investor had the right to purchase detachable units consisting of (a) additional debentures in the principal amount of $1,000,000 each with a conversion price of $1.25 per share (the “Additional AIR Debentures”) and (b) additional warrants entitling the holder thereof to purchase a number of shares of the Company’s common stock equal to 100% of the shares of common stock issuable upon the conversion in full at a $1.25 per share conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) of the Additional AIR Debentures contemplated in clause (a) above, at an exercise price equal to $1.25 per share (the “Additional AIR Warrants”).

Each investor was entitled to exercise its Amendment No. 3 AIR at any time on or after the 181st day after closing and on or prior to the earlier of (i) the close of business on the one-year anniversary after the registration statement for the shares of common stock underlying Amendment No. 3 went effective and (ii) the two year anniversary of the closing of the transactions contemplated by Amendment No. 3.

Under the terms of Amendment No. 3, we also agreed to register for resale the securities issuable upon conversion/exercise of the Additional AIR Debentures and the Additional AIR Warrants, consistent with the investors’ existing registration rights under the Registration Rights Agreement. On February 1, 2006, we filed with the SEC a Registration Statement on Form S-3 (File No. 333-131430) in connection with Amendment No. 3. The Registration Statement became effective on February 24, 2006.
 
 
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In addition, in connection with the transactions contemplated by Amendment No. 3 and Omicron’s October 2005 exercise of its June AIR, we were required to pay to a placement agent (i) $245,000 in cash (7% of the gross proceeds received by us), which amount was actually converted into stock at $1.25 per share, and (ii) warrants exercisable into 105,000 shares of common stock at the same exercise price as the December AIR Warrants. These shares were also registered for resale in the Registration Statement.

On December 9, 2005, in consideration for the exercise of certain outstanding warrants previously issued to Cranshire Capital, L.P. (“Cranshire”) (otherwise than in connection with the Securities Purchase Agreement), one of the investors under the Securities Purchase Agreement, and in connection with the extension of the maturity date of its $500,000 Promissory Note and Agreement, we issued to Cranshire a five-year warrant to purchase an aggregate of 1,829,268 shares of our common stock at $1.25 per share. We received aggregate proceeds of approximately $3,000,000 in connection with the exercise of Cranshire’s outstanding warrants to purchase shares of our common stock. The rights of Cranshire under this warrant are described below under the caption Financial Condition, Liquidity and Resources of this Part I - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Exercise of Amendment No. 3 AIR Pursuant to Amendment No. 4

On January 19, 2006, we and each of the investors entered into Amendment No. 4 to the Securities Purchase Agreement and Registration Rights Agreement (the “Amendment No. 4”) pursuant to which the investors agreed to exercise the full amount of its Amendment No. 3 AIR to acquire an aggregate of $4,000,000 in principal amount of Additional AIR Debentures. Pursuant to each such Amendment No. 3 AIR granted in connection with Amendment No. 3, each investor had the right to purchase detachable units consisting of (a) Additional AIR Debentures in the principal amount of $1,000,000 with a conversion price of $1.25 per share and (b) Additional AIR Warrants entitling the holder thereof to purchase a number of shares of the Company’s common stock equal to 100% of the shares of common stock issuable upon the conversion in full at a $1.25 conversion price of the Additional AIR Debentures (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $1.25 per share.

Pursuant to Amendment No. 4, we amended the terms of the Amendment No. 3 AIRs to accelerate the initial exercise dates thereof to January 19, 2006 in consideration of their full and immediate exercise by the investors.

In connection with the exercise of each Amendment No. 3 AIR, each investor purchased a $1,000,000 principal amount Additional AIR Debenture with a conversion price of $1.05 (reduced from $1.25) and Additional AIR Warrants entitling the investor to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the Additional AIR Debenture at a reduced conversion price of $1.05 (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $1.05 per share (reduced from $1.25). Accordingly, we issued to the investors Additional AIR Debentures in the aggregate amount of $4,000,000 and Additional AIR Warrants to purchase an aggregate of 3,809,524 shares of our common stock, exercisable for five years commencing six months following the issuance thereof. Under the terms of Amendment No. 4, the reduction in the conversion price of the Additional AIR Debentures and the exercise price of the Additional AIR Warrants did not trigger any anti-dilution adjustments to any outstanding securities held by the investors.

We received proceeds of approximately $4,000,000 in connection with the investors’ exercise of their Amendment No. 3 AIRs.

The Additional AIR Debentures have a term of fifteen months and amortize over thirteen months in thirteen equal monthly installments beginning on the first day of the third month following their issuance. Interest on the principal amount outstanding accrues at a rate of 6% per annum. We may pay principal and accrued interest in cash or, at our option, in shares of our common stock. If the we elect to pay principal and/or interest in shares of our common stock, the value of each share of common stock is equal to the lesser of (i) $1.05 and (ii) ninety percent (90%) of the average of the daily volume weighted average price for the common stock over the twenty trading day period immediately preceding the date of payment. At the option of the holder of each Additional AIR Debenture, the principal amount outstanding under each Additional AIR Debenture is initially convertible at any time after the closing of Amendment No. 4 into shares of the our common stock at a conversion price of $1.05.
 
 
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Upon the occurrence of an “Event of Default,” including a default in payment of principal or interest (including late fees) which is not cured within three trading days, the full principal amount of each Additional AIR Debenture, together with interest and other amounts owing in respect thereof, to the date of acceleration will become, at the holder’s election, due and payable in cash. The aggregate amount payable upon an Event of Default will be equal to the “Mandatory Prepayment Amount.” The Mandatory Prepayment Amount for any Additional AIR Debentures will be equal to the sum of (i) the greater of: (A) 130% of the principal amount of Additional AIR Debentures to be prepaid, plus all accrued and unpaid interest thereon, and (B) the principal amount of Additional AIR Debentures to be prepaid, plus all other accrued and unpaid interest thereon, divided by the conversion price on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is less, multiplied by the daily volume weighted average price of the common stock on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is greater, and (ii) all other amounts, costs, expenses and liquidated damages due in respect of such Additional AIR Debentures. The interest rate on the Additional AIR Debentures will accrue at the rate of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, beginning five days after the occurrence of any Event of Default that results in the acceleration of the Additional AIR Debentures. A late fee of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, will accrue on a daily basis on all overdue accrued and unpaid interest under the Additional AIR Debentures from the due date to the date of payment.

The Additional AIR Warrants issued to the Investors on January 19, 2006 are initially exercisable into an aggregate of 3,809,524 shares of the Company’s common stock, and the initial exercise price of each Additional AIR Warrant is equal to $1.05 per share. The conversion price of the Additional AIR Debentures and the exercise price of the Additional AIR Warrants are each subject to an anti-dilution adjustment upon the issuance by us of securities at a price per share less than the then conversion price or exercise price, as applicable.

In addition, in consideration of each investor’s exercise of its Amendment No. 3 AIR, we granted to each investor further additional investment rights (each an “Amendment No. 4 AIR” and collectively, the “Amendment No. 4 AIRs”) pursuant to which each investor has the right to purchase detachable units consisting of (a) additional debentures in the principal amount of $1,000,000 with a conversion price of $1.25 per share (the “A4 Additional AIR Debentures”) and (b) additional warrants entitling the holder thereof to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A4 Additional AIR Debentures at a $1.25 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $1.25 per share (the “A4 Additional AIR Warrants”).

Under the terms of Amendment No. 4, we also agreed to register for resale the securities issuable upon conversion/exercise of the A4 Additional AIR Debentures and the A4 Additional AIR Warrants, consistent with the investors’ existing registration rights under the Registration Rights Agreement. We agreed to include such securities in the Registration Statement contemplated by Amendment No 3 which became effective on February 24, 2006.

Each investor was entitled exercise its A4 Additional AIR at any time on or after the 181st day after closing and on or prior to the earlier of (i) the close of business on the one-year anniversary after the registration statement for the shares of common stock underlying the A4 Additional AIR Debentures and A4 Additional AIR Warrants went effective and (ii) the two year anniversary of the closing of the transactions contemplated by Amendment No. 4.

In addition, in connection with the transactions contemplated by Amendment No. 4, the Company issued to a placement agent (i) 266,667 shares of common stock in lieu of a cash fee equal to 7% of the gross proceeds received by the Company, and (ii) warrants exercisable into approximately 120,000 shares of common stock at the same exercise price as the Additional AIR Warrants. These shares were also registered for resale in the registration statement which became effective on February 24, 2006.
 
 
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On January 23, 2006, we agreed with the four investors holding Additional AIR Warrants to amend the terms thereof, together with the terms of certain other warrants held by the investors in connection with the Securities Purchase Agreement (such other warrants and the Additional AIR Warrants are hereinafter collectively called the “Exercised Warrants”) to accelerate their exercise dates to January 23, 2006 in consideration of the full and immediate exercise thereof. These Exercised Warrants consisted of warrants for an aggregate of 2,439,024 shares issued in connection with Amendment No. 2 to the Securities Purchase Agreement (initially exercisable on March 8, 2006) and warrants for an aggregate of 4,878,048 shares issued in connection with Amendment No. 3 (initially exercisable beginning June 5, 2006). The investors agreed to immediately exercise 100% of these warrants (for aggregate gross proceeds to the Company of $6,000,000) in exchange for (a) the acceleration of the exercise period , and (b) the issuance of additional warrants equal to 50% of the Exercised Warrants (an aggregate of 3,658,536 shares) (the “January Inducement Warrants”). The January Inducement Warrants have an exercise price of $1.60 per share and will be exercisable for five years commencing on July 23, 2006. The exercise price is subject to an anti-dilution adjustment upon the issuance by us of securities at a price per share less than the then exercise price. If, at any time after the first anniversary of the date of issuance of the January Inducement Warrants, there is no effective registration statement registering for resale the shares of common stock into which the January Inducement Warrants are exercisable, each holder may exercise its January Inducement Warrant through a cashless exercise. The number of shares to be issued upon a cashless exercise will be equal to the quotient resulting from the following calculation: [(the volume weighted average price (VWAP) of our common stock on the trading day immediately preceding the date of such election less the exercise price, as adjusted) multiplied by the number of shares issuable upon exercise of the warrant by means of a cash exercise] divided by the VWAP on the trading day immediately preceding the date of such election. Each holder has agreed that it will not exercise its January Inducement Warrant if such exercise would cause the holder, together with its respective affiliates, to beneficially own more than 4.99% of our common stock then outstanding. The January Inducement Warrants and the shares of our common issuable upon the exercise thereof are included in the Registration Statement declared effected February 24, 2006.

Developments Subsequent to Fiscal Quarter Ended January 31, 2006

On February 27, 2006 the we and the fours investors under the Securities Purchase Agreement, Iroquois Capital LP (“Iroquois”), Cranshire, Smithfield Fiduciary LLC (“Smithfield”) and Omicron amended the terms of certain outstanding warrants to purchase common stock issued in connection with the Securities Purchase Agreements (the “February Exercised Warrants”) to accelerate their exercise date to February 27, 2006 in consideration of the full and immediate exercise thereof. These February Exercised Warrants consisted of warrants issued (i) to Omicron on July 22, 2005 for 243,902 shares of the Company’s common stock at $0.82 per share and then currently exercisable; (ii) to Cranshire on October 20, 2005 for 300,000 shares of the Company’s common stock at $1.20 per share (originally exercisable on April 20, 2006); (iii) to Iroquois on October 20, 2005 for 609,756 shares of the Company’s common stock at $1.20 per share (originally exercisable on April 20, 2006); (iv) to Cranshire on October 27, 2005 for 309,756 shares of the Company’s common stock at $1.25 per share (originally exercisable on April 27, 2006); (v) to Omicron and Smithfield on October 27, 2006 for 609,756 shares each of the Company’s common stock at $1.25 per share (originally exercisable on April 27, 2006); (vi) to each of the investors on October 27, 2005 for 304,878 shares each of the Company’s common stock at $1.25 per share (originally exercisable on April 27, 2006); (vii) to Cranshire on December 9, 2005 for 1,829,268 shares of the Company’s common stock at $1.25 per share (originally exercisable on June 9, 2006); and (viii) to each of the investors on January 20, 2006 for 952,381 shares each of the Company’s common stock at $1.05 per share (originally exercisable on July 20, 2006).

The investors agreed to immediately exercise 100% of the February Exercised Warrants (for aggregate gross proceeds to the Company of $11,014,267) in exchange for (a) the acceleration of the exercise periods and (b) the issuance of additional warrants equal to 50% of the February Exercised Warrants (an aggregate of 4,770,617 shares) (the “February Inducement Warrants”). The February Inducement Warrants have an exercise price of $3.00 per share and will be exercisable for five years commencing on August 27, 2006.
 
