GENEREX BIOTECHNOLOGY CORP - Quarter Report: 2007 April (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT OF 1934
For
the
quarterly period ended April 30, 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 ¨ Accelerated
filer x Non-accelerated
filer ¨
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 108,983,154 as of May 22, 2007.
GENEREX
BIOTECHNOLOGY CORPORATION
INDEX
PART
I. FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial
Statements.
|
|
|
|
(Unaudited)
|
|
Consolidated
Balance Sheets -
|
|
April
30, 2007 and July 31, 2006
|
1
|
|
|
Consolidated
Statements of Operations -- for the three and nine month
|
|
periods
ended April 30, 2007 and 2006, and cumulative from
|
|
November
2, 1995 to April 30, 2007
|
2
|
|
|
Consolidated
Statements of Cash Flows -- For the nine month
|
|
periods
ended April 30, 2007 and 2006, and cumulative from
|
|
November
2, 1995 to April 30, 2007
|
3
|
|
|
Notes
to Consolidated Financial Statements
|
4
|
|
|
Item
2. Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
|
|
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
|
22
|
|
|
Item
4. Controls
and Procedures
|
23
|
|
|
PART
II: OTHER INFORMATION
|
|
|
|
Item
1. Legal
Proceedings
|
23
|
Item
1A. Risk
Factors
|
23
|
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
|
24
|
|
|
Item
3. Defaults
Upon Senior Securities
|
24
|
|
|
Item
4. Submission
of Matters to a Vote of Security Holders
|
24
|
|
|
Item
5. Other
Information
|
24
|
|
|
Item
6. Exhibits
|
25
|
|
|
Signatures
|
30
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
BALANCE SHEETS
April
30,
|
|
July
31
|
|
|||||||
|
|
|
|
2007
|
|
2006
|
|
|||
|
|
|
|
(Unaudited)
|
|
|||||
ASSETS
|
||||||||||
Current
Assets:
|
||||||||||
Cash
and cash equivalents
|
$
|
25,813,492
|
$
|
38,208,493
|
||||||
Short-term
investments
|
14,347,782
|
14,372,653
|
||||||||
Accounts
receivable
|
85,705
|
—
|
||||||||
Inventory
|
47,885
|
—
|
||||||||
Other
current assets
|
374,390
|
237,752
|
||||||||
Total
Current Assets
|
40,669,254
|
52,818,898
|
||||||||
Property
and Equipment, Net
|
2,212,145
|
2,585,744
|
||||||||
Assets
Held for Investment, Net
|
3,559,744
|
3,602,773
|
||||||||
Patents,
Net
|
4,939,316
|
5,097,827
|
||||||||
TOTAL
ASSETS
|
$
|
51,380,459
|
$
|
64,105,242
|
||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||||
Current
Liabilities:
|
||||||||||
Accounts
payable and accrued expenses
|
$
|
6,663,668
|
$
|
5,444,790
|
||||||
Deferred
revenue
|
27,141
|
—
|
||||||||
Current
maturities of long-term debt
|
79,367
|
428,059
|
||||||||
Convertible
Debentures, Net of Debt Discount of $-0- and $608,737
|
||||||||||
at
April 30, 2007 and July 31, 2006, respectively
|
24,369
|
160,494
|
||||||||
Total
Current Liabilities
|
6,794,545
|
6,033,343
|
||||||||
Long-Term
Debt, Net
|
2,943,944
|
2,608,105
|
||||||||
Commitments
and Contingencies
|
||||||||||
Stockholders’
Equity:
|
||||||||||
Special
Voting Rights Preferred Stock, $.001 par value;
|
||||||||||
authorized
1,000 shares at April 30, 2007 and July 31, 2006; -0- and 1,000
shares
issued and outstanding at April 30, 2007 and July 31, 2006,
respectively
|
—
|
1
|
||||||||
Common
stock, $.001 par value; authorized 500,000,000 shares at
April 30, 2007
and July 31, 2006; 108,941,789 and 107,398,360 shares issued
and
outstanding, respectively
|
108,941
|
107,397
|
||||||||
Additional
paid-in capital
|
245,834,758
|
243,097,627
|
||||||||
Deficit
accumulated during the development stage
|
(205,067,346
|
)
|
(188,495,312
|
)
|
||||||
Accumulated
other comprehensive income
|
765,617
|
754,081
|
||||||||
Total
Stockholders’ Equity
|
41,641,970
|
55,463,794
