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, 2007

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 a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer  o    Accelerated filer  x    Non-accelerated filer  o 

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

The number of outstanding shares of the registrant's common stock, par value $.001, was 108,274,731 as of March 7, 2007. 
 

 
GENEREX BIOTECHNOLOGY CORPORATION

INDEX

PART I. FINANCIAL INFORMATION
 
 
 
Item 1.     Financial Statements.
 
 
 
(Unaudited)
 
Consolidated Balance Sheets -
 
January 31, 2007 and July 31, 2006
1
 
 
Consolidated Statements of Operations for the three and six month
 
periods ended January 31, 2007 and 2006, and cumulative from
 
November 2, 1995 to January 31, 2007
2
 
 
Consolidated Statements of Cash Flows — For the six month
 
periods ended January 31, 2007 and 2006, and cumulative from
 
November 2, 1995 to January 31, 2007
3
 
 
Notes to Consolidated Financial Statements
5
 
 
Item 2.     Management's Discussion and Analysis of Financial Condition and Results of Operations
14
 
 
Item 3.     Quantitative and Qualitative Disclosures About Market Risk
24
 
 
Item 4.     Controls and Procedures
24
 
 
PART II: OTHER INFORMATION
 
 
 
Item 1.     Legal Proceedings
25
   
Item 1A. Risk Factors
25
   
Item 2.     Unregistered Sales of Equity Securities and Use of Proceeds
26
 
 
Item 3.     Defaults Upon Senior Securities
27
 
 
Item 4.     Submission of Matters to a Vote of Security Holders
27
 
 
Item 5.     Other Information
27
 
 
Item 6.     Exhibits
28
 
 
Signatures 
35
 


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements
 
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEETS
 
   
January 31,
 
July 31,
 
   
2007
 
2006
 
ASSETS
             
Current Assets:
             
Cash and cash equivalents
 
$
36,341,202
 
$
38,208,493
 
Short-term investments
   
8,296,981
   
14,372,653
 
Accounts receivable
   
115,230
   
 
Inventory
   
42,404
   
 
Other current assets
   
579,405
   
237,752
 
Total Current Assets
   
45,375,222
   
52,818,898
 
               
Property and Equipment, Net
   
2,281,369
   
2,585,744
 
Assets Held for Investment, Net
   
3,389,382
   
3,602,773
 
Patents, Net
   
4,986,607
   
5,097,827
 
               
TOTAL ASSETS
 
$
56,032,580
 
$
64,105,242
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
             
               
Current Liabilities:
             
Accounts payable and accrued expenses
 
$
5,079,766
 
$
5,444,790
 
Deferred revenue
   
15,475
   
 
Current maturities of long-term debt
   
73,639
   
428,059
 
Convertible Debentures, Net of Debt Discount of $173,650 and $608,737 at January 31, 2007 and July 31, 2006, respectively
   
81,488
   
160,494
 
Total Current Liabilities
   
5,250,368
   
6,033,343
 
               
Long-Term Debt, Net
   
2,798,222
   
2,608,105
 
               
Commitments and Contingencies
             
               
Stockholders’ Equity:
             
Special Voting Rights Preferred stock, $.001 par value; authorized, issued and outstanding 1,000 shares at January 31, 2007 and July 31, 2006
   
1
   
1
 
Common stock, $.001 par value; authorized 500,000,000 shares at January 31, 2007 and July 31, 2006; 108,274,731 and 107,398,360shares issued and outstanding, respectively
   
108,274
   
107,397
 
Additional paid-in capital
   
244,569,834
   
243,097,627
 
Deficit accumulated during the development stage
   
(197,348,991
)
 
(188,495,312
)
Accumulated other comprehensive income
   
654,872
   
754,081
 
Total Stockholders’ Equity
   
47,983,990
   
55,463,794
 
               
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
 
$
56,032,580
 
$
64,105,242
 
 
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
     
(Date of
 
   
Ended
 
For the Six Months Ended
 
Inception)
 
   
January 31,
 
January 31,
 
to January 31,
 
   
2007
 
2006
 
2007
 
2006
 
2007
 
                                 
Revenues
 
$
45,923
 
$
43,750
 
$
184,928
 
$
87,500
 
$
2,379,224
 
Sales Discounts
   
(502
)
 
   
(502
)
 
   
(502
)
Net Revenue
   
45,421
   
43,750
   
184,426
   
87,500
   
2,378,722
 
                                 
Cost of Goods Sold
   
21,466
   
   
52,981
   
   
52,981
 
                                 
Operating Expenses:
                               
Research and development
   
2,482,082
   
1,317,115
   
4,075,015
   
1,993,494
   
65,184,988
 
Research and development - related party
   
   
   
   
   
220,218
 
Selling
   
13,399
   
   
13,399
   
   
13,399
 
General and administrative
   
3,006,951
   
3,910,887
   
5,501,690
   
5,385,743
   
83,642,259
 
General and administrative - related party
   
   
   
   
   
314,328
 
Total Operating Expenses
   
5,502,432
   
5,228,002
   
9,590,104
   
7,379,237
   
149,375,192
 
                                 
Operating Loss
   
(5,478,477
)
 
(5,184,252
)
 
(9,458,659
)
 
(7,291,737
)
 
(147,049,451
)
                                 
Other Income (Expense):
                               
Miscellaneous income (expense)
   
   
500
   
   
500
   
196,193
 
Income from Rental Operations, net
   
52,462
   
30,987
   
86,935
   
35,840
   
406,298
 
Interest income
   
601,125
   
14,759
   
1,204,897
   
16,096
   
5,366,975
 
Interest expense
   
(248,437
)
 
(8,490,956
)
 
(506,027
)
 
(15,230,531
)
 
(42,934,403
)
Loss on extinguishment of debt
   
(122,307
)
 
(771,635
)
 
(180,825
)
 
(933,983
)
 
(14,077,731
)
                                 
Net Loss Before Undernoted
   
(5,195,634
)
 
(14,400,597
)
 
(8,853,679
)
 
(23,403,815
)
 
(198,092,119
)
                                 
Minority Interest Share of Loss
   
   
   
   
   
3,038,185
 
                                 
Net Loss
   
(5,195,634
)
 
(14,400,597
)
 
(8,853,679
)
 
(23,403,815
)
 
(195,053,934
)
                                 
Preferred Stock Dividend
   
   
   
   
   
2,295,057
 
                                 
Net Loss Available to Common Shareholders
 
$
(5,195,634
)
$
(14,400,597
)
$
(8,853,679
)
$
(23,403,815
)
$
(197,348,991
)
                                 
Basic and Diluted Net Loss Per Common Share
 
$
(.05
)
$
(.23
)
$
(.08
)
$
(.43
)
     
                                 
Weighted Average Number of Shares of Common Stock Outstanding
   
108,160,528
   
63,906,552
   
107,884,535
   
54,852,364
       
 
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,
 
   
 2007
 
2006
 
2007
 
Cash Flows From Operating Activities:
                   
Net loss
 
$
(8,853,679
)
$
(23,403,815
)
$
(195,053,934
)
Adjustments to reconcile net loss to net cash used in operating activities:
                   
Depreciation and amortization
   
577,206
   
566,445
   
5,293,062
 
Minority interest share of loss
   
   
   
(3,038,185
)
Reduction of notes receivable - common stock in exchange for services rendered
   
   
   
423,882
 
Write-off of uncollectible notes receivable - common stock
   
   
   
391,103
 
Write-off of deferred offering costs
   
   
   
3,406,196
 
Write-off of abandoned patents
   
3,097
   
1,278
   
152,882
 
Loss on disposal of property and equipment
   
   
   
911
 
Loss on extinguishment of debt
   
180,826
   
933,983
   
14,077,732
 
Common stock issued as employee compensation
   
183,000
   
   
1,728,504
 
Common stock issued for services rendered
   
354,389
   
54,071
   
5,655,692
 
Amortization of prepaid services in conjunction with common stock issuance
   
   
92,250
   
138,375
 
Non-cash compensation expense
   
   
   
45,390
 
Stock options and warrants issued for services rendered
   
   
7,300,145
   
7,006,323
 
Issuance of warrants as additional exercise right inducement
   
   
   
21,437,909
 
Preferred stock issued for services rendered
   
   
   
100
 
Treasury stock redeemed for non-performance of services
   
   
   
(138,000
)
Amortization of deferred debt issuance costs and loan origination fees
   
   
777,967
   
1,482,879
 
Amortization of discount on convertible debentures
   
435,087
   
6,943,339
   
18,756,777
 
Common stock issued as interest payment on convertible debentures
   
15,716
   
112,688
   
284,459
 
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
   
   
   
113,274
 
Changes in operating assets and liabilities (excluding the effects of acquisition):
                   
Accounts receivable
   
(110,104
)
 
   
(110,104
)
Miscellaneous receivables
   
   
   
43,812
 
Inventory
   
(44,087
)
 
   
(44,087
)
Other current assets
   
(177,291
)
 
49,118
   
(279,936
)
Accounts payable and accrued expenses
   
(341,258
)
 
2,097,117
   
9,304,661
 
Deferred revenue
   
15,475
   
   
15,475
 
Other, net
   
   
   
110,317
 
Net Cash Used in Operating Activities
   
(7,761,623
)
 
(4,461,890
)
 
(108,418,835
)
                     
Cash Flows From Investing Activities:
                   
Purchase of property and equipment
   
(77,208
)
 
(76,665
)
 
(4,519,915
)
Costs incurred for patents
   
(105,302
)
 
(16,959
)
 
(1,714,298
)
Change in restricted cash
   
   
60,721
   
45,872
 
Proceeds from maturity of short term investments
   
17,488,782
   
   
152,775,828
 
Purchases of short-term investments
   
(11,413,110
)
 
(6,000,000
)
 
(161,072,809
)
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
   
(176,092
)
 
   
(682,925
)
Change in notes receivable - common stock
   
   
   
(91,103
)
Change in due from related parties
   
   
   
(2,222,390
)
Other, net
   
   
   
89,683
 
Net Cash Provided by (Used in) Investing Activities
   
5,717,070
   
(6,032,903
)
 
(18,467,982
)
 
The Notes to Consolidated Financial Statements are an integral part of these statements.
 