 
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Exercise of A4 Additional AIR

On February 28, 2006, we amended the terms of the A4 Additional AIRs previously granted to the investors in connection with Amendment No. 4 to accelerate the initial exercise date thereof to February 28, 2006 in consideration of the full and immediate exercise thereof by the investors.

In connection with the exercise of each A4Additional AIR, each investor purchased a $1,000,000 principal amount debenture with a conversion price of $1.25 (the “A4 AIR Debentures”) and warrants (the “A4 AIR Warrants”) entitling the investor to purchase a number of shares of the our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A4 AIR Debenture at a conversion price of $1.25 (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $1.25. Accordingly, we issued to the investors A4 AIR Debentures in the aggregate amount of $4,000,000 and A4 AIR Warrants to purchase an aggregate of 3,200,000 shares of our common stock, exercisable for five years commencing six months following the issuance thereof.

We received proceeds of approximately $4,000,000 in connection with the investors’ exercise of their A4 Additional AIRs.

The A4 AIR Debentures have a term of fifteen months and amortize over thirteen months in thirteen equal monthly installments beginning on the first day of the third month following their issuance. Interest on the principal amount outstanding accrues at a rate of 6% per annum. We may pay principal and accrued interest in cash or, at our option, in shares of our common stock. If the we elect to pay principal and interest in shares of our common stock, the value of each share of common stock will be equal to the lesser of (i) $1.25 and (ii) ninety percent (90%) of the average of the daily volume weighted average price for the common stock over the twenty trading day period immediately preceding the date of payment. At the option of the holder of each A4 AIR Debenture, the principal amount outstanding under each A4 AIR Debenture is initially convertible at any time after the closing of Amendment No 4 into shares of our common stock at a conversion price of $1.25.

Upon the occurrence of an “Event of Default,” including a default in payment of principal or interest (including late fees) which is not cured within three trading days, the full principal amount of each A4 AIR Debenture, together with interest and other amounts owing in respect thereof, to the date of acceleration will become, at the holder’s election, due and payable in cash. The aggregate amount payable upon an Event of Default will be equal to the “Mandatory Prepayment Amount.” The Mandatory Prepayment Amount for any A4 AIR Debentures will equal the sum of (i) the greater of: (A) 130% of the principal amount of A4 AIR Debentures to be prepaid, plus all accrued and unpaid interest thereon, or (B) the principal amount of A4 AIR Debentures to be prepaid, plus all other accrued and unpaid interest thereof, divided by the conversion price on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is less, multiplied by the daily volume weighted average price of the common stock on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is greater, and (ii) all other amounts, costs, expenses and liquidated damages due in respect of such A4 AIR Debentures. The interest rate on the A4 AIR Debentures will accrue at the rate of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, beginning five days after the occurrence of any Event of Default that results in the acceleration of the A4 AIR Debentures. A late fee of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, will accrue on a daily basis on all overdue accrued and unpaid interest under the A4 AIR Debentures from the due date to the date of payment.

The A4 AIR Warrants issued to the investors on February 28, 2006 are initially exercisable into an aggregate of 3,200,000 shares of the Company’s common stock, and the initial exercise price of each A4 AIR Warrant is equal to $1.25. The conversion price of the A4 AIR Debentures and the exercise price of the A4 AIR Warrants are each subject to an anti-dilution adjustment upon the issuance by us of securities at a price per share less than the then conversion price or exercise price, as applicable.
 
 
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In addition, in connection with the transactions contemplated by Amendment No. 4, the Company will pay a placement agent fee equal to 7% of the gross proceeds received by the Company ($280,000) and issue warrants exercisable into approximately 120,000 shares of common stock at the same exercise price as the A4 AIR Warrants.

On March 6, 2006, we agreed with the investors to amend the terms of A4 AIR Warrants to accelerate the exercise dates thereunder in respect of fifty percent (50%) of the shares of our common stock issuable thereunder (an aggregate of 1,600,000 shares) to March 6, 2006. The A4 AIR Warrants were initially exercisable on August 31, 2006. The investors agreed to immediately exercise fifty percent (50%) of the A4 AIR Warrants (for aggregate gross proceeds to the Company of $2,000,000) in exchange for (a) the acceleration of the exercise period (insofar as it applied to fifty percent (50%) of the stock issuable thereunder, and (b) the issuance of additional warrants equal to 50% of the exercised A4 AIR Warrants (an aggregate of 800,000 shares). The new warrants have an exercise price of $3.00 per share and will be exercisable for five years from September 6, 2006.


Results of Operations
Three and Six Months Ended January 31, 2006 Compared to Three and Six Months Ended January 31, 2005

Our net loss for the quarter ended January 31, 2006 was $14,400,597 versus $6,301,182 in the corresponding quarter of the prior fiscal year. The increase in net loss in this fiscal quarter versus the corresponding quarter of the prior fiscal year is primarily due to an increase in interest expense incurred in connection with convertible debentures. Our operating loss for the quarter decreased to $ 5,184,252 compared to $5,555,641 in the second fiscal quarter of 2005. The decrease is a result of the lower research and development expenses ($1,317,115 versus $2,181,835 last year) despite a moderate increase in our general and administrative expenses (to $3,910,887 from $3,450,556) and lower revenue received this quarter ($43,750) versus the same quarter of last year ($76,750).

The decrease in research and development expenses for the fiscal quarter ending January 31, 2006 reflects a decreased level of research and development activities in respect of our buccal delivery technologies and Antigen Express research and development activities. Expenses in the second fiscal quarter of 2005 also reflected increased activities of regulatory consultants that were much lower this quarter.

The increase in general and administrative expenses for the second fiscal quarter of 2006 is primarily attributable to a $2,000,000 bonus payment to company executives as compensation despite a significant decrease in financial and consulting services, lower legal costs and a reduction in travel expenses.

Our interest expense in the second fiscal quarter of 2006 increased to $8,490,956 compared to interest expense of $773,602 in the second fiscal quarter of 2005 due to interest paid in connection with convertible debentures entered during last fiscal year and current quarter and interest expense associated with the value of warrants issued to convertible debenture holders as an incentive to exercise their existing warrants. Our interest and income from rental operations increased to $45,746 in the second fiscal quarter of 2006 compared to $28,061 in the same quarter last year due to the reallocation of certain properties to rental operations and higher interest earned on short term investments. In addition, this fiscal quarter we incurred $771,635 in losses on extinguishment of debt in connection with monthly amortization payments due on convertible debentures which amount represents the difference between the quoted market price of our stock and a 10% discount to the average of the 20-day VWAP that was used to determine the number of shares issued.


Financial Condition, Liquidity and Resources

To date we have financed our development stage activities primarily through private placements of our common stock and securities convertible into our common stock.
 
 
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During the six months ended January 31, 2006, we engaged in several capital-raising transactions with certain of our stockholders as described below and above under the caption Developments in Fiscal Quarter Ended January 31, 2006 in this Part I - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations, and as described in our Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2005. At January 31, 2006, we had cash and short-term investments of approximately $21.6 million, an increase of approximately 21 million from the balance as of the end of the prior fiscal year. The increase is attributable to the proceeds received in connection with warrant and additional investment right exercises during the first two quarters of our fiscal 2006. At January 31, 2006, we believed that our anticipated cash position was sufficient to meet our working capital needs for the next 12 months based on the pace of our planned activities. Beyond that, we will likely require additional funds to support our working capital requirements or for other purposes. From time to time as deemed appropriate by management, we may seek to raise funds through private or public equity financing or from other sources. If we are unable to raise additional capital as needed, we could be required to "scale back" or otherwise revise our business plan. Any significant scale back of operations or modification of our business plan due to a lack of funding could be expected to affect our prospects materially and adversely.

At January 31, 2006, we had 6% Secured Convertible Debentures (the “Debentures”) outstanding in the aggregate principal amount of $5,384,615, which were issued in connection with the Securities Purchase Agreement and the amendments thereto. At such date, we had issued an aggregate of 9,822,145 shares of common stock resulting from the conversion of an aggregate of $7,643,960 of Debenture principal and accrued interest issued under the auspices of the Securities Purchase Agreement, as amended.

At January 31, 2006, we had additional investment rights granted in connection with Amendment No. 4 outstanding pursuant to which the holders of the Debentures had the right to purchase additional Debentures in the aggregate principal amount of $4,000,000 and related warrants to purchase an aggregate of 3,200,000 shares of our common stock (which additional investment rights were subsequently fully exercised).

Securities Purchase Agreement

We entered into the Securities Purchase Agreement on November 10, 2004 and closed the transaction on November 12, 2004. Pursuant to the Securities Purchase Agreement, we issued Debentures and related warrants and for an aggregate purchase price of $4,000,000, which Debentures have since been fully repaid in cash or by conversion into shares of our common stock. The warrants issued in connection with the Securities Purchase Agreement were initially exercisable into the same number of shares of the common stock initially issuable upon conversion of the Debentures. The initial exercise price of each warrant was equal to 110% of the conversion price of the Debentures, or $0.91. The conversion price of the Debentures and the exercise price of the warrants were each subject to an anti-dilution adjustment upon the issuance by us of securities at a price per share less than the then conversion price or exercise price, as applicable. The warrants issued in connection with the Securities Purchase Agreement were fully exercised in late October 2005 as described below under the caption Exercise of Outstanding Warrants Issued Pursuant to Securities Purchase Agreement at a reduced exercise price $0.82 per share as a consequence of an anti-dilution adjustment.

In connection with the Securities Purchase Agreement, we granted an Additional Investment Right to holders of the Debentures. Pursuant to the terms of each Additional Investment Right, each holder had the right at any time prior to January 24, 2006 to purchase on the same terms and conditions as the private placement up to the same number of Debentures and warrants purchased by such holder at the closing of the private placement.

In connection with the Securities Purchase Agreement, we also issued to a placement agent a warrant exercisable into approximately 145,000 shares of common stock at the same exercise price as the warrants issued to the holders of the Debentures.

The aggregate number of shares of common stock issuable upon conversion or exercise of the Debentures and related warrants issuable pursuant to the Securities Purchase Agreement exceeded 19.99% of the outstanding shares of our common stock prior to such issuance. Because the rules and regulations of The Nasdaq Stock Market prohibit, under certain circumstances, the issuance, without prior stockholder approval, of shares of common stock in excess of 19.99% of an issuer's outstanding common stock prior to such issuance, certain insiders entered into a voting agreement with the holders of the Debentures whereby such insiders agreed to vote at the next meeting of our stockholders all shares of common stock held by them in favor of authorizing the issuance of an amount of shares of common stock in excess of 19.99% of the outstanding common stock prior to consummating the private placement. The issuance of such shares was approved by our stockholders at the Annual Meeting of Stockholders held on April 5, 2005.
 
 
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AIR Exercise Pursuant to Amendment No. 1

On June 16, 2005, we and each of the four accredited investor parties to the Securities Purchase Agreement entered into Amendment No. 1 to the Securities Purchase Agreement and the Registration Rights Agreement (“Amendment No. 1”), pursuant to which the investors agreed to exercise of 50% of their additional investment rights in the aggregate amount of $2,000,000. This transaction closed on June 17, 2005. In consideration for the investors’ exercise of their additional investment rights (the “A1 Air Exercise”), we issued the investors:

 
Ÿ
Debentures in the aggregate amount of $2,000,000, with a reduced conversion price ($0.60) (which reduced conversion price did not trigger any anti-dilution adjustments to the outstanding Debentures and related warrants) (the “A1 AIR Debentures”);

 
Ÿ
warrants to purchase an aggregate of 2,439,024 shares of our common stock at an exercise price of $0.82 per share, which were exercisable for five years commencing six months following the issuance thereof (the “A1 AIR Warrants”); and

 
Ÿ
further additional investment rights (“A1 Additional AIRs”), pursuant to which each investor had the right to purchase detachable units consisting of (i) Debentures in principal amount equal to the principal amount of A1 AIR Debentures issuable to each investor upon the A1 AIR Exercise with a conversion price of $0.82 (the “A1 Additional AIR Debentures”) and (ii) additional warrants entitling the holder thereof to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A1 Additional AIR Debentures at an $0.82 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $0.82 (the “A1 Additional AIR Warrants”).

The A1 AIR Debentures have since been fully converted into shares of our common stock. The A1 AIR Warrants were amended (to abridge the exercise periods) and exercised in full in late October 2005 as described below under the caption Exercise of Outstanding AIR Warrants. The AI Additional AIRs were amended (to abridge the exercise periods) and exercised in full in December 2005 as described below under Omicron’s Exercise of Additional AIR and Third AIR Exercise Pursuant to Amendment No. 3.