3


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,
 
   
 2007
 
2006
 
2007
                     
Cash Flows From Financing Activities:
                   
Proceeds from short-term advance
   
   
   
325,179
 
Repayment of short-term advance
   
   
   
(347,369
)
Proceeds from issuance of long-term debt
   
   
   
2,005,609
 
Repayment of long-term debt
   
(34,773
)
 
(107,352
)
 
(1,813,991
)
Change in due to related parties
   
   
   
154,541
 
Proceeds from exercise of warrants
   
125,000
   
15,399,998
   
44,015,049
 
Proceeds from exercise of stock options
   
176,983
   
202,790
   
4,429,178
 
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
   
20,254,930
 
Repayments of convertible debentures
   
(76,923
)
 
   
(538,281
)
Purchase of treasury stock
   
   
   
(483,869
)
Proceeds from issuance of common stock, net
   
   
   
80,283,719
 
Purchase and retirement of common stock
   
   
   
(119,066
)
Net Cash Provided by Financing Activities
   
190,287
   
25,450,436
   
163,218,814
 
                     
Effect of Exchange Rates on Cash
   
(13,025
)
 
9,911
   
9,205
 
                     
Net Increase (Decrease) in Cash and Cash Equivalents
   
(1,867,291
)
 
14,965,554
   
36,341,202
 
                     
Cash and Cash Equivalents, Beginning of Period
   
38,208,493
   
586,530
   
 
                     
Cash and Cash Equivalents, End of Period
 
$
36,341,202
 
$
15,552,084
 
$
36,341,202
 
 
The Notes to Consolidated Financial Statements are an integral part of these statements.
 
4

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 2007. In the Company’s opinion all adjustments necessary for a fair presentation of these interim statements have been included and are of a normal and recurring nature.

The Company is in the development stage and has realized minimal revenues to date. The Company currently has one commercial product, Glucose RapidSprayTM, which has generated revenue commencing during the six months ended January 31, 2007. 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.
Summary of Significant Accounting Policies

Accounts Receivable
 
Accounts receivable are customer obligations due under normal trade terms. The Company sells its product to various distributors and retailers. The Company performs ongoing credit evaluations of customers’ financial condition and does not require collateral.
 
Management reviews accounts receivable on a monthly basis to determine collectibility. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. The allowance for doubtful accounts contains a general accrual for estimated bad debts and had a balance of $-0- at January 31, 2007 and July 31, 2006, however, actual write-offs may exceed the allowance.

Inventory
 
Inventories consist primarily of Glucose RapidSprayTM product and components. Inventories are stated at the lower of cost or market with cost determined using the first-in first-out (“FIFO”) method. In evaluating whether inventory is stated at the lower of cost or market, management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time required to sell such inventory, remaining shelf life and current and expected market conditions, including levels of competition. As appropriate, a provision is recorded to reduce inventories to their net realizable value.
 
5


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

Revenue Recognition
 
Revenues are recognized when the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred; (iii) the price to the customer is fixed or determinable; and (iv) collection of the sales price is reasonably assured. Delivery occurs when goods are shipped and title and risk of loss transfer to the customer, in accordance with the terms specified in the arrangement with the customer. Revenue recognition is deferred in all instances where the earnings process is incomplete. Certain product sales are made to retailers under agreements allowing for a right to return unsold products. In accordance with SFAS No. 48, “Revenue Recognition When Right of Return Exists (as amended)” recognition of revenue on all sales to these retailers is deferred until the right of return expires, the product is sold to a third party or a provision for returns can be reasonably estimated based on historical experience. The cost of inventory under these sales is considered to be a consigned inventory until the revenue is recognized.

3.
Effects of Recent Accounting Pronouncements
 
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.

In March 2006, the FASB issued SFAS No. 156, “Accounting for Servicing of Financial Assets”, to simplify accounting for separately recognized servicing assets and servicing liabilities. SFAS No. 156 amends SFAS No. 140, “Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities. Additionally, SFAS No. 156 permits, but does not require, an entity to choose either the amortization method or the fair value measurement method for measuring each class of separately recognized servicing assets and servicing liabilities. SFAS No. 156 applies to all separately recognized servicing assets and servicing liabilities acquired or issued after the beginning of an entity’s fiscal year that begins after September 15, 2006, although early adoption is permitted. The Company does not expect that the adoption of SFAS No. 156 will have a significant impact on the consolidated results of operations or financial position of the Company.

In July 2006, FASB has published FASB Interpretation No. 48 (FIN No. 48), “Accounting for Uncertainty in Income Taxes”, to address the noncomparability in reporting tax assets and liabilities resulting from a lack of specific guidance in SFAS No. 109, “Accounting for Income Taxes”, on the uncertainty in income taxes recognized in an enterprise’s financial statements.  FIN No. 48 will apply to fiscal years beginning after December 15, 2006, with earlier adoption permitted.  The Company does not expect that the adoption of FIN No. 48 will have a significant impact on the consolidated results of operations or financial position of the Company.
 
6


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

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,”  to eliminate the diversity in practice that exists due to the different definitions of fair value and the limited guidance for applying those definitions in GAAP that are dispersed among the many accounting pronouncements that require fair value measurements. SFAS No. 157 retains the exchange price notion in earlier definitions of fair value, but clarifies that the exchange price is the price in an orderly transaction between market participants to sell an asset or liability in the principal or most advantageous market for the asset or liability. Moreover, the SFAS states that the transaction is hypothetical at the measurement date, considered from the perspective of the market participant who holds the asset or liability. Consequently, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (an exit price), as opposed to the price that would be paid to acquire the asset or received to assume the liability at the measurement date (an entry price).

SFAS No. 157 also stipulates that, as a market-based measurement, fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability, and establishes a fair value hierarchy that distinguishes between (a) market participant assumptions developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (b) the reporting entity's own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). Finally, SFAS No. 157 expands disclosures about the use of fair value to measure assets and liabilities in interim and annual periods subsequent to initial recognition. Entities are encouraged to combine the fair value information disclosed under SFAS No. 157 with the fair value information disclosed under other accounting pronouncements, including SFAS No. 107, “Disclosures about Fair Value of Financial Instruments,” where practicable. The guidance in this Statement applies for derivatives and other financial instruments measured at fair value under SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities,” at initial recognition and in all subsequent periods.

SFAS No. 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years, although earlier application is encouraged. Additionally, prospective application of the provisions of SFAS No. 157 is required as of the beginning of the fiscal year in which it is initially applied, except when certain circumstances require retrospective application. The Company is currently evaluating the impact of this statement on its results of operations or financial position of the Company.

In September 2006, the FASB issued “Statement of Financial Accounting Standards No. 158, Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans (an amendment of FASB Statements No. 87, 88, 106, and 132R)”, which will require employers to fully recognize the obligations associated with single-employer defined benefit pension, retiree healthcare and other postretirement plans in their financial statements. Under past accounting standards, the funded status of an employer’s postretirement benefit plan (i.e., the difference between the plan assets and obligations) was not always completely reported in the balance sheet. Past standards only required an employer to disclose the complete funded status of its plans in the notes to the financial statements. SFAS No. 158 applies to plan sponsors that are public and private companies and nongovernmental not-for-profit organizations. The requirement to recognize the funded status of a benefit plan and the disclosure requirements are effective as of the end of the fiscal year ending after December 15, 2006, for entities with publicly traded equity securities, and at the end of the fiscal year ending after June 15, 2007, for all other entities. The requirement to measure plan assets and benefit obligations as of the date of the employer’s fiscal year-end statement of financial position is effective for fiscal years ending after December 15, 2008. The Company does not expect that the adoption of SFAS No. 158 will have a significant impact on the consolidated results of operations or financial position of the Company.
 
7


GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
 
In February 2007, the FASB issued SFAS No. 159, “Establishing the Fair Value Option for Financial Assets and Liabilities” to permit all entities to choose to elect to measure eligible financial instruments at fair value. The decision whether to elect the fair value option may occur for each eligible item either on a specified election date or according to a preexisting policy for specified types of eligible items. However, that decision must also take place on a date on which criteria under SFAS 159 occurs. Finally, the decision to elect the fair value option shall be made on an instrument-by-instrument basis, except in certain circumstances.
 
An entity shall report unrealized gains and losses on items for which the fair value option has been elected in earnings at each subsequent reporting date, and recognize upfront costs and fees related to those items in earnings as incurred and not deferred.
 
SFAS No. 159 applies to fiscal years beginning after November 15, 2007, with early adoption permitted for an entity that has also elected to apply the provisions of SFAS No. 157 , Fair Value Measurements. An entity is prohibited from retrospectively applying SFAS No. 159, unless it chooses early adoption. SFAS No. 159 also applies to eligible items existing at November 15, 2007 (or early adoption date).

4.
Stock-Based Compensation
 
As of January 31, 2007, 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 1,900,000 and 1,047,490 shares of common stock reserved for future awards under the 2000 Plan and 2001 Plan, respectively, as of January 31, 2007.

The 2000 and 2001 Plans (the Plans) are administered by the Compensation Committee (the Committee). The Committee 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 Committee 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 Committee.

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.

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 typically 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 six months ended January 31, 2007.
 
8


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

The summary of the stock option activity for the six months ended January 31, 2007 is as follows:

   
 
 
Weighted
 
Weighted
 
 
 
 
 
 
 
Average
 
Average
 
 
 
 
 
 
 
Exercise
 
Remaining
 
Aggregate
 
 
 
 
 
Price
 
Contractual
 
Instrinsic
 
 
 
Shares
 
Share
 
Term (Years)
 
Value
 
                           
Outstanding, August 1, 2006
   
8,429,597
 
$
1.15
             
Granted
   
 
$
             
Cancelled
   
(185,159
)
$
8.08
             
Exercised
   
(111,800
)
$
1.58
             
Outstanding, January 31, 2007
   
8,132,638
 
$
0.99
   
2.33
 
$
6,792,983
 
Exercisable, January 31, 2007
   
8,132,638
 
$
0.99
   
2.33
 
$
6,792,983
 

Grant Date Fair of Cancelled Options
 
$
5.85
 
Total Intrinsic Value of Options Exercised
 
$
64,329
 
 
The Company had no non-vested stock options outstanding as of January 31, 2007 and July 31, 2006. Accordingly, there was no unrecognized compensation related to non-vested stock options granted under the Company’s stock option plans.

5.
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, 2007 and 2006, was $5,312,527 and $14,341,265, respectively, and for the six months ended January 31, 2007 and 2006, was $8,952,888 and $23,255,826, respectively.

6.
Accounts Payable and Accrued Expenses
 
Accounts payable and accrued expenses consist of the following:

   
January 31,
 
July 31,
 
 
 
2007
 
2006
 
               
Accounts Payable
 
$
1,448,497
 
$
624,543
 
Research and Development
   
630,601
   
696,769
 
Executive Compensation
   
1,588,730
   
2,121,389
 
Financial Services
   
1,411,938
   
1,411,938
 
Total
 
$
5,079,766
 
$
5,444,790
 

9


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

7.
Convertible Debentures
 
The convertible debentures are accounted for in accordance with EITF 98-5 and 00-27. The following summarizes the significant terms and accounting for each convertible debenture entered into by the Company.

   
Debenture
 
 
 
3rd $4,000,000
 
Date Issued
   
2/2006
 
Promissory Note Amount
 
$
1,000,000
 
# of Promissory Notes
   
4
 
Terms
   
(A
)
Conversion Price
 
$
1.25
 
         
Gross Proceeds
 
$
4,000,000
 
Net Cash Proceeds
 
$
4,000,000
 
Warrants Issued to Investor
   
3,200,000
 
Warrant Exercise Price
 
$
1.25
 
Warrant Fair Value (WFV)
 
$
2,374,507
 
Black Scholes Model Assumptions
   
(B1
)
Beneficial Conversion Feature (BCF)
 
$
1,625,493
 
         
Amortization of WFV and BCF as Non-cash Interest Expense
       
$3,826,350
       
         
Principal and Interest Converted
 
$
2,923,894
 
Loss on Extinguishment (C)
 
$
2,393,964
 
Shares Issued Upon Conversion
   
2,322,635
 
         
Principal and Interest Repayments in Shares of Common Stock
 
$
941,326
 
Loss on Extinguishment (C)
 
$
571,782
 
Shares Issued for Principal and Interest Repayments
   
641,813
 
Principal and Interest Repayments in Cash
 
$
76,923
 

As of January 31, 2007, the $81,488 net outstanding balance of convertible debentures is comprised of $255,138 of debt net of unamortized debt discount of $173,650 related to the 3rd $4,000,000 convertible debentures. All other convertible debentures have either been repaid or converted to shares of common stock and the related debt discounts have been fully amortized.

(A)
The notes carry a 6% coupon and a 15-month term and amortization in 13 equal assignments commencing in the third month of the term. 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 predetermined conversion price, subject to certain conditions.

(B)
Black Scholes pricing model assumptions:
 
Risk Free
 
Expected
 
Life
 
Interest Rate
 
Volatility
 
(Years)
 
           
4.49%
   
0.9380
   
5.50
 
 
10

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

(C)
Loss on extinguishment represents the difference between the quoted market price of the Company's common stock and lower of predetermined conversion price or the 10% discount to the average of the 20-day VWAP.

8.
Pending Litigation  
 
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 September, 2006, The Shemano Group, Inc. (“Shemano”), a San Francisco-based investment banking firm, commenced an arbitration proceeding against the Company before the National Association of Securities Dealers (the “NASD”) alleging entitlements to cash and warrant compensation under a November 1, 2004 finder’s agreement in respect of certain subsequent financing transactions concluded by the Company. The Company has since filed an answer with the NASD. The arbitration hearing has been scheduled for June 2007. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time.
 
11


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

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 and six months ended January 31, 2007 and 2006 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 23,647,730 and 37,791,029 incremental shares at January 31, 2007 and 2006, respectively, have been excluded from the computation of Diluted EPS as they are anti-dilutive.

10.
Supplemental Disclosure of Cash Flow Information

   
For the Six Months Ended
 January 31,
 
   
2007
 
2006
 
Cash paid during the period for:
             
Interest
 
$
137,696
 
$
56,427
 
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
 
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
 
Satisfaction of accounts payable through the issuance of common stock
 
$
 
$
133,605
 
Principal repayment of convertible debentures through the issuance of common stock
 
$
384,616
 
$
1,075,794
 
Issuance of common stock in conjunction with convertible debenture conversion
 
$
52,554
 
$
6,963,007
 
 
12


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

11.
Stockholders’ Equity
 
During the six months ended January 31, 2007, the Company issued an aggregate of 320,266 shares of common stock as monthly principal and interest payments totaling $560,557 and 42,043 shares of common stock upon the conversion of $73,155 in principal of convertible debentures (see Note 7).

During the six months ended January 31, 2007, the Company issued 202,262 shares of common stock to various consultants for services rendered in the amount of $354,389. The shares were valued at $1.43 to $2.15 per share based on the quoted market price of the Company’s common stock on the dates of the issuances.

During the six months ended January 31, 2007, the Company issued 100,000 shares of common stock valued at $183,000 as employee compensation based on the quoted market price of the Company’s common stock on the dates of the issuances.

During the six months ended January 31, 2007, the Company received aggregate cash proceeds of $176,982 from exercises of stock options. The Company issued 111,800 shares of common stock as a result of these transactions.

During the six months ended January 31, 2007, the Company received aggregate cash proceeds of $125,000 from exercises of stock warrants. The Company issued 100,000 shares of common stock as a result of these transactions.

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 Monthly Repayments
   
320,266
 
$
320
 
$
560,237
 
$
560,557
 
Convertible Debenture Conversions
   
42,043
   
42
   
73,113
   
73,155
 
Warrants and Stock Options Exercised for Cash
   
211,800
   
212
   
301,770
   
301,982
 
Issuance for Services
   
202,262
   
202
   
354,187
   
354,389
 
Issuance as Employee Compensation
   
100,000
   
100
   
182,900
   
183,000
 
                           
Total
   
876,371
 
$
876
 
$
1,472,207
 
$
1,473,083
 
 
13


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

As used herein, the terms the “Company,” “Generex,” “we,” “us,” or “our” refer to Generex Biotechnology Corporation, a Delaware corporation. The following discussion and analysis by management provides information with respect to our financial condition and results of operations for the three- and six-month periods ended January 31, 2007. This discussion should be read in conjunction with the information contained in Part I, Item 1A - Risk Factors and Part II, Item 8 - Financial Statements and Supplementary Data in our Annual Report on Form 10-K for the year ended July 31, 2006, as amended, and the information contained in Part I, Item 1 - Financial Statements and Part II, Item 1A- Risk Factors in this Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2007.

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, 2007 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," “anticipates,” "projects," “predicts,” “foresees” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Our forward-looking statements address, among other things:

 
·
our expectations concerning product candidates for our technologies;
     
 
·
our expectations concerning existing or potential development and license agreements for third-party collaborations and joint ventures;
     
 
·
our expectations of when different phases of clinical activity may commence and conclude;
     
 
·
our expectations of when regulatory submissions may be filed or when regulatory approvals may be received; and
     
 
·
our expectations of when commercial sales of our products may commence and when actual revenue from the product sales may be received.

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

 
·
the inherent uncertainties of product development based on our new and as yet not fully proven technologies;
     
 
·
the risks and uncertainties regarding the actual effect on humans of seemingly safe and efficacious formulations and treatments when tested clinically;
     
 
·
the inherent uncertainties associated with clinical trials of product candidates;
     
 
·
the inherent uncertainties associated with the process of obtaining regulatory approval to market product candidates;
     
 
·
the inherent uncertainties associated with commercialization of products that have received regulatory approval; and
     
 
·
our ability to obtain the necessary financing to fund our operations.
 
Additional factors that could affect future results are set forth in Part I, Item 1A Risk Factors of our Annual Report on Form 10-K for the year ended July 31, 2006, as amended, and in Part II, Item 1A. Risk Factors of this Quarterly Report on Form 10-Q. We caution investors that the forward-looking statements contained in this Quarterly Report must be interpreted and understood in light of conditions and circumstances that exist as of the date of this Quarterly Report. We expressly disclaim any obligation or undertaking to update or revise forward-looking statements to reflect any changes in management's expectations resulting from future events or changes in the conditions or circumstances upon which such expectations are based.
 