In addition, in connection with the transactions contemplated by Amendment No. 1, we issued to a placement agent (i) 170,732 shares of common stock in lieu of a cash fee equal to 7% of the gross proceeds received by us and (ii) warrants exercisable into approximately 60,000 shares of our common stock at the same exercise price as the A1 AIR Warrants.
As we obtained shareholder approval at our April 5, 2005 Annual Meeting of Stockholders for the issuance of up to an aggregate of 10,000,000 shares of common stock or securities convertible into common stock for a price of not less than 70% of the market price at the time of issuance and for aggregate consideration not to exceed $50,000,000, in excess of the number of shares that NASDAQ’s Marketplace Rules 4350(i)(1)(c) and (D) permit us to issue without prior stockholder approval, no further stockholder approval was necessary in connection with the transactions contemplated by Amendment No. 1.
 
 
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Second AIR Exercise Pursuant to Amendment No. 2

On September 8, 2005, we and the investor parties to the Securities Purchase Agreement entered into Amendment No. 2 pursuant to which the investors agreed to exercise the remaining $2,000,000 in principal amount of their original additional investment rights acquired pursuant to the Securities Purchase Agreement on November 12, 2004 (the “A2 AIR Exercise”). In connection with the A2 AIR Exercise, we issued the investors:

 
Ÿ
Debentures in the aggregate amount of $2,000,000, with a reduced conversion price ($0.60) (which reduced conversion price did not trigger any anti-dilution adjustments to the outstanding Debentures and related warrants) (the “A2 AIR Debentures”);

 
Ÿ
warrants to purchase an aggregate of 2,439,024 shares of our common stock at the exercise price of $0.82 per share, which were exercisable for five years commencing six months following the issuance thereof (the “A2 AIR Warrants”); and

 
Ÿ
additional investment rights (the “A2 Additional AIRs”), pursuant to which each investor had the right to purchase detachable units consisting of (i) Debentures in principal amount equal to the principal amount of A2 AIR Debentures issuable to each investor upon the A2 AIR Exercise with a conversion price of $0.82 (the “A2 Additional AIR Debentures”) and (ii) additional warrants entitling the holder thereof to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A2 Additional AIR Debentures at an $0.82 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $0.82.

With the exception of A2 AIR Debenture held by Omicron, the A2 AIR Debentures have since been fully converted into shares of our common stock. The A2 AIR Debentures have a term of fifteen months and amortize over thirteen months in thirteen equal monthly installments beginning on the first day of the third month following their issuance. Interest on the principal amount outstanding accrues at a rate of 6% per annum. We may pay principal and accrued interest in cash or, at our option, in shares of our common stock. If we elect to pay principal and interest in shares of our common stock, the value of each share of common stock will be equal to the lesser of (i) the conversion price ($0.60) and (ii) ninety percent (90%) of the average of the daily volume weighted average price for the common stock for the twenty trading day period immediately preceding the date of payment. At the option of the holder of each A2 AIR Debenture, the principal amount outstanding under each A2 AIR Debenture is convertible at any time into shares of our common stock at a conversion price of $0.60.

Upon the occurrence of an “Event of Default,” including a default in payment of principal or interest (including late fees) which is not cured within three trading days, the full principal amount of each A2 AIR Debenture, together with interest and other amounts owing in respect thereof, to the date of acceleration will become, at the holder’s election, due and payable in cash. The aggregate amount payable upon an Event of Default shall be equal to the “Mandatory Prepayment Amount.” The Mandatory Prepayment Amount for any A2 AIR Debentures shall equal the sum of (i) the greater of: (A) 130% of the principal amount of A2 AIR Debentures to be prepaid, plus all accrued and unpaid interest thereon, or (B) the principal amount of A2 AIR Debentures to be prepaid, plus all other accrued and unpaid interest thereof, divided by the conversion price on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is less, multiplied by the daily volume weighted average price of the common stock on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is greater, and (ii) all other amounts, costs, expenses and liquidated damages due in respect of such Second AIR Debentures. The interest rate on the A2 AIR Debentures will accrue at the rate of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, beginning five days after the occurrence of any Event of Default that results in the acceleration of the A2 AIR Debentures. A late fee of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, will accrue on a daily basis on all overdue accrued and unpaid interest under the A2 AIR Debentures from the due date to the date of payment.
 
 
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The A2 AIR Warrants were amended (to abridge the exercise periods) and exercised in full in late October 2005 as described below under the caption Exercise of Outstanding AIR Warrants. The A2 Additional AIRs were amended (to abridge the exercise periods) and exercised in full in December 2005 as described below under Omicron’s Exercise of Additional AIR and Third AIR Exercise Pursuant to Amendment No. 3.


In addition, in connection with the transactions contemplated Amendment No. 2, we issued to a placement agent (i) 170,732 shares of our common stock in lieu of a cash fee equal to 7% of the gross proceeds received by us and (ii) warrants exercisable into approximately 60,000 shares of our common stock at the same exercise price as the Second AIR Warrants.

Cranshire and Omicron Notes and Related Warrants

We entered into a Promissory Note and Agreement with Cranshire on March 28, 2005 and entered into a Promissory Note and Agreement with Omicron on April 6, 2005 pursuant to which Cranshire and Omicron loaned us the principal amounts of $500,000 and $100,000, respectively (the "Notes"). The outstanding principal balances under the Notes and any accrued but unpaid interest thereon was due and payable on May 15, 2005 to the extent that Cranshire and Omicron had not exercised their respective conversion rights under the Notes as described below. The Notes were subordinate to our obligations under the Debentures. We were obligated to use a portion of the proceeds received from Cranshire to pay two of the holders (not including Cranshire or Omicron) of the Debentures the full amount of the March 1, 2005 monthly amortization payments due under the Debentures.

On April 28, 2005, as additional consideration for the loans from Cranshire and Omicron, we issued Cranshire a warrant to purchase an aggregate of 1,219,512 shares of our common stock at a per share price of $0.82 and issued Omicron a warrant to purchase an aggregate of 243,902 shares of our common stock at a per share price of $0.82. At the holders’ option, the outstanding principal balance under the Notes, together with any accrued but unpaid interest thereon, were convertible into shares of our common stock at the conversion/exercise price of $0.82 per share.

We did not pay the outstanding principal balances originally due on May 15, 2005 under the Notes. Interest on the outstanding principal balances under the Notes began accruing before the maturity date at the rate of 10% per annum. On June 7, 2005, Cranshire and Omicron agreed to extend the interest payment date and the maturity date of each of the Notes from May 15, 2005 to July 22, 2005. In consideration for the foregoing extension, we contemporaneously issued Cranshire a warrant to purchase an aggregate of 1,219,512 shares of our common stock at a per share price of $0.82 and issued Omicron a warrant to purchase an aggregate of 243,902 shares of our common stock at a per share price of $0.82

On July 22, 2005, Cranshire and Omicron agreed to extend the interest payment date and the maturity date under the Notes from July 22, 2005 to September 20, 2005. As consideration for the extensions from Cranshire and Omicron, we contemporaneously issued on a warrant to Cranshire to purchase an aggregate of 1,219,512 shares of our common stock at a per share price of $0.82 and a warrant to Omicron to purchase an aggregate of 243,902 shares of our common stock at a per share price of $0.82.

On September 20, 2005, we did not pay the outstanding principal balances under the Notes. On October 19, 2005 Cranshire converted outstanding principal and accrued interest on its Note ($528,082 in total) into 644,003 shares of our common stock. On October 27, 2005 Omicron converted outstanding principal and accrued interest on its Note ($105,644 in total) into 128,834 shares of common stock.

In October and November 2005, Cranshire exercised the outstanding warrants previously issued to it in connection with its Note in respect of which we received aggregate proceeds of approximately $3,000,000. On December 9, 2005, in consideration of such exercises, we issued to Cranshire a five-year warrant to purchase an aggregate of 1,829,268 shares of our common stock at $1.25 per share. On February 28, 2006, Omicron exercised one of its warrants previously issued to it in connection with its Note pursuant to which it purchased an aggregate of 243,902 shares of our common stock for $200,000. In consideration of such exercise, we issued to Omicron a five-year warrant to purchase an aggregate of 121,951 shares of our common stock at $3 per share. Prior thereto, Omicron has voluntarily exercised all of its other warrants previously issued to it in connection with its Note for no additional consideration.
 
 
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Assistance Agreement with Eckert Seamans

On March 30, 2005, we entered into an Assistance Agreement with Eckert Seamans, pursuant to which Eckert Seamans advanced us funds in the amount of $325,179 for the sole purpose of making the interest payment and the monthly redemption payment due on March 31, 2005 and April 1, 2005, respectively, under the Debentures. Under the terms of the Assistance Agreement, we agreed to repay such advance without interest in three equal installments due on October 1, 2005, November 1, 2005 and December 1, 2005. We have not paid any of the installments due under the Assistance Agreement. Because we did not make the first installment payment on October 1, 2005 as of that date, all amounts owed to Eckert Seamans became payable on demand, and interest on such unpaid amounts began accruing at the rate of 8% per annum. Attached financial statements reflect interest accrual on this advance as of January 31, 2006. We are currently in negotiations with Eckert Seamans and are seeking to extend the payment dates or to pay the outstanding balance with shares of our common stock. The total interest arrearage to date under the Assistance Agreement is approximately $22,190.

Exercise of Outstanding Warrants Issued Pursuant to Securities Purchase Agreement

On October 20, 2005, in consideration for the exercise of certain outstanding warrants previously issued to each of Cranshire and Iroquois in connection with their purchase of our Debentures pursuant to the Securities Purchase Agreement, we issued a five-year warrant to purchase 300,000 shares of our common stock to Cranshire and a five-year warrant to purchase 609,756 shares of our common stock to Iroquois, in each case with an exercise price of $1.20 per share. We received aggregate proceeds of $1,492,000 in connection with Cranshire’s partial exercise of its outstanding warrant to purchase 1,219,512 shares of our common stock and Iroquois’ full exercise of its outstanding warrant to purchase 1,219,512 shares of our common stock.

On October 27, 2005, in consideration for the exercise of certain outstanding warrants previously issued pursuant to the Securities Purchase Agreement, we issued to Cranshire, Omicron and Smithfield five-year warrants to purchase an aggregate of 1,529,268 shares of our common stock at $1.25 per share. We received aggregate proceeds of approximately $2,508,000 in connection with their exercise of outstanding warrants to purchase shares of our common stock.

Exercise of Outstanding AIR Warrants

On October 26, 2005, we and the holders of the A1 AIR Warrants amended the A1 AIR Warrants pursuant to which we agreed to accelerate the initial exercise dates thereof (the 181st day following the date of issuance) in consideration of the full and immediate exercise by each of the investors of its A1 AIR Warrant and the delivery to us of a Notice of Exercise in respect thereof on or before the close of business on October 27, 2005. Each of the investors timely delivered the aforementioned Notice of Exercise, satisfying the conditions specified in each of the A1 AIR Warrant amendments. We received aggregate proceeds of approximately $2,000,000 in connection with the investors’ exercise of the A1 AIR Warrants. In consideration of the investors’ exercise of the A1 AIR Warrants, we issued each of the investors a five-year warrant to purchase 304,878 shares of our common stock at $1.25 per share.

Omicron’s Exercise of Additional AIR

On October 27, 2005, we and Omicron amended the A1 Additional AIR granted to Omicron to accelerate the initial exercise date (defined as the 181st day following the date of issuance) in consideration of the full and immediate exercise by Omicron of its A1 Additional AIR and the delivery to us of a Notice of Exercise in respect thereof on or before the close of business on October 27, 2005. Omicron timely delivered its Notice of Exercise, satisfying the conditions specified in the A1 AIR amendment. In connection with Omicron’s exercise of the A1 Additional AIR, we received aggregate proceeds of $500,000. Through its exercise of its A1 Additional AIR, Omicron purchased (i) a $500,000 principal amount A1 Additional AIR Debenture with a conversion price of $0.82 and (ii) A1 Additional AIR Warrants entitling Omicron to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A1 Additional AIR Debenture at a $0.82 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $0.82
 
 
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Third AIR Exercise Pursuant to Amendment No. 3

On December 4, 2005, we and the four accredited investor parties to the Securities Purchase Agreement entered into Amendment No. 3 pursuant to which (i) the all of the investors except Omicron agreed to exercise an aggregate of $1,500,000 in principal amount of the A1 Additional AIRs (Omicron had previously exercised its A1 Additional AIR as described above), and (ii) all of the investors, including Omicron, agreed to exercise an aggregate of $2,000,000 in principal amount of the A2 Additional AIRs granted to them in connection with Amendment No. 2.