14


Executive Summary

About the Company

We are engaged primarily in the research, development, and commercialization of drug delivery systems and technologies. Our primary focus at the present time is our proprietary technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity. In our wholly-owned subsidiary, Antigen Express, Inc., we focus on immunomedicines. We operate in only one segment: the research, development and commercialization of drug delivery systems and technologies for metabolic and immunological diseases.

We are a development stage company and, from inception through the end of the 2006 fiscal year, had not received any revenues from operations other than the $1,000,000 upfront payment which we received from Eli Lilly and Company pursuant to a development and license agreement that we entered into in September 2000 and subsequently terminated as of June 2003. In the quarterly period ended January 31, 2007, we realized revenue of approximately $45,000 from sales of our confectionary, Glucose RapidSpray™, which we introduced in August 2006 and which is currently available in retail stores and independent pharmacies in the United States and Canada. We have entered into distribution agreements with Cardinal Health, AmerisourceBergen Corporation and McKesson Canada for the distribution of Glucose RapidSpray™ in retail stores in the United States and Canada and have received purchase orders from Shoppers Drug Mart, Meijer, Inc., Kerr Drug, Inc., Hy-Vee, Inc., and Fruth Pharmacy, Inc. We expect to procure additional distribution arrangements with wholesalers and retail chains to distribute this product in other stores throughout the United States and Canada. In December 2006, we entered into a letter of intent with Inyx, Inc. pursuant to which Inyx would be the exclusive manufacturer of Glucose RapidSpray™ except in Canada and Ecuador. We anticipate that the manufacturing agreement with Inyx will extend for three years.

We have begun the regulatory approval process for five products: our oral insulin formulation (late-stage), our oral morphine formulation (pre-clinical), the Antigen HER-2/neu positive breast cancer vaccine (Phase II), the Antigen avian influenza vaccine (Phase I), and the Antigen prostate cancer vaccine (Phase I). Our oral insulin formulation, Generex Oral-lyn™, was approved for commercial marketing and sale in Ecuador in May 2005 and is presently available for sale there. Our business partner for the commercialization of Generex Oral-lyn™ in Latin America, PharmaBrand S.A., is responsible for the commercial sales of Generex Oral-lyn™ in Ecuador and expects additional commercial manufacturing runs of the product at its facilities in Quito, Ecuador in 2007. We expect to receive the revenues from the sale of Generex Oral-lyn™ in Ecuador during this fiscal year.

Our organizational structure consists of Generex Biotechnology Corporation and five wholly-owned subsidiaries: Generex Pharmaceuticals Inc., which is incorporated in Ontario, Canada and which performs all of our Canadian operations; Generex (Bermuda), Inc., which is incorporated in Bermuda and which currently does not conduct any business activities; Antigen Express, Inc., which is incorporated in Delaware and which we acquired in 2003; Generex Pharmaceuticals (USA) LLC, which we organized in North Carolina in February 2006 and which has not yet commenced any business operations; and Generex Marketing & Distribution Inc., which we organized in Ontario, Canada in September 2006 and which has not yet commenced any business operations.

Strategy

With the launch of commercial sales of our oral insulin product in Ecuador and our oral glucose product in retail chains and independent pharmacies in the United States and Canada, we have received revenues from product sales in fiscal 2007. We project that this revenue will not 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 first half of fiscal 2007, we received a total of $72,917 in such research grants, and we have received a total of $1,192,123 in such research grants. We do not expect to receive such grants on a going forward basis.
 
15


We expect to satisfy a portion of our cash needs during the current year from previous capital raised through equity and debt financings with a limited group of investors. We believe that the terms of such financings were favorable to us. Through the financing transactions that we closed in our last two fiscal years, we believe that we have secured the funds necessary to continue in the short term with the commercialization of Generex Oral-lyn™ in Ecuador, to seek regulatory approval for this product in certain other Latin American countries and to pursue late-stage clinical trials of this product in Canada, the United States and Europe. We also project that we will have funds in the short term to support further research and development and clinical testing of the Antigen Express vaccine technologies.

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 Food and Drug Administration or other regulatory approvals are obtained. Management plans to meet our operating cash flow requirements through financing activities, such as private placement of our common stock, preferred stock offerings and offerings of debt and convertible debt instruments. We have filed a shelf registration statement with the Securities and Exchange Commission (“SEC”) to register an indeterminate number of shares of common stock and preferred stock and an indeterminate number of warrants and units, the aggregate initial offering price of which is not to exceed $150,000,000. Management is also actively pursuing industry collaboration activities, including product licensing and specific project financing.
 
In fiscal 2007, we plan to continue with the commercialization of Generex Oral-lyn™ in Ecuador and efforts to obtain regulatory approval of this product in other Latin American countries, Canada, the United States and Europe. In September 2006 a Clinical Trial Application relating to our Generex Oral-lyn™ protocol for late-stage trials was approved by Health Canada. We anticipate being in a position to commence patient dosing in fall of 2007. In anticipation of undertaking late-stage clinical trials in Canada, we have secured a manufacturer to produce clinical trial batches of Generex Oral-lyn™.

We face competition from other providers of alternate forms of insulin, including Pfizer which could capture a large portion of the market with its inhalable form of insulin, marketed as Exubera®, initial supplies of which became available in the U.S. in September 2006. We understand that an expanded roll-out of Exubera® to primary-care physicians and direct-to-consumer advertising in the U.S., which Pfizer previously targeted for November 2006, is now scheduled to begin in the second half of 2007. We believe that our buccal delivery technology offers several advantages over alternate forms of insulin.

In fiscal 2007, we expect to continue collaborations to develop other products. We will continue joint development activities with Fertin Pharma A/S with respect to a metformin medicinal chewing gum for the treatment of Type-2 diabetes mellitus and obesity. In late 2006, we obtained our first foreign patent covering our medicinal gum platform. We expect to continue clinical development of Antigen’s synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with stage II HER-2/neu positive breast cancer and patients with prostate cancer and against avian influenza. In November 2006, we entered into an agreement with the Lebanese-Canadian Hospital in Beruit, Lebanon to conduct a clinical trial of the Antigen synthetic avain influenza vaccine. In February 2007, in conjunction with the United States Military Cancer Institute’s Clinical Trials Group, we entered into a Phase II clinical trial using the Antigent peptide vaccine in breast cancer patients who have completed standard therapy for node-positive or high-risk node-negative breast cancer expressing at least low levels of the HER-2/neu oncogene and who are at increased risk for recurrence.

Accounting for Research and Development Projects

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

During the past six months, we expended resources on the clinical testing and commercialization, of our buccal insulin product, Generex Oral-lyn™. In September 2006, our Clinical Trial Application with Health Canada for the commencement of late-stage trials for Generex Oral-lyn™ was approved by Health Canada. Late-stage trials of this product will involve tests with a large number of patients over a significant period of time. The completion of late-stage trials in Canada, Europe and the United States may require significantly greater funds than we currently have on hand.
 
16


Generex Oral-lyn™ was approved for commercial sale by drug regulatory authorities in Ecuador in May 2005. Our South American business partner, PharmaBrand S.A., completed the first commercial production run of Generex Oral-lyn™ in Ecuador in June, 2006. During the six months ended January 31, 2007, we and PharmaBrand have implemented education, marketing and training programs for physicians in Ecuador to support sales of Generex Oral-lyn™, which is available through physician referrals and pharmacies. While we anticipate generating revenue from sales of Generex Oral-lyn™ in Ecuador in fiscal 2007, we do not expect that such revenues will be sufficient to sustain our research and development and regulatory activities in Latin America.

Although we initiated regulatory approval process for our morphine buccal product, we did not expend resources to further this product during the six-month period ended January 31, 2007.

During the six months ended January 31, 2007, we expended resources on research and development relating to Antigen’s peptide immunotherapeutic vaccines and related technologies. One Antigen vaccine is currently in Phase II clinical trials involving patients with HER-2/neu positive breast cancer. We expect to begin clinical trials in Greece in the third quarter of fiscal 2007 with the same compound as an immunotherapeutic vaccine for prostate cancer. In addition, we have selected volunteers in January 2007 to be included in clinical trials of a synthetic immunotherapeutic vaccine for avian influenza in Lebanon in fiscal 2007.

Because of various uncertainties, we cannot predict the timing of completion and commercialization of our buccal insulin or buccal morphine products or Antigen’s peptide immunotherapeutic vaccines or related technologies. These uncertainties include the success of current studies, our ability to obtain the required financing and the time required to obtain regulatory approval even if our research and development efforts are completed and successful. For the same reasons, we cannot predict when any products may begin to produce net cash inflows.

Most of our buccal delivery research and development activities to date have involved developing our platform technology for use with insulin and morphine. Insubstantial amounts have been expended on projects with other drugs, and those projects involved a substantial amount of platform technology development. As a result, we have not made significant distinctions in the accounting for research and development expenses among products, as a significant portion of all research has involved improvements to the platform technology in connection with insulin, which may benefit all of our potential buccal products. During the six months ended January 31, 2007, approximately 69% of our $4,075,015 in research expenses was attributable to insulin and platform technology development, and we did not have any research expenses related to morphine or other buccal projects. During the six months ended January 31, 2006, approximately 74% of our $1,993,494 in research expenses was attributable to insulin and platform technology development, and we did not spend any money on morphine or fentanyl buccal projects.

Approximately 31% or $1,242,950 of our research and development expenses for the six months ended January 31, 2007 was related to Antigen's immunomedicine products compared to approximately 26% or $512,466 for the same period last year. Because these products are in the pre-clinical or Phase I stages of development (with the exception of the Antigen HER-2/neu positive breast cancer vaccine for which Phase II clinical trials have been initiated), 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 this technology, or when products from this technology might begin producing revenues.

Results of Operations
 
Three Months Ended January 31, 2007 Compared to Three Months Ended January 31, 2006

Our net loss for the quarter ended January 31, 2007 was $5,195,634 versus $14,400,597 in the corresponding quarter of the prior fiscal year. The decrease in net loss in this fiscal quarter versus the corresponding quarter of the prior fiscal year is primarily due to the decrease in interest expense and loss on extinguishment of debt incurred in connection with convertible debentures entered into during the 2006 fiscal year. Our operating loss for the quarter increased to $5,478,477 compared to $5,184,252 in the second fiscal quarter of 2006. The increase resulted from an increase in research and development expenses (to $2,482,082 from $1,317,115) despite a slight decrease in general and administrative expenses (to $3,006,951 from $3,910,887). Our net revenues decreased slightly from $43,750 in the quarter ended January 31, 2006 to $45,421 in the quarter ended January 31, 2007.

The increase in research and development expenses for the quarter ended January 31, 2007 reflects an increased level of research and development of our oral insulin product and platform technology and additional clinical trials and increased research and development efforts of Antigen. The decrease in general and administrative expenses is due primarily to the decrease in cash and non cash compensation to financial and other consultants and decrease in bonus compensation paid to executive officers.
 
17


Our interest expense in the fiscal quarter ended January 31, 2007 decreased to $248,437 compared to interest expense of $8,490,956 in the fiscal quarter ended January 31, 2006 due to smaller number of convertible debentures still outstanding and none entered into during fiscal 2007. Our loss on extinguishment of debt, also incurred in connection with convertible debentures, was $122,307 in the fiscal quarter ended January 31, 2007 compared to $771,635 in the same quarter for the last fiscal year. Our interest income increased to $601,125 in the fiscal quarter ended January 31, 2007 compared to $14,759 in the same quarter for the last fiscal year primarily due to substantially higher cash and short term investment balances during the current fiscal quarter. We received a slightly higher income from rental operations (net of expense) of $52,462 in the fiscal quarter ended January 31, 2007 compared to $30,987 in the same quarter for the last fiscal year.

Results of Operations
 
Six Months Ended January 31, 2007 Compared to Six Months Ended January 31, 2006

Our net loss for the six months ended January 31, 2007 was $8,853,679 versus $23,403,815 in the corresponding six-month period of the prior fiscal year. The decrease in net loss in this six-month period versus the corresponding six-month period of the prior fiscal year is primarily due to the decrease in interest expense and loss on extinguishment of debt incurred in connection with convertible debentures entered into during the 2006 fiscal year. Our operating loss for the six months ended January 31, 2007 increased to $9,458,659 compared to $7,291,737 in the corresponding six-month period ended January 31, 2006. The increase resulted from an increase in research and development expenses (to $4,075,015 from $1,993,494) and slight increases in general and administrative expenses (to $5,501,690 from $5,385,743) and selling expenses (to $13,399 from $0). Our net revenues increased to $184,426 in the six months ended January 31, 2007 from $87,500 in the six months ended January 31, 2006. The increase in net revenues is attributable to sale of Glucose RapidSpray™.

The increase in research and development expenses for the six-month period ended January 31, 2007 reflects an increased level of research and development of our oral insulin product and platform technology and additional clinical trials and increased research and development efforts of Antigen. The increase in general and administrative expenses reflects the increase in accounting, legal financial, consulting, advertising and travel expenses. The increase was significantly offset by the reduction in executive compensation in connection with the cash and non cash bonuses paid to executive officers last year. The selling expenses are associated with the commercial sales of Glucose RapidSpray™ that began in fiscal 2007 and were absent last year.

Our interest expense in the six-month period ended January 31, 2007 decreased to $506,027 compared to interest expense of $15,230,531 in the six-month period ended January 31, 2006 due to smaller number of convertible debentures still outstanding and none entered into during fiscal 2007. Our loss on extinguishment of debt, also incurred in connection with convertible debentures, was $180,825 in the six-month period ended January 31, 2007 compared to $933,983 in the corresponding period in the last fiscal year. Our interest income increased to $1,204,897 in the six-month period ended January 31, 2007 compared to $16,096 in the same period in the last fiscal year primarily due to substantially higher cash and short term investment balances during the current six-month period. We received a slightly higher income from rental operations (net of expense) of $86,935 in the six months ended January 31, 2007 compared to $35,840 in the six months ended January 31, 2006.

Developments

As of October 2006, we had received new purchase orders for Glucose RapidSpray™ from retail pharmacies, including Meijer, Inc., Kerr Drug, Inc., Hy-Vee, Inc., and Fruth Pharmacy, Inc.

In November, 2006, we entered into an agreement with the Lebanese-Canadian Hospital in Beirut, Lebanon to conduct a human clinical trial of a synthetic avian influenza vaccine developed by Antigen Express, representing the first studies to be conducted in humans. This vaccine is based upon peptide-synthesis technology which we believe can be manufactured rapidly, easily and at inexpensive cost. The study is being undertaken with the approval of the appropriate Lebanese governmental and regulatory bodies.
 
18


In December 2006, we entered into a letter of intent with Inyx, Inc. pursuant to which Inyx would be the exclusive manufacturer of Glucose RapidSpray™ except in Canada and Ecuador. We anticipate that the manufacturing agreement with Inyx will extend for three years.

In February 2007, in conjunction with the United States Military Cancer Institute’s Clinical Trials Group, we entered into a Phase II clinical trial using the Antigent peptide vaccine in breast cancer patients who have completed standard therapy for node-positive or high-risk node-negative breast cancer expressing at least low levels of the HER-2/neu oncogene and who are at increased risk for recurrence.

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.

At January 31, 2007, we had cash and short-term investments of approximately $44.5 million, a decrease of $7.9 million from the balance as of the end of the prior fiscal year. As of January 31, 2007, we believed that our anticipated cash position was sufficient to meet our working capital needs for the next twelve months based on the pace of our planned activities. Beyond that, we may require additional funds to support our working capital requirements or for other purposes. Management plans to meet our operating cash flow requirements through financing activities, such as private placement of our common stock, preferred stock offerings and offerings of debt and convertible debt instruments. Management is also actively pursuing industry collaboration activities, including product licensing and specific project financing. While we have generally been able to raise equity capital as required, our cash balances were very low during parts of 2005 and 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. 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, 2007, we had 6% secured convertible debentures outstanding in the aggregate principal amount of $255,138, which were issued in connection with the Securities Purchase Agreement dated November 10, 2004 and the amendments thereto. The outstanding 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 (May 1, 2006). 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) $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 debenture, the principal amount outstanding under each such debenture is initially convertible into shares of our common stock at a conversion price of $1.25.

Upon the occurrence of an “Event of Default” with respect to each debenture, the full principal amount of each such debenture, together with interest and other amounts owing in respect thereof, may be accelerated at the holder’s option 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 a debenture shall equal the sum of (i) the greater of: (A) 130% of the principal amount of the debentures to be prepaid, plus all accrued and unpaid interest thereon, or (B) the principal amount of the 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 debentures. The interest rate on the 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 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 debentures from the due date to the date of payment.
 
19


Since November 2004, we have issued an aggregate of 20,454,849 shares of common stock resulting from the conversion and repayment of an aggregate of $17,456,232 of debenture principal and accrued interest issued under the auspices of the Securities Purchase Agreement dated November 10, 2004 and amendments thereto.
As of January 31, 2007, warrants issued under the auspices of the Securities Purchase Agreement dated November 10, 2004 and amendments thereto were exercised to purchase an aggregate of 34,385,904 shares of our common stock at varying exercise prices for aggregate proceeds to us of $35,092,210.

All of the shares issued upon the conversion and repayment of debentures and exercise of warrants have been registered with the SEC for resale by the investors.

At January 31, 2007, the following warrants issued under the auspices of the Securities Purchase Agreement dated November 10, 2004 and amendments thereto and the Securities Purchase Agreement dated June 1, 2006 were outstanding:

Date Issued
 
Aggregate
No. of Shares Unexercised
 
Exercise Price*
 
Exercise Date
 
Expiration Date
 
January 26, 2006
   
522,226
 
$
1.60
   
June 2, 2006
   
July 22, 2011
 
February 27, 2006
   
4,770,617
 
$
3.00
   
August 27, 2006
   
August 27, 2011
 
February. 28, 2006
   
272,120
 
$
1.25
   
August 31, 2006
   
August 31, 2011
 
March 1, 2006
   
800,000
 
$
3.00
   
September 6, 2006
   
September 6, 2011
 
June 1, 2006
   
2,560,980
 
$
2.45
   
June 1, 2006
   
June 1, 2011
 
June 2, 2006
   
3,273,144
 
$
2.35
   
June 2, 2006
   
June 2, 2011
 

*subject to anti-dilution adjustments upon issuance of securities at a price per share of common stock less than the then applicable exercise price or the market price of our common stock at that time, whichever is lower

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:

Revenue Recognition. Net sales of Glucose RapidSpray™ are generally recognized in the period in which the products are delivered. Delivery of the products generally completes the criteria for revenue recognition for the Company. The Company provides certain customers the right of return for which the Company estimates and records as an offset against revenue.