In connection with Amendment No. 3, we and the investors, excluding Omicron, agreed to accelerate the initial exercise date of the A1 Additional AIRs (the 181st day following the date of issuance) in consideration of the full and immediate exercise by such investors of their A1 Additional AIRs and the delivery to us of Notices of Exercise in respect thereof on or before the close of business on December 5, 2005. In addition, we and all four of the investors agreed to accelerate the initial exercise dates of the A2 Additional AIRs (the 181st day following the date of issuance) in consideration of the full and immediate exercise by the investors of their A2 Additional AIRs and the delivery to us of Notices of Exercise in respect thereof on or before the close of business on December 5, 2005.

Each investor timely delivered its Notices of Exercise In connection with the exercise of each A1 Additional AIR and each A2 Additional AIR on December 5, 2005, each investor purchased a $500,000 principal amount Debenture with a conversion price of $0.82 (the A1 Additional Debentures and the A2 Additional Debentures) and a Warrant entitling the investor to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A1 Additional AIR Debenture and the A2 Additional AIR Debenture (together, the “A1/A2 Additional AIR Debentures”) at a $0.82 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $0.82 per share (the A1 Additional AIR Warrants and the A2 Additional AIR Warrants (together, the “A1/A2 Additional AIR Warrants”)). Accordingly, we issued to the investors A1/A2 Additional AIR Debentures in the aggregate principal amount of $3,500,000 and A1/A2 Additional AIR Warrants to purchase an aggregate of 4,268,292 shares of our common stock, exercisable for five years commencing six months following the issuance thereof. We received proceeds of approximately $3,500,000 in connection with the investors’ exercise of their A1 Additional AIRs and their A2 Additional AIRS.

With the exception of the A1/Ad Additional AIR Debenture held by Omicron, the A1/A2 Additional AIR Debentures have since been fully converted into shares of our common stock. The A1/A2 Additional AIR Debentures have a term of fifteen months and amortize over thirteen months in thirteen equal monthly installments beginning on the first day of the third month following their issuance. Interest on the principal amount outstanding accrues at a rate of 6% per annum. We may pay principal and accrued interest in cash or, at our option, in shares of our common stock. If we elect to pay principal and interest in shares of our common stock, the value of each share of common stock will be equal to the lesser of (i) $0.82 and (ii) ninety percent (90%) of the average of the daily volume weighted average price for the common stock over the twenty trading day period immediately preceding the date of payment. At the option of the holder of each A1/A2 Additional AIR Debenture, the principal amount outstanding under each A1/A2 Additional AIR Debenture is convertible at any time into shares of our common stock at a conversion price of $0.82.

Upon the occurrence of an “Event of Default,” including a default in payment of principal or interest (including late fees) which is not cured within three trading days, the full principal amount of each A1/A2 Additional AIR Debenture, together with interest and other amounts owing in respect thereof, to the date of acceleration will become, at the holder’s election, due and payable in cash. The aggregate amount payable upon an Event of Default shall be equal to the “Mandatory Prepayment Amount.” The Mandatory Prepayment Amount for any A1/A2 Additional AIR Debentures shall equal the sum of (i) the greater of: (A) 130% of the principal amount of A1/A2 Additional AIR Debentures to be prepaid, plus all accrued and unpaid interest thereon, or (B) the principal amount of A1/A2 Additional AIR Debentures to be prepaid, plus all other accrued and unpaid interest thereof, divided by the conversion price on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is less, multiplied by the daily volume weighted average price of the common stock on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is greater, and (ii) all other amounts, costs, expenses and liquidated damages due in respect of such A1/A2 Additional AIR Debentures. The interest rate on the A1/A2 Additional AIR Debentures will accrue at the rate of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, beginning five days after the occurrence of any Event of Default that results in the acceleration of the A1/A2 Additional AIR Debentures. A late fee of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, will accrue on a daily basis on all overdue accrued and unpaid interest under the A1/A2 Additional AIR Debentures from the due date to the date of payment.

 
40

 

In addition, in consideration of each investor’s exercise of its A1 Additional AIRs and its A2 Additional AIRs, including Omicron’s October 2005 exercise of its A1 Additional AIR, we granted to each investor an additional investment right (the “A3 Additional AIRs”) pursuant to which each investor had the right to purchase detachable units consisting of (a) Debentures in principal amount of $1,000,000 with a conversion price of $1.25 per share (the “A3 Additional AIR Debentures”) and (b) warrants entitling the holder thereof to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A3 Additional AIR Debentures at a $1.25 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $1.25 per share.

In addition, in connection with the transactions contemplated by Amendment No. 3 and Omicron’s October 2005 exercise of its A1 Additional AIR, we paid to a placement agent (i) 224,000 shares of our common stock in lieu of a $280,000 cash fee (7% of the gross proceeds received by us) and (ii) warrants exercisable into 105,000 shares of common stock at the same exercise price as the A1/A2 Additional AIR Warrants. These shares were also registered for resale.

The A1/A2 Additional AIR Warrants were amended (to abridge the exercise periods) and exercised in full in late December 2005 as described below under the caption January 2006 Acceleration and Exercise of AIR Warrants. The A3 Additional AIRs were amended (to abridge the exercise periods) and exercised in full in December 2005 as described below under Fourth AIR Exercise Pursuant to Amendment No. 4.

Exercise of Warrants in December 2005.

On December 9, 2005, in consideration for the exercise of certain outstanding warrants previously issued in connection with its Note, we issued to Cranshire five-year warrants to purchase an aggregate of 1,829,268 shares of our common stock at $1.25 per share. We received aggregate proceeds of approximately $3,000,000 in connection with the warrant exercise

Fourth AIR Exercise Pursuant to Amendment No. 4

On January 19, 2006, we and each of the investors entered into Amendment No. 4 to the Securities Purchase Agreement and Registration Rights Agreement (“Amendment No. 4”), pursuant to which the investors agreed to exercise an aggregate of $4,000,000 in principal amount of the A3 Additional AIRs (being the full amount thereof). Pursuant to each such A3 Additional AIR, each Investor had the right to purchase detachable units consisting of (a) an A3 Additional AIR Debenture in principal amount of $1,000,000 with a conversion price of $1.25 and (b) an A3 Additional AIR Warrant entitling the holder thereof to purchase a number of shares of the Company’s common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A3 additional AIR Debenture at a $1.25 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $1.25 per share.
 
 
41


 
Pursuant to Amendment No. 4, we amended the terms of the A3 Additional AIRs to accelerate the initial exercise dates thereof to January 19, 2006 and to reduce the conversion price from $1.25 to $1.05 in consideration of their full and immediate exercise by the investors.

Accordingly, we issued to the investors A3 Additional AIR Debentures in the aggregate amount of $4,000,000 and A3 Additional AIR Warrants to purchase an aggregate of 3,809,524 shares of our common stock, exercisable for five years commencing six months following the issuance thereof. Under the terms of Amendment No. 4, the reduction in the conversion price of the A3 Additional AIR Debentures and the exercise price of the A3 Additional AIR Warrants did not trigger any anti-dilution adjustments to any outstanding securities held by the investors.

We received proceeds of approximately $4,000,000 in connection with the investors’ exercise of their A3 Additional AIRs.

With the exception of of the A3 Additional AIR Debenture held by Omicron, the A3 Additional AIR Debentures have since been fully converted into shares of our common stock. The A3 Additional AIR Debentures have a term of fifteen months and amortize over thirteen months in thirteen equal monthly installments beginning on the first day of the third month following their issuance. Interest on the principal amount outstanding accrues at a rate of 6% per annum. We may pay principal and accrued interest in cash or, at our option, in shares of our common stock. If the we elect to pay principal and interest in shares of our common stock, the value of each share of common stock will be equal to the lesser of (i) $1.05 and (ii) ninety percent (90%) of the average of the daily volume weighted average price for the common stock over the twenty trading day period immediately preceding the date of payment. At the option of the holder of each A3 Additional AIR Debenture, the principal amount outstanding under each A3 AdditionalAIR Debenture is convertible at any time into shares of the our common stock at a conversion price of $1.05.

Upon the occurrence of an “Event of Default,” including a default in payment of principal or interest (including late fees) which is not cured within three trading days, the full principal amount of each A3 Additional AIR Debenture, together with interest and other amounts owing in respect thereof, to the date of acceleration will become, at the holder’s election, due and payable in cash. The aggregate amount payable upon an Event of Default shall be equal to the “Mandatory Prepayment Amount.” The Mandatory Prepayment Amount for any A3 Additional AIR Debentures shall equal the sum of (i) the greater of: (A) 130% of the principal amount of A3 Additional AIR Debentures to be prepaid, plus all accrued and unpaid interest thereon, or (B) the principal amount of A3 Additional AIR Debentures to be prepaid, plus all other accrued and unpaid interest thereof, divided by the conversion price on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is less, multiplied by the daily volume weighted average price of the common stock on (x) the date the Mandatory Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory Prepayment Amount is paid in full, whichever is greater, and (ii) all other amounts, costs, expenses and liquidated damages due in respect of such A3 Additional AIR Debentures. The interest rate on the A3 Additional AIR Debentures will accrue at the rate of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, beginning five days after the occurrence of any Event of Default that results in the acceleration of the A3 Additional AIR Debentures. A late fee of 18% per annum, or such lower maximum amount of interest permitted to be charged under applicable law, will accrue on a daily basis on all overdue accrued and unpaid interest under the A3 Additional AIR Debentures from the due date to the date of payment. The conversion price of the A3 Additional AIR Debentures is subject to an anti-dilution adjustment upon the issuance by us of securities at a price per share less than the then conversion price.

In addition, in consideration of each investor’s exercise of its A3 Additional AIR, we granted to each investor a further additional investment right (the “A4 Additional AIR”) pursuant to which each investor had the right to purchase detachable units consisting of (a) a Debenture in principal amount of $1,000,000 with a conversion price of $1.25 (the “A4 Additional AIR Debenture” and (b) a warrant entitling the holder thereof to purchase a number of shares of our common stock equal to 100% of the shares of common stock issuable upon the conversion in full of the A4 Additional AIR Debenture at a $1.25 conversion price (subject to adjustment as set forth therein) (without regard to any restrictions on conversion therein contained) at an exercise price of $1.25 per share (the “A4 Additional AIR Warrants”).
 
 
42


 
Under the terms of Amendment No. 4, we also agreed to register for resale the securities issuable upon conversion/exercise of the A4 Additional AIR Debentures and the A4 Additional AIR Warrants, consistent with the investors’ existing registration rights under the Registration Rights Agreement. We agreed to register such securities on the Registration Statement contemplated by Amendment No. 3. The Registration Statement became effective on February 24, 2006.

In addition, in connection with the transactions contemplated by Amendment No. 4, the Company issued to a placement agent (i) 266,667 shares of common stock in lieu of a cash fee equal to 7% of the gross proceeds received by the Company and (ii) warrants exercisable into approximately 120,000 shares of common stock at the same exercise price as the AIR Warrants. These shares were registered for resale in the registration statement which became effective on February 24, 2006.

January 2006 Acceleration and Exercise of AIR Warrants

On January 23, 2006, we agreed with the investors to amend the terms of certain outstanding warrants to purchase common stock (“January Exercise Warrants”) to accelerate their exercise dates to January 23, 2006. The January Exercise Warrants consisted of warrants for an aggregate of 2,439,024 shares issued in connection with Amendment No. 2 (initially exercisable on March 8, 2006) and warrants for an aggregate of 4,878,048 shares issued in connection with Amendment No. 3 (initially exercisable beginning June 5, 2006). The investors agreed to immediately exercise 100% of these warrants (for aggregate gross proceeds to the Company of $6,000,000) in exchange for (a) the acceleration of the exercise period , and (b) the issuance of additional warrants equal to 50% of the shares issuable upon exercise of the January Exercise Warrants (an aggregate of 3,658,536 shares) (the “January Inducement Warrants”). The January Inducement Warrants have an exercise price of $1.60 per share and will be exercisable for a period of five years commencing six months from the date of issuance. The exercise price is subject to an anti-dilution adjustment upon the issuance by us of securities at a price per share less than the then exercise price. If, at any time after the first anniversary of the date of issuance of the January Inducement Warrants, there is no effective registration statement registering for resale the shares of common stock into which the warrants are exercisable, each holder may exercise its warrant through a cashless exercise. The January Inducement Warrants are included in a Registration Statement declared effective February 24, 2006. The number of shares to be issued upon a cashless exercise will be equal to the quotient resulting from the following calculation: [(the VWAP on the trading day immediately preceding the date of such election less the exercise price, as adjusted) multiplied by the number of shares issuable upon exercise of the warrant by means of a cash exercise] divided by the VWAP on the trading day immediately preceding the date of such election. Each holder has agreed that it will not exercise its warrant if such exercise would cause the holder, together with its respective affiliates, to beneficially own more than 4.99% of our common stock then outstanding.