Inventory. Inventories are stated at the lower cost or market with cost determined using the first-in first-out method. Management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time to sell such inventory, inventories shelf life and current market conditions when determining whether lower cost or market is used. As appropriate, a provision is recorded to reduce inventories to their net realizable value.

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.
 
20


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 we do not have any non-consolidated special purpose entities.

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
   
3,126,999
   
394,781
   
1,776,000
   
956,217
   
0
 
Capital Lease Obligations
   
0
   
0
   
0
   
0
   
0
 
Operating Lease Obligations
   
107,709
   
24,846
   
77,070
   
5,793
   
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
 
$
3,234,708
 
$
419,627
 
$
1,853,070
 
$
962,010
 
$
0
 

Related Party Transactions

On May 3, 2001, we advanced $334,300 to each of three senior officers, who are also our stockholders, in exchange for promissory notes. These notes bore interest at 8.5% per annum and were payable in full on May 1, 2002. These notes were guaranteed by a related company owned by these officers and secured by a pledge of 2,500,000 shares of our common stock owned by this related company. On June 3, 2002, our Board of Directors extended the maturity date of the loans to October 1, 2002. The other terms and conditions of the loans and guaranty remained unchanged and in full force and effect. As of July 31, 2002, the balance outstanding on these notes, including accrued interest, was $1,114,084. Pursuant to a decision made by the Compensation Committee as of August 30, 2002, these loans were satisfied through the application of 592,716 shares of pledged stock, at a value of $1.90 per share, which represented the lowest closing price during the sixty days prior to August 30, 2002.

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 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.
 
21


On August 7, 2002, we purchased real estate with an aggregate purchase price of approximately $1.6 million from an unaffiliated party. In connection with that transaction, Angara Enterprises, Inc., a licensed real estate broker that is an affiliate of Anna Gluskin, our Chairman, President and Chief Executive Officer, received a commission from the proceeds of the sale to the seller in the amount of 3% of the purchase price, or $45,714. We believe that this is less than the aggregate commission which would have been payable if a commission had been negotiated with an unaffiliated broker on an arm's length basis.

On December 9, 2005, our Board of Directors also approved a one-time recompense payment in the aggregate amount of $1,000,000 for each of Ms. Gluskin and Ms. Rose Perri, our Chief Operating Officer, Chief Financial Officer, Treasurer and Secretary, in recognition of the company’s failure to remunerate each of Ms. Gluskin and Ms. Perri in each of the fiscal years ended July 31, 1998, 1999, 2000 and 2001 in a fair and reasonable manner commensurate with comparable industry standards and Ms. Gluskin’s and Ms. Perri’s duties, responsibilities and performance during such years. The payment of such amount to each of Ms. Gluskin and Ms. Perri will be made (a) in cash at such time or times and in such amounts as determined solely by Ms. Gluskin or Ms. Perri, as applicable, and/or (b) in shares of our common stock at such time or times as determined by Ms. Gluskin or Ms. Perri, as applicable, provided that the conversion price for any such shares shall be equal to the average closing price of our common stock on the NASDAQ Capital Market for the 20 successive trading days immediately preceding, but not including, December 9, 2005. The amounts were not paid as of March 7, 2007 with the exception of $415,742.30 that was used by Ms. Perri to repay Note Receivable, Due from Related Party. The amount was due from EBI, Inc., a shareholder of the Company that is controlled by the estate of the Company’s former Chairman of the Board, Mark Perri. The note was not interest bearing, unsecured and did not have any fixed terms of repayment. The note was extended to EBI, Inc. in May 1997.
 
On December 9, 2005, our Board of Directors also approved the grant to Ms. Perri of a right of first refusal in respect of any sale, transfer, assignment or other disposition of either or both real properties municipally known as 1740 Sismet Road, Mississauga, Ontario and 98 Stafford Drive, Brampton, Ontario (collectively, the “Properties”). We granted Ms. Perri this right in recognition of the fair market value transfer to us during the fiscal year ended July 31, 1998 by Ms. Perri (or parties related to her) of the Properties.

We utilize a management company to manage all of our real properties. The property management company is owned by Ms. Perri, Ms. Gluskin and the estate of Mark Perri, our former Chairman of the Board. In the fiscal quarters ended January 31, 2006 and 2007, we paid the management company approximately $11,464 and $11,000, respectively, in management fees.

David Wires, one of our directors, is a partner of the firm Wires Jolley LLP. Wires Jolley represents us in various matters. During fiscal 2006, we paid approximately $85,000 in fees to Wires Jolley. We continue to use Wires Jolley and expect to pay legal fees in similar amounts to the firm in fiscal 2007. For the six month ended January 31, 2007 we paid approximately $63,000 in legal fees to Wires Jolley LLP.

Peter Amanatides, one of our directors, is the Senior Vice-President & Chief Operating Officer of PharmaLogika, Inc., a private consulting firm in the pharmaceuticals regulatory field.  During fiscal 2006, Generex paid $150,000 in fees to PharmaLogika for services rendered.  For the six month period ended January 31, 2007, Generex paid $100,000 in fees to PharmaLogika for services rendered and an invoice for a further $50,000 remains outstanding.  We do not expect to pay any further fees to PharmaLogika on a go-forward basis.  Mr. Amanatides is neither a director nor a shareholder of PharmaLogika.

New Accounting Pronouncements

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. We are currently evaluating the impact of adopting this statement.
 
22


In March 2006, the FASB issued SFAS No. 156, “Accounting for Servicing of Financial Assets,” to simplify accounting for separately recognized servicing assets and servicing liabilities. SFAS No. 156 amends SFAS No. 140, “Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.” Additionally, SFAS No. 156 permits, but does not require, an entity to choose either the amortization method or the fair value measurement method for measuring each class of separately recognized servicing assets and servicing liabilities. SFAS No. 156 applies to all separately recognized servicing assets and servicing liabilities acquired or issued after the beginning of an entity’s fiscal year that begins after September 15, 2006, although early adoption is permitted. We are currently evaluating the impact of adopting this statement.

In July 2006, the FASB published FASB Interpretation No. 48 (FIN No. 48), “Accounting for Uncertainty in Income Taxes”, to address the noncomparability in reporting tax assets and liabilities resulting from a lack of specific guidance in SFAS No. 109, “Accounting for Income Taxes,” on the uncertainty in income taxes recognized in an enterprise’s financial statements. FIN No. 48 will apply to fiscal years beginning after December 15, 2006, with earlier adoption permitted. We do not expect that the adoption of FIN No. 48 will have a significant impact on our consolidated results of operations or financial position.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” to eliminate the diversity in practice that exists due to the different definitions of fair value and the limited guidance for applying those definitions in GAAP that are dispersed among the many accounting pronouncements that require fair value measurements. SFAS No. 157 retains the exchange price notion in earlier definitions of fair value, but clarifies that the exchange price is the price in an orderly transaction between market participants to sell an asset or liability in the principal or most advantageous market for the asset or liability. Moreover, the SFAS states that the transaction is hypothetical at the measurement date, considered from the perspective of the market participant who holds the asset or liability. Consequently, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (an exit price), as opposed to the price that would be paid to acquire the asset or received to assume the liability at the measurement date (an entry price).

SFAS No. 157 also stipulates that, as a market-based measurement, fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability, and establishes a fair value hierarchy that distinguishes between (a) market participant assumptions developed based on market data obtained from sources independent of the reporting entity (observable inputs) and (b) the reporting entity's own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). Finally, SFAS No. 157 expands disclosures about the use of fair value to measure assets and liabilities in interim and annual periods subsequent to initial recognition. Entities are encouraged to combine the fair value information disclosed under SFAS No. 157 with the fair value information disclosed under other accounting pronouncements, including SFAS No. 107, “Disclosures about Fair Value of Financial Instruments,” where practicable. The guidance in this Statement applies for derivatives and other financial instruments measured at fair value under SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities,” at initial recognition and in all subsequent periods. SFAS No. 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years, although earlier application is encouraged. Additionally, prospective application of the provisions of SFAS No. 157 is required as of the beginning of the fiscal year in which it is initially applied, except when certain circumstances require retrospective application. We are currently evaluating the impact of adopting this statement.

In September 2006, the FASB issued “Statement of Financial Accounting Standards No. 158, Employers’ Accounting for Defined Benefit Pension and Other Postretirement Plans (an amendment of FASB Statements No. 87, 88, 106, and 132R)”, which will require employers to fully recognize the obligations associated with single-employer defined benefit pension, retiree healthcare and other postretirement plans in their financial statements. Under past accounting standards, the funded status of an employer’s postretirement benefit plan (i.e., the difference between the plan assets and obligations) was not always completely reported in the balance sheet. Past standards only required an employer to disclose the complete funded status of its plans in the notes to the financial statements. SFAS No. 158 applies to plan sponsors that are public and private companies and nongovernmental not-for-profit organizations. The requirement to recognize the funded status of a benefit plan and the disclosure requirements are effective as of the end of the fiscal year ending after December 15, 2006, for entities with publicly traded equity securities, and at the end of the fiscal year ending after June 15, 2007, for all other entities. The requirement to measure plan assets and benefit obligations as of the date of the employer’s fiscal year-end statement of financial position is effective for fiscal years ending after December 15, 2008. We are currently evaluating the impact of adopting this statement.
 
23


In February 2007, the FASB issued SFAS No. 159, “Establishing the Fair Value Option for Financial Assets and Liabilities” to permit all entities to choose to elect to measure eligible financial instruments at fair value. The decision whether to elect the fair value option may occur for each eligible item either on a specified election date or according to a preexisting policy for specified types of eligible items. However, that decision must also take place on a date on which criteria under SFAS 159 occurs. Finally, the decision to elect the fair value option shall be made on an instrument-by-instrument basis, except in certain circumstances. An entity shall report unrealized gains and losses on items for which the fair value option has been elected in earnings at each subsequent reporting date, and recognize upfront costs and fees related to those items in earnings as incurred and not deferred. SFAS No. 159 applies to fiscal years beginning after November 15, 2007, with early adoption permitted for an entity that has also elected to apply the provisions of SFAS No. 157 , Fair Value Measurements. An entity is prohibited from retrospectively applying SFAS No. 159, unless it chooses early adoption. SFAS No. 159 also applies to eligible items existing at November 15, 2007 (or early adoption date).

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, 2007, we had fixed rate debt totaling $2,871,861. This amount consists of the following:

Loan Amount
 
Interest Rate
per Annum
 
403,772
   
6.82
%
250,348
   
6.82
%
610,419
   
7.60
%
338,360
   
8.50
%
193,631
   
10
%
1,075,331
   
6.07
%
2,871,861
   
Total
 

These debt instruments mature from August 2008 through June 2011. 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.

Evaluation of disclosure controls and procedures
 
Prior to the filing of this Quarterly Report on Form 10-Q, an evaluation was performed under the supervision of and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures. Based on the evaluation our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this Quarterly Report of Form 10-Q, the Company’s disclosure controls and procedures were effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and is accumulated and communicated to the Company’s management, as appropriate, to allow timely decisions regarding required disclosures.
 
24

 
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.

PART II - OTHER INFORMATION

Item 1. Legal Proceedings.

Shemano Group, Inc . As described in our Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2006, on September 26, 2006, Shemano Group, Inc. initiated a National Association of Securities Dealers arbitration proceeding against us. Shemano claims it is entitled to be paid fees in connection with our private placements in September 2005, January 2006 and June 2006, pursuant to an Exclusive Finder’s Agreement dated November 1, 2004. Shemano claims it is entitled to fees of $945,000 in cash and warrants exercisable for 405,000 shares of our common stock. We have since filed an answer with the NASD and plan to defend this action vigorously. An arbitration hearing in this matter has been scheduled for late June 2007. We are not able to predict the ultimate outcome of this legal proceeding at the present time.

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

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

Item 1A. Risk Factors.

In addition to the other information included in this Quarterly Report on Form 10-Q, you should carefully review and consider the factors discussed in Part I, Item 1A - Risk Factors of our Annual Report on Form 10-K for the year ended July 31, 2006, certain of which have been updated below. These factors materially affect our business, financial condition or future results of operations. The risks, uncertainties and other factors described in our Annual Report on Form 10-K and below are not the only ones facing our company. Additional risks, uncertainties and other factors not presently known to us or that we currently deem immaterial may also impair our business operations, financial condition or operating results. Any of the risks, uncertainties and other factors could cause the trading price of our common stock to decline substantially.

Risks Related to Our Financial Condition

We 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. In the quarterly period ending January 31, 2007, we have received nominal revenues from sales of our confectionary, Glucose RapidSpray™, and we expect to receive some revenue from the sale of our oral insulin product in Ecuador in the third or fourth quarter of fiscal 2007. To date, we have not been profitable and our accumulated net loss was $197,348,991 at January 31, 2007. 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.
 
25


With the exception of Generex Oral-lyn™ which is currently selling in Ecuador and Glucose RapidSpray™ which we began selling in the United States and Canada in late 2006, 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.

Risks Related to Marketing of Our Potential Products

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. Initial supplies of this product, which is marketed as Exubera®, became available in the U.S. in September 2006. We understand that an expanded roll-out of Exubera® to primary-care physicians and direct-to-consumer advertising in the U.S., which Pfizer previously targeted for November 2006, is now scheduled to begin in the second half of 2007. 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.

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

Unregistered Sales of Equity Securities

As previously reported in our Quarterly Reports on Form 10-Q for the three-month periods ended April 30, 2006 and October 31, 2006, our Board of Directors on April 17, 2006 approved the issuance of an aggregate of 72,000 shares of our restricted common stock as partial consideration the provision of services by The Abajian Group, LLC (“Abajian”) under an agreement with us relating to the solicitation, evaluation and design of third-party wholesale and retail distribution channels for certain of our products. Subsequently, our Board of Directors approved the issuance of an additional 28,000 shares pursuant to this agreement and approved the modification of certain provisions of this agreement. These shares (100,000 in the aggregate) were qualified for public re-sale pursuant to the registration statement, which we filed and which was declared effective by the SEC on July 21, 2006. During the three months ended January 31, 2007 pursuant to the directions from Abajian, we issued 25,000 of such shares to Ananindeau, S.A.. We believe that the issuance of such shares is exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance upon Section 4(2) thereof.  The issuance of such securities does not involve the use of underwriters, and no commissions will be paid in connection therewith.
 
26


As previously reported in our Annual Report on Form 10-K for the fiscal year ended July 31, 2006 and our Quarterly Report for the quarter ended October 31, 2006, our Board of Directors, on September 8, 2006, approved the issuance of up to 300,000 shares our restricted common stock (in equal monthly installments of 25,000 shares) in payment of services to be rendered by CEOcast, Inc., a consultant, pursuant to an agreement to provide us with investor relation services for the period August 22, 2006 to August 21, 2007. During the three months ended January 31, 2007, we issued 75,000 shares of common stock to CEOcast, Inc. pursuant to this agreement. The sale of such shares was exempt from registration under the Securities Act in reliance upon Section 4(2) thereof. We believe that CEOcast, Inc. is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D under the Securities Act. The certificates issued for the shares of common stock will be legended to indicate that they are restricted. The sales of such securities did not involve the use of underwriters, and no commissions were paid in connection therewith.

Issuer Purchases of Equity Securities

Neither 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 January 31, 2007.

Item 3. Defaults Upon Senior Securities.

None.

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

None.

Item 5. Other Information.

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

27


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 (incorporated by reference to Exhibit 3(II) to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 19, 2006)
 
 
 
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
 
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)
 
 
 
4.3.1
 
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)
 
 
 
4.3.2
 
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)
 
 
 
4.3.3
 
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)
 
 
 
4.4.1
 
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)
 
 
 
4.4.2
 
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)
 
 
 
4.4.3
 
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)
 
28

 
Exhibit
Number
 
Description of Exhibit(1)
4.4.4
 
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)
 
 
 
4.5.1
 
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)
 
 
 
4.5.2
 
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)
 
 
 
4.5.3
 
Form of Warrant issued in connection with Exhibit 4.5.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
 
 
 
4.5.4
 
Form of Additional Investment Right issued in connection with Exhibit 4.5.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.6.1
 
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)
 
 
 
4.6.2
 
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)
 
 
 
4.6.3
 
Warrant issued in connection with Exhibit 4.6.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.6.4
 
Additional Investment Right issued in connection with Exhibit 4.6.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.7.1
 
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)
 
 
 
4.7.2
 
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)
 
 
 
4.7.3
 
Warrant issued in connection with Exhibit 4.7.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.7.4
 
Additional Investment Right issued in connection with Exhibit 4.7.1 (incorporated by reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.8.1
 
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)
 
29

 
Exhibit
Number
 
Description of Exhibit(1)
4.8.2
 
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)
 
 
 
4.8.3
 
Warrant issued in connection with Exhibit 4.8.1 (incorporated by reference to Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.8.4
 
Additional Investment Right issued in connection with Exhibit 4.8.1 (incorporated by reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.8.5
 
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)
 
 
 
4.9.1
 
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)
 
 
 
4.9.2
 
Registration Rights Agreement, dated February 11, 2004, by and between Generex Biotechnology Corporation and Michael Sourlis (incorporated by reference to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.9.3
 
Additional Investment Right issued in connection with Exhibit 4.9.1 (incorporated by reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.10.1
 
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)
 
 
 
4.10.2
 
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)
 
 
 
4.10.3
 
Warrant issued in connection with Exhibit 4.10.1 (incorporated by reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.10.4
 
Additional Investment Right issued in connection with Exhibit 4.10.1 (incorporated by reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.11.1
 
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)
 
 
 
4.11.2
 
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)
 
 
 
4.11.3
 
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 filed on July 14, 2004)
 
30

 
Exhibit
Number
 
Description of Exhibit(1)
4.11.4
 
Form of Additional Investment Right issued in connection Exhibit 4.11.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
 
 
 
4.12.1
 
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)
 
 
 
4.12.2
 
Form of 6% Secured Convertible Debenture issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
 
4.12.3
 
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)
 
 
 
4.12.4
 
Form of Additional Investment Right issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
 
4.12.5
 
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)
 
 
 
4.12.6
 
Form of Voting Agreement entered into in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
 
4.13
 
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)
 
 
 
4.14
 
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)
 
 
 
4.15.1
 
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)
 
 
 
4.15.2
 
Form of AIR Debenture issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
 
 
4.15.3
 
Form of AIR Warrant issued in connection with Exhibit 4.15.1(incorporated by reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
 
 
4.15.4
 
Form of Additional AIR issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
31

 
Exhibit
Number
 
Description of Exhibit(1)
4.16.1
 
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)
 
 
 
4.16.2
 
Form of Air Debenture issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
 
 
 
4.16.3
 
Form of AIR Warrant issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
 
 
 
4.16.4
 
Form of Additional AIR issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
 
 
 
4.17
 
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)
 
 
 
4.18.1
 
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)
 
 
 
4.18.2
 
Additional AIR Debenture issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.37 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on December 15, 2005)
 
 
 
4.18.3
 
Additional AIR Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.38 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on December 15, 2005)
 
 
 
4.19.1
 
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)
 
 
 
4.19.2
 
Form of AIR Debentures issued in connection with Exhibit 4.19.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
 
4.19.3
 
Form of AIR Warrants issued in connection with Exhibit 4.19.1 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
 
4.19.4
 
Form of Additional AIRs issued in connection with Exhibit 4.19.1 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
 
4.20
 
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)
 
 
 
4.21
 
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)
 
32

 
Exhibit
Number
 
Description of Exhibit(1)
4.22
 
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)
 
 
 
4.23
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Cranshire Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
 
 
 
4.24
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Omicron Master Trust dated February 27, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.25
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Iroquois Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.26
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Smithfield Fiduciary LLC dated February 27, 2006 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.27
 
Form of Warrant issued by Generex Biotechnology Corporation on February 27, 2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006).
     