In the past, we have funded most of our development and other costs with equity financing. While we have been able to raise equity capital as required, unforeseen problems with our clinical program or materially negative developments in general economic conditions could interfere with our ability to raise additional equity capital as needed, or materially adversely affect the terms upon which such capital is available.

Going Concern Uncertainty

In their audit opinion issued in connection with our consolidated balance sheet as of July 31, 2005 and our consolidated statements of operation, stockholders’ equity and cash flows for the year then ended and for the period from November 2, 1995 (date of inception) to July 31, 2005, our auditors expressed substantial doubt about our ability to continue as a going concern given our recurring net losses, negative cash flows from operations and working capital deficiency.
 
 
43


 
The accompanying financial 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. We have experienced negative cash flows from operations since inception and had an accumulated deficit at January 31, 2006 of approximately $143,931,923. We have funded our activities to date almost exclusively from debt and equity financings.

We are in the development stage and have realized minimal revenues to date. We will continue to require substantial funds to continue research and development, including preclinical studies and clinical trials of our product candidates, and to commence sales and marketing efforts, if the FDA or other regulatory approvals are obtained. Management’s plans in order to meet our operating cash flow requirements include financing activities such as private placements of our common stock, preferred stock offerings, debt and convertible debt instruments. Management is also actively pursuing industry collaboration activities, including product licensing and specific project financing.

While we believe that we will be successful in obtaining the necessary financing to fund our operations, there are no assurances that such additional funding will be achieved and that we will succeed in our future operations. The financial 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 we be unable to continue in existence.

Critical Accounting Policies

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

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:

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 Statement of Financial Accounting Standards No. 144, "Accounting for the Impairment or Disposal 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.

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.

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.

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 the Company does not have any non-consolidated special purpose entities.
 
 
44


 
Contractual Obligations

Payments Due by Period
Contractual Obligations
Total
Less than 1
year
1-3 years
3-5 years
More than
5 years
Long-Term Debt Obligations
9,515,722
8,921,973
593,749
0
0
Capital Lease Obligations
0
0
0
0
0
Operating Lease Obligations
61,755
21,626
30,956
9,173
0
Purchase Obligations
0
0
0
0
0
Other Long-Term Liabilities Reflected on the
Registrant's Balance Sheet under GAAP
0
0
0
0
0
Total
$9,577,477
$8,943,599
$624,705
$9,173
$0

Related Party Transactions

Prior to January 1, 1999, a portion of our general and administrative expenses resulted from transactions with affiliated persons, and a number of capital transactions also involved affiliated persons. Although these transactions were not the result of "arms-length" negotiations, we do not believe that this fact had a material impact on our results of operations or financial position. Prior to December 31, 1998, we classified certain payments to executive officers for compensation and expense reimbursements as "Research and Development - related party" and "General and Administrative - related party" because the executive officers received such payments through personal services corporations rather than directly. After December 31, 1998, these payments have been and will continue to be accounted for as though the payments were made directly to the officers, and not as a related party transaction. With the exception of our arrangement with our management company described below, we do not foresee a need for, and therefore do not anticipate, any related party transactions in the current fiscal year.

We utilize a management company to manage all of our real properties. The property management company is owned by Anna Gluskin, Rose Perri, our Chief Operating Officer, Chief Financial Officer, Treasurer and Secretary, and the estate of Mark Perri, our former Chairman of the Board. In the fiscal quarters ended January 31, 2006 and 2005, we paid the management company approximately $11,000 and $8,600, respectively, in management fees.

New Accounting Pronouncements

In December 2004, the FASB issued Statement of Financial Accounting Standards No. 123(R), "Share-Based Payment" ("SFAS 123(R)"), which requires all companies to measure compensation cost for all share-based payments (including employee stock options) at fair value and to recognize cost over the vesting period. In March 2005, the SEC released SEC Staff Accounting Bulletin No. 107, "Share-Based Payment" ("SAB 107"). SAB 107 provides the SEC staff position regarding the application of SFAS 123(R), including interpretive guidance related to the interaction between SFAS 123(R) and certain SEC rules and regulations, and provides the staff's views regarding the valuation of share-based payment arrangements for public companies. SAB 107 highlights the importance of disclosures made related to the accounting for share-based payment transactions. In April 2005, the SEC announced that companies may implement SFAS 123(R) at the beginning of their next fiscal year beginning after June 15, 2005, or December 15, 2005 for small business issuers. The Company implemented the provisions of SFAS 123(R) and SAB 107 in the first quarter of fiscal 2006 using the modified-prospective method, and it did not have a material impact on our financial position or cash flows. See Note 3 - "Stock Based Compensation" for further information and the required disclosures under SFAS 123(R) and SAB 107, including the impact of the implementation on our results of operations.

In December 2004, the FASB issued SFAS No. 153, "Exchanges of Nonmonetary Assets - an amendment of APB Opinion No. 29." The statement addresses the measurement of exchanges of nonmonetary assets and eliminates the exception from fair value measurement for nonmonetary exchanges of similar productive assets and replaces it with an exception for exchanges that do not have commercial substance. SFAS No. 153 is effective for nonmonetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. This adoption of this statement did not have a significant impact on our consolidated results of operations or our financial position.
 
 
45


 
In May 2005, the FASB issued SFAS No. 154, “Accounting Changes and Error Corrections.” This statement replaces APB No. 20 and SFAS No. 3 and changes the requirements for the accounting for and reporting of a change in accounting principle. APB No. 20 previously required that most voluntary changes in accounting principle be recognized by including in net income of the period of the change the cumulative effect of changing to the accounting principle. SFAS No. 154 requires retrospective application to prior periods’ financial statements of voluntary changes in accounting principle. SFAS No. 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005. We are currently evaluating the impact of adopting this statement.

In February 2006, the FASB issued SFAS No. 155,”Accounting for Certain Hybrid Financial Instruments - an amendment of FASB Statements No. 133 and 140,” to simplify and make more consistent the accounting for certain financial instruments. Specifically, SFAS No. 155 amends SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, to permit fair value remeasurement for any hybrid financial instrument with an embedded derivative that otherwise would require bifurcation, provided that the whole instrument is accounted for on a fair value basis. SFAS No. 155 amends SFAS No. 140, Accounting for the Impairment or Disposal of Long-Lived Assets, to allow a qualifying special-purpose entity (SPE) to hold a derivative financial instrument that pertains to a beneficial interest other than another derivative financial instrument. SFAS No. 155 applies to all financial instruments acquired or issued after the beginning of an entity’s first fiscal year that begins after September 15, 2006, with earlier application allowed. The Company does not expect that the adoption of SFAS No. 155 will have a significant impact on the consolidated results of operations or financial position of the Company.


Risk Factors

In addition to historical facts or statements of current condition, this Quarterly Report on Form 10-Q contains forward-looking statements. Forward-looking statements provide our current expectations or forecasts of future events.

The following discussion outlines certain factors that we think could cause our actual outcomes and results to differ materially from our forward-looking statements. These factors are in addition to those set forth elsewhere in this Quarterly Report on Form 10-Q.

Risks Related to Our Financial Condition

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 expect to receive some revenue from the sale of our oral insulin product in Ecuador in fiscal 2006. To date, we have not been profitable and our accumulated net loss was $143,931,923 at January 31, 2006. 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 our oral insulin formulation which was approved for commercial sale in Ecuador in early May 2005, 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 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.
 
 
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We need additional capital.

To progress in product development, production, marketing, and distribution we will need additional capital which may not be available to us. This may delay our progress in product development or market.

We will require funds in excess of our existing cash resources:

 
Ÿ
to proceed with the development of our buccal insulin product;

 
Ÿ
to develop other buccal and immunomedicine products;

 
Ÿ
to develop new products based on our buccal delivery and immunomedicine technologies, including clinical testing relating to new products;

 
Ÿ
to develop or acquire other technologies or other lines of business;

 
Ÿ
to establish and expand our manufacturing capabilities;

 
Ÿ
to finance general and administrative and research activities that are not related to specific products under development;

 
Ÿ
to finance the research and development activities of our subsidiary Antigen; and

 
Ÿ
to otherwise carry on business.

In the past, we have funded most of our development and other costs through equity financing. We anticipate that our existing capital resources will enable us to maintain currently planned operations through the next 12 months. However, this expectation is based on our current operating plan, which could change as a result of many factors, and we may need additional funding sooner than anticipated. Because our operating and capital resources are insufficient to meet future requirements, we will have to raise additional funds in the near future to continue the development and commercialization of our products. Unforeseen problems, including materially negative developments in our clinical trials or in general economic conditions, could interfere with our ability to raise additional equity capital or materially adversely affect the terms upon which such funding is available. Recent changes in the application of the rules of The Nasdaq Stock Market may also make it more difficult for us to raise private equity capital.

It is possible that we will be unable to obtain additional funding as and when we need it. If we were unable to obtain additional funding as and when needed, we could be forced to delay the progress of certain development efforts. Such a scenario poses risks. For example, our ability to bring a product to market and obtain revenues could be delayed, our competitors could develop products ahead of us, and/or we could be forced to relinquish rights to technologies, products or potential products.

Our independent auditors have expressed substantial doubt about our ability to continue as a going concern.

In their audit opinion issued in connection with our consolidated balance sheet as of July 31, 2005 and our consolidated statements of operations, stockholders’ equity and cash flows for the year then ended and for the period from November 2, 1995 (date of inception) to July 31, 2005, our auditors have expressed a substantial doubt about our ability to continue as a going concern given our recurring net losses, negative cash flows from operations and working capital deficiency.

The accompanying financial 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 financial 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 we be unable to continue in existence.
 
 
47


 
New equity financing could dilute current stockholders.

If we raise funds through equity financing to meet the needs discussed above, it will have a 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 need 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.

Our research and development and marketing efforts may be highly dependent on corporate collaborators and other third parties who may not devote sufficient time, resources and attention to our programs, which may limit our efforts to successfully develop and market potential products.

Because we have limited resources, we have sought to enter into collaboration agreements with other pharmaceutical companies that will assist us in developing, testing, obtaining governmental approval for and commercializing products using our buccal delivery and immunomedicine technologies. Any collaborator with whom we may enter into such collaboration agreements may not support fully our research and commercial interests since our program may compete for time, attention and resources with such collaborator's internal programs. Therefore, these collaborators may not commit sufficient resources to our program to move it forward effectively, or that the program will advance as rapidly as it might if we had retained complete control of all research, development, regulatory and commercialization decisions.

Risks Related to Our Technologies

With the exceptions of Generex Oral-lyn™ and Glucose RapidSpray™, our technologies and products are at an early stage of development and we cannot expect revenues in respect thereof in the foreseeable future.

With the exception of Generex Oral-lyn™, our proprietary oral insulin spray formulation which has been approved for commercial marketing and sale in Ecuador for the treatment of Type-1 and Type-2 diabetes, and Glucose RapidSpray™, an over-the-counter confectionary, we have no products approved for commercial sale at the present time. To be profitable, we must not only successfully research, develop and obtain regulatory approval for our products under development, but also manufacture, introduce, market and distribute them once development is completed. We may not be successful in one or more of these stages of the development or commercialization of our products, and/or any of the products we develop may not be commercially viable.

While over 1,100 patients with diabetes have been dosed with our oral insulin formulation at approved facilities in seven countries, our insulin product has only recently been approved for marketing in Ecuador. Until we can manufacture, market and distribute our oral insulin product in Ecuador and can establish that it is a commercially viable product, we will not receive revenues from ongoing operations.

Until we receive regulatory approval to sell our products in one or more countries other than Ecuador, our ability to generate revenues from operations may be limited and those revenues may be insufficient to sustain operations. Many factors impact our ability to obtain approvals for commercially viable products.

Only one of our products has been approved for commercial sale by drug regulatory authorities, and that approval was obtained in Ecuador. We have begun the regulatory approval process for our oral insulin formulation, buccal morphine product in other countries. Our immunomedicine products are in the pre-clinical stage of development, with the exception of our Phase 1 trial in human patients with stage II HER-2/neu positive breast cancer.
 
 
48


 
Pre-clinical and clinical trials of our products, and the manufacturing and marketing of our technologies, are subject to extensive, costly and rigorous regulation by governmental authorities in the United States, Canada and other countries. The process of obtaining required regulatory approvals from the FDA and other regulatory authorities often takes many years, is expensive and can vary significantly based on the type, complexity and novelty of the product candidates. For these reasons, it is possible we will never receive approval for one or more product candidates in any country other than Ecuador.