4.28
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Cranshire Capital, L.P. dated February 28, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.29
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Omicron Master Trust dated February 28, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.30
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.31
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Smithfield Fiduciary LLC dated February 28, 2006 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.32
 
Form of Additional Air Debenture issued by Generex Biotechnology Corporation on February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006).
     
4.33
 
Form of Additional Air Warrant issued by Generex Biotechnology Corporation on February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006).
 
33

 
Exhibit
Number
 
Description of Exhibit(1)
4.34
 
Form of Agreement to Amend Warrants between Generex Biotechnology Corporation and the Investors dated March 6, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 7, 2006).
     
4.35
 
Form of Warrant issued by Generex Biotechnology Corporation on March 6, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 7, 2006)
     
4.36
 
Warrant issued by Generex Biotechnology Corporation on April 17, 2006 to Zapfe Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 14, 2006).
     
4.37
 
Form of Warrant issued by Generex Biotechnology Corporation on April 17, 2006 to certain employees (incorporated by reference to Exhibit 4.34 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 14, 2006).
     
4.38
 
Securities Purchase Agreement entered into by and between Generex Biotechnology Corporation and four Investors on June 1, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.39
 
Form of Warrant issued by Generex Biotechnology Corporation on June 1, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.40
 
Form of Amendment to Outstanding Warrants (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.41
 
Form of Warrant issued by Generex Biotechnology Corporation on June 1, 2006 in connection with Exhibit 4.37 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
9
 
Form of Voting Agreement entered into in connection with Exhibit 4.12.1 (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.

34


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
     
 
GENEREX BIOTECHNOLOGY CORPORATION
(Registrant)
 
 
 
 
 
 
Date: March 12, 2007
By:  
/s/ Anna E. Gluskin
 
Anna E. Gluskin
 
President and Chief Executive Officer
 
     
Date: March 12, 2007
By:  
/s/ Rose C. Perri
 
Rose C. Perri
 
Chief Financial Officer
 
35


Generex Biotechnology Corporation
Form 10-Q
January 31, 2007
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 (incorporated by reference to Exhibit 3(II) to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 19, 2006)
 
 
 
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
 
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)
 
 
 
4.3.1
 
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)
 
 
 
4.3.2
 
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)
 
 
 
4.3.3
 
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)
 
 
 
4.4.1
 
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)
 
 
 
4.4.2
 
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)
 
 
 
4.4.3
 
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)
 
36

 
Exhibit
Number
 
Description of Exhibit(1)
4.4.4
 
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)
 
 
 
4.5.1
 
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)
 
 
 
4.5.2
 
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)
 
 
 
4.5.3
 
Form of Warrant issued in connection with Exhibit 4.5.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
 
 
 
4.5.4
 
Form of Additional Investment Right issued in connection with Exhibit 4.5.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.6.1
 
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)
 
 
 
4.6.2
 
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)
 
 
 
4.6.3
 
Warrant issued in connection with Exhibit 4.6.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.6.4
 
Additional Investment Right issued in connection with Exhibit 4.6.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.7.1
 
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)
 
 
 
4.7.2
 
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)
 
 
 
4.7.3
 
Warrant issued in connection with Exhibit 4.7.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.7.4
 
Additional Investment Right issued in connection with Exhibit 4.7.1 (incorporated by reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.8.1
 
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)
 
37

 
Exhibit
Number
 
Description of Exhibit(1)
4.8.2
 
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)
 
 
 
4.8.3
 
Warrant issued in connection with Exhibit 4.8.1 (incorporated by reference to Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.8.4
 
Additional Investment Right issued in connection with Exhibit 4.8.1 (incorporated by reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.8.5
 
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)
 
 
 
4.9.1
 
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)
 
 
 
4.9.2
 
Registration Rights Agreement, dated February 11, 2004, by and between Generex Biotechnology Corporation and Michael Sourlis (incorporated by reference to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.9.3
 
Additional Investment Right issued in connection with Exhibit 4.9.1 (incorporated by reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.10.1
 
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)
 
 
 
4.10.2
 
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)
 
 
 
4.10.3
 
Warrant issued in connection with Exhibit 4.10.1 (incorporated by reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.10.4
 
Additional Investment Right issued in connection with Exhibit 4.10.1 (incorporated by reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
 
 
 
4.11.1
 
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)
 
 
 
4.11.2
 
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)
 
38

 
Exhibit
Number
 
Description of Exhibit(1)
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 filed on July 14, 2004)
 
 
 
4.11.4
 
Form of Additional Investment Right issued in connection Exhibit 4.11.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
 
 
 
4.12.1
 
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)
 
 
 
4.12.2
 
Form of 6% Secured Convertible Debenture issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
 
4.12.3
 
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)
 
 
 
4.12.4
 
Form of Additional Investment Right issued in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
 
4.12.5
 
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)
 
 
 
4.12.6
 
Form of Voting Agreement entered into in connection with Exhibit 4.12.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
 
 
 
4.13
 
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)
 
 
 
4.14
 
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)
 
 
 
4.15.1
 
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)
 
 
 
4.15.2
 
Form of AIR Debenture issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
 
 
4.15.3
 
Form of AIR Warrant issued in connection with Exhibit 4.15.1(incorporated by reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
 
 
4.15.4
 
Form of Additional AIR issued in connection with Exhibit 4.15.1 (incorporated by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 31, 2005)
 
39

 
Exhibit
Number
 
Description of Exhibit(1)
4.16.1
 
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)
 
 
 
4.16.2
 
Form of Air Debenture issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
 
 
 
4.16.3
 
Form of AIR Warrant issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
 
 
 
4.16.4
 
Form of Additional AIR issued in connection with Exhibit 4.16.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 9, 2005)
 
 
 
4.17
 
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)
 
 
 
4.18.1
 
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)
 
 
 
4.18.2
 
Additional AIR Debenture issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.37 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on December 15, 2005)
 
 
 
4.18.3
 
Additional AIR Warrant issued by Generex Biotechnology Corporation to Omicron Master Trust on October 27, 2005 issued in connection with Exhibit 4.18.1 (incorporated by reference to Exhibit 4.38 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on December 15, 2005)
 
 
 
4.19.1
 
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)
 
 
 
4.19.2
 
Form of AIR Debentures issued in connection with Exhibit 4.19.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
 
4.19.3
 
Form of AIR Warrants issued in connection with Exhibit 4.19.1 (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
 
4.19.4
 
Form of Additional AIRs issued in connection with Exhibit 4.19.1 (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 5, 2005)
 
 
 
4.20
 
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)
 
40

 
Exhibit
Number
 
Description of Exhibit(1)
4.21
 
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)
 
 
 
4.22
 
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)
 
 
 
4.23
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Cranshire Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
 
 
 
4.24
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Omicron Master Trust dated February 27, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.25
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Iroquois Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.26
 
Agreement to amend Warrants between Generex Biotechnology Corporation and Smithfield Fiduciary LLC dated February 27, 2006 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.27
 
Form of Warrant issued by Generex Biotechnology Corporation on February 27, 2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006).
     
4.28
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Cranshire Capital, L.P. dated February 28, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.29
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Omicron Master Trust dated February 28, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.30
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.31
 
Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Smithfield Fiduciary LLC dated February 28, 2006 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.32
 
Form of Additional Air Debenture issued by Generex Biotechnology Corporation on February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006).
     
4.33
 
Form of Additional Air Warrant issued by Generex Biotechnology Corporation on February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006).
 
41

 
Exhibit
Number
 
Description of Exhibit(1)
4.34
 
Form of Agreement to Amend Warrants between Generex Biotechnology Corporation and the Investors dated March 6, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 7, 2006).
     
4.35
 
Form of Warrant issued by Generex Biotechnology Corporation on March 6, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 7, 2006)
     
4.36
 
Warrant issued by Generex Biotechnology Corporation on April 17, 2006 to Zapfe Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 14, 2006).
     
4.37
 
Form of Warrant issued by Generex Biotechnology Corporation on April 17, 2006 to certain employees (incorporated by reference to Exhibit 4.34 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 14, 2006).
     
4.38
 
Securities Purchase Agreement entered into by and between Generex Biotechnology Corporation and four Investors on June 1, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.39
 
Form of Warrant issued by Generex Biotechnology Corporation on June 1, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.40
 
Form of Amendment to Outstanding Warrants (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.41
 
Form of Warrant issued by Generex Biotechnology Corporation on June 1, 2006 in connection with Exhibit 4.37 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
9
 
Form of Voting Agreement entered into in connection with Exhibit 4.12.1 (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.

42