In addition, we cannot be sure when or if we will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements in this Quarterly Report on Form 10-Q regarding the expected timing of clinical trials cannot be regarded as actual predictions of when we will obtain regulatory approval for any "phase" of clinical trials.

Delays in obtaining United States or other foreign approvals for our products could result in substantial additional costs to us, and, therefore, could adversely affect our ability to compete with other companies. If regulatory approval is ultimately granted in any country other than Ecuador, the approval may place limitations on the intended use of the product we wish to commercialize, and may restrict the way in which we are permitted to market the product.

Due to legal and factual uncertainties regarding the scope and protection afforded by patents and other proprietary rights, we may not have meaningful protection from competition.

Our long-term success will substantially depend upon our ability to protect our proprietary technologies from infringement, misappropriation, discovery and duplication and avoid infringing the proprietary rights of others. Our patent rights, and the patent rights of biotechnology and pharmaceutical companies in general, are highly uncertain and include complex legal and factual issues. Because of this, our pending patent applications may not be granted. These uncertainties also mean that any patents that we own or will obtain in the future could be subject to challenge, and even if not challenged, may not provide us with meaningful protection from competition. Due to our financial uncertainties, we may not possess the financial resources necessary to enforce our patents. Patents already issued to us or our pending applications may become subject to dispute, and any dispute could be resolved against us.

Because a substantial number of patents have been issued in the field of alternative drug delivery and because patent positions can be highly uncertain and frequently involve complex legal and factual questions, the breadth of claims obtained in any application or the enforceability of our patents cannot be predicted. Consequently, we do not know whether any of our pending or future patent applications will result in the issuance of patents or, to the extent patents have been issued or will be issued, whether these patents will be subject to further proceedings limiting their scope, will provide significant proprietary protection or competitive advantage, or will be circumvented or invalidated.

Also because of these legal and factual uncertainties, and because pending patent applications are held in secrecy for varying periods in the United States and other countries, even after reasonable investigation we may not know with certainty whether any products that we (or a licensee) may develop will infringe upon any patent or other intellectual property right of a third party. For example, we are aware of certain patents owned by third parties that such parties could attempt to use in the future in efforts to affect our freedom to practice some of the patents that we own or have applied for. Based upon the science and scope of these third-party patents, we believe that the patents that we own or have applied for do not infringe any such third-party patents; however, we cannot know for certain whether we could successfully defend our position, if challenged. We may incur substantial costs if we are required to defend the Company in patent suits brought by third parties. These legal actions could seek damages and seek to enjoin testing, manufacturing and marketing of the accused product or process. In addition to potential liability for significant damages, we could be required to obtain a license to continue to manufacture or market the accused product or process.

Risks Related to Marketing of Our Potential Products

We may not become, or stay, profitable even if our products are approved for sale.
 
 
49


 
Even if we obtain regulatory approval to market our oral insulin product or any other product candidate in another country other than Ecuador, many factors may prevent the product from ever being sold in commercial quantities. Some of these factors are beyond our control, such as:

 
Ÿ
acceptance of the formulation or treatment by health care professionals and diabetic patients;

 
Ÿ
the availability, effectiveness and relative cost of alternative diabetes or immunomedicine treatments that may be developed by competitors; and

 
Ÿ
the availability of third-party (i.e., insurer and governmental agency) reimbursements.

We will not receive revenues from our oral insulin formulation in Ecuador or any of our other products that may receive regulatory approval until we can successfully manufacture, market and distribute them in the relevant market.

We will have to depend upon others for marketing and distribution of our products, including Generex Oral-lyn™ in Ecuador, and we may be forced to enter into contracts limiting the benefits we may receive and the control we have over our products. We intend to rely on collaborative arrangements with one or more other companies that possess strong marketing and distribution resources to perform these functions for us. We may not be able to enter into beneficial contracts, and we may be forced to enter into contracts for the marketing and distribution of our products that substantially limit the potential benefits to us from commercializing these products. In addition, we will not have the same control over marketing and distribution that we would have if we conducted these functions ourselves.

We may not be able to compete with treatments now being marketed and developed, or which may be developed and marketed in the future by other companies.

Our products will compete with existing and new therapies and treatments. We are aware of a number of companies currently seeking to develop alternative means of delivering insulin, as well as new drugs intended to replace insulin therapy at least in part. We are also aware of a number of companies currently seeking to develop alternative means of enhancing and suppressing peptides. In the longer term, we also face competition from companies that seek to develop cures for diabetes and other malignant, infectious, autoimmune and allergic diseases through techniques for correcting the genetic deficiencies that underlie such diseases.

Numerous pharmaceutical, biotechnology and drug delivery companies, hospitals, research organizations, individual scientists and nonprofit organizations are engaged in the development of alternatives to our technologies. Some of these companies have greater research and development capabilities, experience, manufacturing, marketing, financial and managerial resources than we do. Accordingly, our competitors may succeed in developing competing technologies, obtaining FDA approval for products or gaining market acceptance more rapidly than we can.

In January, 2006, the FDA approved Pfizer, Inc.’s inhalable form of insulin, the first non-injected insulin to be approved by the FDA. Pfizer’s product in inhaled through the mouth and absorbed in the lungs. While we believe that absorption though the buccal cavity offers several advantages over absorption through the lungs, Pfizer’s early approval could allow it to capture a large portion of the market.

If government programs and insurance companies do not agree to pay for or reimburse patients for our products, our success will be impacted.

Sales of our oral insulin formulation in Ecuador and our potential products in other markets depend in part on the availability of reimbursement by third-party payers such as government health administration authorities, private health insurers and other organizations. Third-party payers often challenge the price and cost-effectiveness of medical products and services. Governmental approval of health care products does not guarantee that these third-party payers will pay for the products. Even if third-party payers do accept our product, the amounts they pay may not be adequate to enable us to realize a profit. Legislation and regulations affecting the pricing of pharmaceuticals may change before our products are approved for marketing and any such changes could further limit reimbursement.
 
 
50


 
Risks Related to Potential Liabilities

We face significant product liability risks, which may have a negative effect on our financial condition.

The administration of drugs or treatments to humans, whether in clinical trials or commercially, can result in product liability claims whether or not the drugs or treatments are actually at fault for causing an injury. Furthermore, our products may cause, or may appear to have caused, serious adverse side effects (including death) or potentially dangerous drug interactions that we may not learn about or understand fully until the drug or treatment has been administered to patients for some time. Product liability claims can be expensive to defend and may result in large judgments or settlements against us, which could have a severe negative effect on our financial condition. We maintain product liability insurance in amounts we believe to be commercially reasonable for our current level of activity and exposure, but claims could exceed our coverage limits. Furthermore, due to factors in the insurance market generally and our own experience, we may not always be able to purchase sufficient insurance at an affordable price. Even if a product liability claim is not successful, the adverse publicity and time and expense of defending such a claim may interfere with our business.


Risks Related to the Market for Our Common Stock

Our common stock could be delisted from The Nasdaq Capital Market.

On June 5, 2003, our common stock was delisted from The Nasdaq National Market because of our failure to maintain a minimum of $10,000,000 in stockholders' equity. On June 5, 2003, our stock began trading on The Nasdaq Capital Market. The Nasdaq Capital Market has its own standards for continued listing, including a minimum of $2.5 million stockholders' equity. As of July 31, 2004, our stockholders' equity was $529,751. As a result, on November 19, 2004, we received notice from The Nasdaq Stock Market informing us that we do not comply with Marketplace Rule 4310(c)(2)(B), which requires us to have a minimum of $2,500,000 in stockholders' equity or $35,000,000 market value of listed securities or $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recently completed fiscal years. On December 22, 2004, all outstanding shares of our Series A Convertible Preferred Stock were converted to common stock, resulting in the elimination of approximately $14,300,000 of mezzanine equity and an equal amount was added to additional paid-in capital attributable to the common stock, increasing stockholders' equity by that amount. Based on this, the delisting proceeding relating to failure to meet stockholders’ equity standards was terminated. Because we are still in the development stage, there is no guarantee that we will sustain compliance with this standard. In the event we cannot sustain compliance, our shares of common stock may be delisted from The Nasdaq Capital Market and begin trading on the over-the-counter bulletin board.

In addition, for continued listing on both The Nasdaq National Market and Capital Market, our stock price must be at least $1.00. From October of 2004 until October 2005, our stock price traded below this minimum per share requirement for thirty (30) or more consecutive business days. As a result, on November 24, 2004, we received notice from The Nasdaq Stock Market informing us that we did not comply with Market Rule 4310(c)(4), which requires us to have a minimum bid price per share of at least $1.00 for thirty (30) consecutive business days. We had 180 calendar days, or until May 23, 2005, subject to extension by The Nasdaq Stock Market under certain circumstances, to regain compliance with the Rule.

On May 25, 2005, we received notice from the Staff of The Nasdaq Stock Market informing us that, during the 180 calendar day period ending May 23, 2005, we had not regained compliance with Marketplace Rule 4310(c)(4); however, the Staff noted that on May 23, 2005, we met all initial inclusion criteria for the Capital Market set forth in Marketplace Rule 4310(c), except for bid price. Therefore, in accordance with Marketplace Rule 4310(c)(8)(D), we had an additional 180 calendar days to regain compliance with Rule 4310(c)(4).
 
 
51


 
On November 14, 2005, we received written confirmation from The Nasdaq Stock Market that we achieved compliance with the continued listing requirements in accordance with the minimum bid price requirement under Nasdaq Marketplace Rule 4310(c)(4).

Although we have regained compliance with the minimum bid price requirement, there is no guarantee that the bid price of our common stock will remain at or above $1.00 per share. In the event that the price of our common stock falls below $1.00 per share for thirty (30) consecutive business days, we would likely receive a notice from The Nasdaq Stock Market informing us of our noncompliance with Market Rule 4310(c)(4) and giving us 180 calendar days, subject to extension, to regain compliance with the Rule. In the event that we could not demonstrate compliance with Marketplace Rule 4310(c)(4) by the specified deadline and were not eligible for an additional compliance period, the Staff would notify us that our stock would be delisted, at which time we could appeal the Staff’s determination to a Listing Qualifications Panel. Pending the decision of the Listing Qualification Panel, our common stock would continue to trade on the Capital Market. If we were not successful in such an appeal, our stock would likely trade on NASDAQ’s over-the-counter bulletin board, assuming we meet the requisite criteria.

If we fail to maintain compliance with applicable Nasdaq Marketplace Rules and our stock is delisted from the NASDAQ Capital Market, it may become subject to Penny Stock Regulations and there will be less interest for our stock in the market. This may result in lower prices for our stock and make it more difficult for us to obtain financing.

If our stock is not listed on NASDAQ and fails to maintain a price of $5.00 or more per share, our stock would become subject to the Securities and Exchange Commission's "Penny Stock" rules. These rules require a broker to deliver, prior to any transaction involving a Penny Stock, a disclosure schedule explaining the Penny Stock Market and its risks. Additionally, broker/dealers who recommend Penny Stocks to persons other than established customers and accredited investors must make a special written suitability determination and receive the purchaser's written agreement to a transaction prior to the sale. In the event our stock becomes subject to these rules, it will become more difficult for broker/dealers to sell our common stock. Therefore, it may be more difficult for us to obtain financing.

The price of our common stock may be volatile.

There may be wide fluctuations in the price of our common stock. These fluctuations may be caused by several factors including:

 
Ÿ
announcements of research activities and technology innovations or new products by us or our competitors;

 
Ÿ
changes in market valuation of companies in our industry generally;

 
Ÿ
variations in operating results;

 
Ÿ
changes in governmental regulations;

 
Ÿ
developments in patent and other proprietary rights;

 
Ÿ
public concern as to the safety of drugs or treatments developed by us or others;

 
Ÿ
results of clinical trials of our products or our competitors' products; and

 
Ÿ
regulatory action or inaction on our products or our competitors' products.

From time to time, we may hire companies to assist us in pursuing investor relations strategies to generate increased volumes of investment in our common stock. Such activities may result, among other things, in causing the price of our common stock to increase on a short-term basis.
 
 
52


 
Furthermore, the stock market generally and the market for stocks of companies with lower market capitalizations and small biopharmaceutical companies, like us, have from time to time experienced, and likely will again experience significant price and volume fluctuations that are unrelated to the operating performance of a particular company.

Our outstanding Special Voting Rights Preferred Stock and provisions of our Restated Certificate of Incorporation could delay or prevent the acquisition or sale of our business.

Holders of our Special Voting Rights Preferred Stock have the ability to prevent any change of control in us. Dr. Pankaj Modi, a former officer and director of Generex, owns all of our Special Voting Rights Preferred Stock. In addition, our Restated Certificate of Incorporation permits our Board of Directors to designate new series of preferred stock and issue those shares without any vote or action by our stockholders. Such newly authorized and issued shares of preferred stock could contain terms that grant special voting rights to the holders of such shares that make it more difficult to obtain stockholder approval for an acquisition of our business or increase the cost of any such acquisition.

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, 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. At the present time, with the exception of professional fees and costs associated with the conduct of clinical trials in the United States and Europe, substantially all of our operating expense obligations are denominated in Canadian dollars. 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, 2005, we have fixed rate debt totaling $3,415,426. This amount consists of the following:


 
Loan Amount
Interest Rate per Annum
 
 
$807,393
5.8%
 
 
$428,021
4.913%
 
 
$265,379
4.924%
 
 
$644,779
6.85%
 
 
$348,520
8.5%
 
 
$206,868
10%
 
 
$435,650
11.5%
 
 
$278,816
16.5%
 
 
$3,415,426
Total
 

These debt instruments mature from February 2006 through November 2008 As our fixed rate debt instruments mature, we will likely refinance such debt at the existing market interest rates which may be more or less than interest rates on the maturing debt. Since this debt is fixed rate debt, if interest rates were to increase 100 basis points prior to maturity, there would be no impact on earnings or cash flows.

We have neither issued nor own any long-term debt instruments, or any other financial instruments, for trading purposes and as to which we would be subject to material market risks.

Item 4. Controls and Procedures.
 
 
53


 
Evaluation of disclosure controls and procedures

Based on our management's evaluation (with the participation of our principal executive officer and principal financial officer), as of the end of the period covered by this Quarterly Report on Form 10-Q, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the "Exchange Act")) are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Changes in internal control over financial reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act) during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
 
 
54


 
PART II - OTHER INFORMATION

Item 1. Legal Proceedings.

None.

Item 1A. Risk Factors


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

Unregistered Sales of Equity Securities

In the fiscal quarter ended January 31, 2006, we sold common stock, warrants, convertible debentures and additional investment rights in the amounts and to the purchasers described above in this Quarterly Report under Part I - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations- Financial Condition, Liquidity and Resources. We undertook the offer and sale of these securities in reliance upon Rule 506 of Regulation D and Section 18(b)(4)(D) of the Securities Act of 1933, as amended.

Issuer Purchases of Equity Securities

Neither we nor any affiliated purchaser (as defined in Section 240.10 b-18(a)(3) of the Exchange Act) purchased any of our equity securities during the fiscal quarter ended October 31, 2005.

Item 3. Defaults Upon Senior Securities.

On September 20, 2005, we did not pay the outstanding principal balances under the $500,000 convertible promissory note entered into with Cranshire on March 28, 2005 and the $100,000 convertible promissory note entered into with Omicron on April 6, 2005. On October 19, 2005 Cranshire converted outstanding principal and accrued interest on its note ($528,082 in total) into 644,003 shares of our common stock. On October 27, 2005 Omicron converted outstanding principal and accrued interest on its note ($105,644 in total) into 128,834 shares of common stock. Terms and conditions of the notes are described in this Quarterly Report on Form 10-Q above under the caption Financial Condition, Liquidity and Resources of Part I - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Under the terms of an Assistance Agreement with Eckert Seamans Cherin & Mellott, LLC, , we agreed to repay an advance of $325,179 without interest in three equal installments due on October 1, 2005, November 1, 2005 and December 1, 2005. We have not paid any of the installments due under the Assistance Agreement. Because we did not make the first installment payment on October 1, 2005 as of that date, all amounts owed to Eckert Seamans became payable on demand, and interest on such unpaid amounts began accruing at the rate of 8% per annum. The attached financial statements reflect interest accrual on this advance as of January 31, 2006. We are currently in negotiations with Eckert Seamans and are seeking to extend the payment dates or to pay the outstanding balance with shares of our common stock. The total interest arrearage to date under the Assistance Agreement is approximately $22,190.The terms and conditions of the Assistance Agreement with Eckert Seamans, are described in this Quarterly Report on Form 10-Q above under the caption Financial Condition, Liquidity and Resources of Part I - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Item 4. Submission of Matters to a Vote of Security Holders.

None.

Item 5. Other Information.
 
 
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The disclosures set forth under Part II - Item 2. Unregistered Sales of Equity Securities and Use of Proceeds and Part II - Item 3. Defaults Upon Senior Securities are incorporated herein by reference.

Item 6. Exhibits.
 
Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
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)
 
Restated Certificate of Incorporation of Generex Biotechnology Corporation, as amended (incorporated by reference to Exhibit 3.1 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on March 15, 2004)
     
3(II)
 
Bylaws of Generex Biotechnology Corporation (incorporated by reference to Exhibit 3.2 to Generex Biotechnology Corporation’s Registration Statement on Form S-1 (File No. 333-82667) filed on July 12, 1999)
     
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
 
Certificate of Designations, Preferences and Rights of Series A Preferred Stock (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 23, 2001)
     
4.3
 
Form of Warrant issued to Ladenburg Thalmann & Co., Inc. dated July 6, 2001 (incorporated by reference to Exhibit 4.15 to Generex Biotechnology Corporation’s Registration Statement on Form S-3 (File No. 333-67118) filed on August 8, 2001)
     
4.4
 
Form of Warrant granted to Cranshire Capital, L.P.; RAM Trading Ltd.; Gryphon Master Fund; Kodiak Opportunity, L.P.; Kodiak Opportunity 3C7, L.P.; Kodiak Opportunity Offshore, Ltd.; Novelly Exempt Trust; Langley Partners, L.P.; Montrose Investments, Ltd.; WEC Asset Management, LLC; ZLP Master Technology Fund, Ltd.; Alpha Capital Aktiengesellschaft; and The dotCOM Fund, LLC, dated July 6, 2001 (incorporated by reference to Exhibit 3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 17, 2001)
     
4.5
 
Warrant granted to Capital Ventures International, dated July 3, 2001 (incorporated by reference to Exhibit 6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 17, 2001)
     
4.6
 
Warrant issued to Elliott International, L.P. and Elliott Associates, L.P., dated July 5, 2001 (incorporated by reference to Exhibit 9 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 17, 2001)
     
4.7
 
Form of Warrant issued to certain parties to October 2000 Private Placement (incorporated by reference to Exhibit 4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 16, 2000)
     
4.8
 
Form of Warrant (GCR Series) held by Robert P. Carter, Harvey Kaye, Fittube, Inc., Edward Maskaly and Gulfstream Capital Group, L.C. (incorporated by reference to Exhibit 4.4.2 to Generex Biotechnology Corporation’s Registration Statement on Form 10 filed on December 14, 1998, as amended February 24, 1999)
     
4.9
 
Letter Agreement and Warrant with M. H. Meyerson & Co., Inc. dated November 17, 1998 (incorporated by reference to Exhibit 4.4.4 to Generex Biotechnology Corporation’s Registration Statement on Form 10 filed on December 14, 1998, as amended February 24, 1999)
 
 
56


 
Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.10.1
 
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 April 30, 2003 filed on August 13, 2003)
     
4.10.2
 
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 April 30, 2003 filed on August 13, 2003)
     
4.10.3
 
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 April 30, 2003 filed on August 13, 2003)
     
4.10.4
 
Form of Securities Purchase Agreement entered into with Cranshire Capital, L.P. dated June 6, 2003 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003 filed on August 13, 2003)
     
4.10.5
 
Form of Registration Rights Agreement entered into with Cranshire Capital, L.P. dated June 6, 2003 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003 filed on August 13, 2003)
     
4.10.6
 
Form of Warrant granted to Cranshire Capital, L.P. dated June 6, 2003 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003 filed on August 13, 2003)
     
4.10.7
 
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)
     
4.11.1
 
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)
     
4.11.2
 
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)
     
4.11.3
 
Form of Warrant issued in connection with Exhibit 4.11.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.11.4
 
Form of Additional Investment Right issued in connection with Exhibit 4.11.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
 
 
57


 
Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.12.1
 
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)
     
4.12.2
 
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)
     
4.12.3
 
Warrant issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.12.4
 
Additional Investment Right issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.13.1
 
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)
     
4.13.2
 
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)
     
4.13.3
 
Warrant issued in connection with Exhibit 4.13.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.13.4
 
Additional Investment Right issued in connection with Exhibit 4.13.1 (incorporated by reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.14.1
 
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)
     
4.14.2
 
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)
     
4.14.3
 
Warrant issued in connection with Exhibit 4.14.1 (incorporated by reference to Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.14.4
 
Additional Investment Right issued in connection with Exhibit 4.14.1 (incorporated by reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.14.5
 
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)
     
4.15.1
 
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)
     
4.15.2
 
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)
 
 
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Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.15.3
 
Warrant issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.16 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.15.4
 
Additional Investment Right issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.16.1
 
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)
     
4.16.2
 
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)
     
4.16.3
 
Warrant issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.16.4
 
Additional Investment Right issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.17.1
 
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)
     
4.17.2
 
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)
     
4.17.3
 
Form of Warrant issued in connection with Exhibit 4.17.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.17.4
 
Form of Additional Investment Right issued in connection Exhibit 4.17.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.18.1
 
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)
     
4.18.2
 
Form of 6% Secured Convertible Debenture issued in connection with Exhibit 4.21.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.18.3
 
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)
     
4.18.4
 
Form of Warrant issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
59

 

Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.18.5
 
Form of Additional Investment Right issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.18.6
 
Custodial and Security Agreement, dated November 10, 2004, by and among Generex Biotechnology Corporation, Feldman Weinstein LLP, as custodian, and the investors named therein (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.18.7
 
Form of Voting Agreement entered into in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.19
 
Termination Agreement, dated December 17, 2004, by and among Generex Biotechnology Corporation and Elan Corporation plc and Elan International Services, Ltd. (incorporated by reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.20
 
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)
     
4.21.1
 
Promissory Note and Agreement, dated March 28, 2005 by and between Generex Biotechnology Corporation and Cranshire Capital, L.P. (incorporated by reference to Exhibit 4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on April 1, 2005)
     
4.21.2
 
Warrant issued to Cranshire Capital, L.P. entered into in connection with Exhibit 4.21.1 (incorporated by reference to Exhibit 4.21.2 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.22.1
 
Promissory Note and Agreement, entered into April 6, 2005 by and between Generex Biotechnology Corporation and Omicron Master Trust (incorporated by reference to Exhibit 4.22.1 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.22.2
 
Warrant issued to Omicron Master Trust entered into in connection with Exhibit 4.22.1 (incorporated by reference to Exhibit 4.22.2 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.23.1
 
June 7, 2005 Amendment to Promissory Note and Agreement, dated March 28, 2005 by and between Generex Biotechnology Corporation and Cranshire Capital, L.P. (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 10, 2005)
     
4.23.2
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on June 7, 2005 in connection with Exhibit 4.23.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 10, 2005)
     
4.24.1
 
June 7, 2005 Amendment to Promissory Note and Agreement, entered into April 6, 2005 by and between Generex Biotechnology Corporation and Omicron Master Trust (incorporated by reference to Exhibit 4.24.1 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.24.2
 
Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on June 7, 2005 in connection with Exhibit 4.24.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 10, 2005)
 
 
60



Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.25.1
 
Amendment No. 1 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 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 17, 2005)
     
4.25.2
 
Form of AIR Debenture issued in connection with Exhibit 4.25.1 (incorporated by reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.25.3
 
Form of AIR Warrant issued in connection with Exhibit 4.25.1(incorporated by reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.25.4
 
Form of Additional AIR issued in connection with Exhibit 4.25.1 (incorporated by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.26.1
 
Amendment No. 2 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 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
     
4.26.2
 
Form of Air Debenture issued 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 9, 2005)
     
4.26.3
 
Form of AIR Warrant issued in connection with Exhibit 4.26.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
     
4.26.4
 
Form of Additional AIR issued in connection with Exhibit 4.26.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
     
4.27.1
 
July 22, 2005 Amendment to Promissory Note and Agreement, entered into March 28, 2005 by and between Generex Biotechnology Corporation and Cranshire Capital, L.P. (incorporated by reference to Exhibit 4.27.1 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.27.2
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on July 22, 2005 in connection with Exhibit 4.27.1 (incorporated by reference to Exhibit 4.27.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.28.1
 
June 22, 2005 Amendment to Promissory Note and Agreement, entered into April 6, 2005 by and between Generex Biotechnology Corporation and Omicron Master Trust (incorporated by reference to Exhibit 4.28.1 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.28.2
 
Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on July 22, 2005 in connection with Exhibit 4.28.1 (incorporated by reference to Exhibit 4.28.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.29
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on October 20, 2005 (incorporated by reference to Exhibit 4.29 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
 
61

 

Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.30
 
Warrant issued by Generex Biotechnology Corporation to Iroquois Capital, L.P. on October 20, 2005 (incorporated by reference to Exhibit 4.30 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.31
 
Form of Warrant issued by Generex Biotechnology Corporation on October 27, 2005 (incorporated by reference to Exhibit 4.31 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.32
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on June 17, 2005 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.33
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology Corporation to Smithfield Fiduciary LLC on June 17, 2005 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.34
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on June 17, 2005 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.35
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology to Iroquois Capital LP on June 17, 2005 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.36
 
Amendment to the Additional Investment Right issued by Generex Biotechnology Corporation to Omicron Master Trust on June 17, 2005 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.37
 
Additional AIR Debenture issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.36
     
4.38
 
Additional AIR Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.36
     
4.39
 
Amendment No. 3 to Securities Purchase Agreement and Registration Rights Agreement entered into by and among Generex Biotechnology Corporation and the Purchasers listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.40
 
Form of AIR Debentures issued 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 December 5, 2005)
     
4.41
 
Form of AIR Warrants issued in connection with Exhibit 4.39 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.42
 
Form of Additional AIRs issued in connection with Exhibit 4.39 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
62

 

Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.43
 
Form of Amendment to the Additional Investment Right issued by Generex Biotechnology Corporation on June 17, 2005 in connection with the First AIR Exercise (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.44
 
Form of Amendment to the Additional Investment Right issued by Generex Biotechnology Corporation on September 8, 2005 in connection with the Second AIR Exercise (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.45
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on December 9, 2005
     
4.46
 
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)
     
4.47
 
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)
     
9
 
Form of Voting Agreement entered into in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
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
 
(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.

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 15, 2006
By:   /s/ Anna E. Gluskin
 
 
Anna E. Gluskin
Chairman, President and Chief Executive Officer
     
   
 
 
 
 
 
 
Date: March 15, 2006
By:   /s/ Rose C. Perri
 
 
Rose C. Perri
Chief Operating Officer, Chief Financial Officer, Treasurer and Secretary

63

 
Generex Biotechnology Corporation
Form 10-Q
January 31, 2006
Exhibit Index



Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
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)
 
Restated Certificate of Incorporation of Generex Biotechnology Corporation, as amended (incorporated by reference to Exhibit 3.1 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on March 15, 2004)
     
3(II)
 
Bylaws of Generex Biotechnology Corporation (incorporated by reference to Exhibit 3.2 to Generex Biotechnology Corporation’s Registration Statement on Form S-1 (File No. 333-82667) filed on July 12, 1999)
     
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
 
Certificate of Designations, Preferences and Rights of Series A Preferred Stock (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 23, 2001)
     
4.3
 
Form of Warrant issued to Ladenburg Thalmann & Co., Inc. dated July 6, 2001 (incorporated by reference to Exhibit 4.15 to Generex Biotechnology Corporation’s Registration Statement on Form S-3 (File No. 333-67118) filed on August 8, 2001)
     
4.4
 
Form of Warrant granted to Cranshire Capital, L.P.; RAM Trading Ltd.; Gryphon Master Fund; Kodiak Opportunity, L.P.; Kodiak Opportunity 3C7, L.P.; Kodiak Opportunity Offshore, Ltd.; Novelly Exempt Trust; Langley Partners, L.P.; Montrose Investments, Ltd.; WEC Asset Management, LLC; ZLP Master Technology Fund, Ltd.; Alpha Capital Aktiengesellschaft; and The dotCOM Fund, LLC, dated July 6, 2001 (incorporated by reference to Exhibit 3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 17, 2001)
     
4.5
 
Warrant granted to Capital Ventures International, dated July 3, 2001 (incorporated by reference to Exhibit 6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 17, 2001)
     
4.6
 
Warrant issued to Elliott International, L.P. and Elliott Associates, L.P., dated July 5, 2001 (incorporated by reference to Exhibit 9 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 17, 2001)
     
4.7
 
Form of Warrant issued to certain parties to October 2000 Private Placement (incorporated by reference to Exhibit 4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 16, 2000)
     
4.8
 
Form of Warrant (GCR Series) held by Robert P. Carter, Harvey Kaye, Fittube, Inc., Edward Maskaly and Gulfstream Capital Group, L.C. (incorporated by reference to Exhibit 4.4.2 to Generex Biotechnology Corporation’s Registration Statement on Form 10 filed on December 14, 1998, as amended February 24, 1999)
 
 
64

 

Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.9
 
Letter Agreement and Warrant with M. H. Meyerson & Co., Inc. dated November 17, 1998 (incorporated by reference to Exhibit 4.4.4 to Generex Biotechnology Corporation’s Registration Statement on Form 10 filed on December 14, 1998, as amended February 24, 1999)
     
4.10.1
 
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 April 30, 2003 filed on August 13, 2003)
     
4.10.2
 
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 April 30, 2003 filed on August 13, 2003)
     
4.10.3
 
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 April 30, 2003 filed on August 13, 2003)
     
4.10.4
 
Form of Securities Purchase Agreement entered into with Cranshire Capital, L.P. dated June 6, 2003 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003 filed on August 13, 2003)
     
4.10.5
 
Form of Registration Rights Agreement entered into with Cranshire Capital, L.P. dated June 6, 2003 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003 filed on August 13, 2003)
     
4.10.6
 
Form of Warrant granted to Cranshire Capital, L.P. dated June 6, 2003 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003 filed on August 13, 2003)
     
4.10.7
 
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)
     
4.11.1
 
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)
     
4.11.2
 
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)
     
4.11.3
 
Form of Warrant issued in connection with Exhibit 4.11.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.11.4
 
Form of Additional Investment Right issued in connection with Exhibit 4.11.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
 
 
65


 
Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.12.1
 
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)
     
4.12.2
 
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)
     
4.12.3
 
Warrant issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.12.4
 
Additional Investment Right issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.13.1
 
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)
     
4.13.2
 
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)
     
4.13.3
 
Warrant issued in connection with Exhibit 4.13.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.13.4
 
Additional Investment Right issued in connection with Exhibit 4.13.1 (incorporated by reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.14.1
 
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)
     
4.14.2
 
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)
     
4.14.3
 
Warrant issued in connection with Exhibit 4.14.1 (incorporated by reference to Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.14.4
 
Additional Investment Right issued in connection with Exhibit 4.14.1 (incorporated by reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.14.5
 
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)
     
4.15.1
 
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)
     
4.15.2
 
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)
 
 
66

 

Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.15.3
 
Warrant issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.16 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.15.4
 
Additional Investment Right issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.16.1
 
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)
     
4.16.2
 
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)
     
4.16.3
 
Warrant issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.16.4
 
Additional Investment Right issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.17.1
 
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)
     
4.17.2
 
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)
     
4.17.3
 
Form of Warrant issued in connection with Exhibit 4.17.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.17.4
 
Form of Additional Investment Right issued in connection Exhibit 4.17.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.18.1
 
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)
     
4.18.2
 
Form of 6% Secured Convertible Debenture issued in connection with Exhibit 4.21.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.18.3
 
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)
     
4.18.4
 
Form of Warrant issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
67


 
Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.18.5
 
Form of Additional Investment Right issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.18.6
 
Custodial and Security Agreement, dated November 10, 2004, by and among Generex Biotechnology Corporation, Feldman Weinstein LLP, as custodian, and the investors named therein (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.18.7
 
Form of Voting Agreement entered into in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.19
 
Termination Agreement, dated December 17, 2004, by and among Generex Biotechnology Corporation and Elan Corporation plc and Elan International Services, Ltd. (incorporated by reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.20
 
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)
     
4.21.1
 
Promissory Note and Agreement, dated March 28, 2005 by and between Generex Biotechnology Corporation and Cranshire Capital, L.P. (incorporated by reference to Exhibit 4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on April 1, 2005)
     
4.21.2
 
Warrant issued to Cranshire Capital, L.P. entered into in connection with Exhibit 4.21.1 (incorporated by reference to Exhibit 4.21.2 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.22.1
 
Promissory Note and Agreement, entered into April 6, 2005 by and between Generex Biotechnology Corporation and Omicron Master Trust (incorporated by reference to Exhibit 4.22.1 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.22.2
 
Warrant issued to Omicron Master Trust entered into in connection with Exhibit 4.22.1 (incorporated by reference to Exhibit 4.22.2 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.23.1
 
June 7, 2005 Amendment to Promissory Note and Agreement, dated March 28, 2005 by and between Generex Biotechnology Corporation and Cranshire Capital, L.P. (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 10, 2005)
     
4.23.2
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on June 7, 2005 in connection with Exhibit 4.23.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 10, 2005)
     
4.24.1
 
June 7, 2005 Amendment to Promissory Note and Agreement, entered into April 6, 2005 by and between Generex Biotechnology Corporation and Omicron Master Trust (incorporated by reference to Exhibit 4.24.1 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.24.2
 
Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on June 7, 2005 in connection with Exhibit 4.24.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 10, 2005)
 
 
68

 

Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.25.1
 
Amendment No. 1 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 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 17, 2005)
     
4.25.2
 
Form of AIR Debenture issued in connection with Exhibit 4.25.1 (incorporated by reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.25.3
 
Form of AIR Warrant issued in connection with Exhibit 4.25.1(incorporated by reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.25.4
 
Form of Additional AIR issued in connection with Exhibit 4.25.1 (incorporated by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.26.1
 
Amendment No. 2 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 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
     
4.26.2
 
Form of Air Debenture issued 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 9, 2005)
     
4.26.3
 
Form of AIR Warrant issued in connection with Exhibit 4.26.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
     
4.26.4
 
Form of Additional AIR issued in connection with Exhibit 4.26.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
     
4.27.1
 
July 22, 2005 Amendment to Promissory Note and Agreement, entered into March 28, 2005 by and between Generex Biotechnology Corporation and Cranshire Capital, L.P. (incorporated by reference to Exhibit 4.27.1 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.27.2
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on July 22, 2005 in connection with Exhibit 4.27.1 (incorporated by reference to Exhibit 4.27.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.28.1
 
June 22, 2005 Amendment to Promissory Note and Agreement, entered into April 6, 2005 by and between Generex Biotechnology Corporation and Omicron Master Trust (incorporated by reference to Exhibit 4.28.1 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.28.2
 
Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on July 22, 2005 in connection with Exhibit 4.28.1 (incorporated by reference to Exhibit 4.28.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
 
69

 

Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.29
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on October 20, 2005 (incorporated by reference to Exhibit 4.29 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.30
 
Warrant issued by Generex Biotechnology Corporation to Iroquois Capital, L.P. on October 20, 2005 (incorporated by reference to Exhibit 4.30 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.31
 
Form of Warrant issued by Generex Biotechnology Corporation on October 27, 2005 (incorporated by reference to Exhibit 4.31 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
     
4.32
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on June 17, 2005 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.33
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology Corporation to Smithfield Fiduciary LLC on June 17, 2005 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.34
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on June 17, 2005 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.35
 
Amendment to the Common Stock Purchase Warrant issued by Generex Biotechnology to Iroquois Capital LP on June 17, 2005 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.36
 
Amendment to the Additional Investment Right issued by Generex Biotechnology Corporation to Omicron Master Trust on June 17, 2005 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on October 31, 2005)
     
4.37
 
Additional AIR Debenture issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.36
     
4.38
 
Additional AIR Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.36
     
4.39
 
Amendment No. 3 to Securities Purchase Agreement and Registration Rights Agreement entered into by and among Generex Biotechnology Corporation and the Purchasers listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.40
 
Form of AIR Debentures issued 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 December 5, 2005)
     
4.41
 
Form of AIR Warrants issued in connection with Exhibit 4.39 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.42
 
Form of Additional AIRs issued in connection with Exhibit 4.39 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
70


 
Exhibit
   
Number
________
Description of Exhibit(1)
_____________________
4.43
 
Form of Amendment to the Additional Investment Right issued by Generex Biotechnology Corporation on June 17, 2005 in connection with the First AIR Exercise (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.44
 
Form of Amendment to the Additional Investment Right issued by Generex Biotechnology Corporation on September 8, 2005 in connection with the Second AIR Exercise (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
     
4.45
 
Warrant issued by Generex Biotechnology Corporation to Cranshire Capital, L.P. on December 9, 2005
     
4.46
 
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)
     
4.47
 
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)
     
9
 
Form of Voting Agreement entered into in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
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
 
(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.

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