|
||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
51,380,459
|
$
|
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 Ended
|
|
For
the Nine Months Ended
|
|
(Date
of Inception)
|
|
|||||||||
|
|
April
30,
|
|
April
30,
|
April
30,
|
|||||||||||
2007
|
|
2006
|
|
2007
|
|
2006
|
2007
|
|||||||||
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
||||||||
Revenues
|
$
|
11,939
|
$
|
43,750
|
$
|
196,867
|
$
|
131,250
|
$
|
2,391,163
|
||||||
Sales
discounts
|
(979
|
)
|
—
|
(1,481
|
)
|
—
|
(1,481
|
)
|
||||||||
Net
Revenue
|
10,960
|
43,750
|
195,386
|
131,250
|
2,389,682
|
|||||||||||
Cost
of Goods Sold
|
16,039
|
—
|
69,020
|
—
|
69,020
|
|||||||||||
Operating
Expenses:
|
||||||||||||||||
Research
and development
|
4,177,070
|
1,635,238
|
8,373,393
|
3,939,432
|
69,846,231
|
|||||||||||
Research
and development -
|
||||||||||||||||
related
party
|
—
|
—
|
—
|
—
|
220,218
|
|||||||||||
Selling
and marketing
|
73,503
|
—
|
214,089
|
13,000
|
270,117
|
|||||||||||
General
and administrative
|
3,750,420
|
2,299,011
|
9,003,615
|
7,361,054
|
86,725,291
|
|||||||||||
General
and administrative -
|
||||||||||||||||
related
party
|
—
|
—
|
—
|
—
|
314,328
|
|||||||||||
Total
Operating Expenses
|
8,000,993
|
3,934,249
|
17,591,097
|
11,313,486
|
157,376,185
|
|||||||||||
Operating
Loss
|
(8,006,072
|
)
|
(3,890,499
|
)
|
(17,464,731
|
)
|
(11,182,236
|
)
|
(155,055,523
|
)
|
||||||
Other
Income (Expense):
|
||||||||||||||||
Miscellaneous
income (expense)
|
—
|
—
|
—
|
500
|
196,193
|
|||||||||||
Income
from Rental Operations, net
|
33,262
|
42,506
|
120,197
|
78,346
|
439,560
|
|||||||||||
Interest
income
|
514,272
|
241,053
|
1,719,169
|
257,149
|
5,881,247
|
|||||||||||
Interest
expense
|
(203,480
|
)
|
(17,227,595
|
)
|
(709,507
|
)
|
(32,458,126
|
)
|
(43,137,883
|
)
|
||||||
Loss
on extinguishment of debt
|
(56,337
|
)
|
(10,938,959
|
)
|
(237,162
|
)
|
(11,872,942
|
)
|
(14,134,068
|
)
|
||||||
Net
Loss Before Undernoted
|
(7,718,355
|
)
|
(31,773,494
|
)
|
(16,572,034
|
)
|
(55,177,309
|
)
|
(205,810,474
|
)
|
||||||
Minority
Interest Share of Loss
|
—
|
—
|
—
|
—
|
3,038,185
|
|||||||||||
Net
Loss
|
(7,718,355
|
)
|
(31,773,494
|
)
|
(16,572,034
|
)
|
(55,177,309
|
)
|
(202,772,289
|
)
|
||||||
Preferred
Stock Dividend
|
—
|
—
|
—
|
—
|
2,295,057
|
|||||||||||
Net
Loss Available to Common
|
||||||||||||||||
Shareholders
|
$
|
(7,718,355
|
)
|
$
|
(31,773,494
|
)
|
$
|
(16,572,034
|
)
|
$
|
(55,177,309
|
)
|
$
|
(205,067,346
|
)
|
|
Basic
and Diluted Net Loss Per
|
||||||||||||||||
Common
Share
|
$
|
(.07
|
)
|
$
|
(.36
|
)
|
$
|
(.15
|
)
|
$
|
(.84
|
)
|
||||
Weighted
Average Number of Shares
|
||||||||||||||||
of
Common Stock Outstanding
|
108,623,690
|
88,683,352
|
108,125,504
|
65,719,702
|
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 Nine Months Ended
|
|
(Date
of Inception)
|
|
|||||
|
|
April
30,
|
|
to
April 30,
|
|
|||||
|
|
2007
|
|
2006
|
|
2007
|
|
|||
|
|
(Unaudited)
|
|
(Unaudited)
|
|
(Unaudited)
|
||||
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
$
|
(16,572,034
|
)
|
$
|
(55,177,309
|
)
|
$
|
(202,772,289
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
||||||||||
in
operating activities:
|
||||||||||
Depreciation
and amortization
|
866,505
|
846,239
|
5,582,361
|
|||||||
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
|
237,163
|
11,872,942
|
14,134,069
|
|||||||
Common
stock issued as employee compensation
|
722,826
|
126,104
|
2,268,330
|
|||||||
Common
stock issued for services rendered
|
741,255
|
422,599
|
6,042,558
|
|||||||
Amortization
of prepaid services in conjunction with common
|
||||||||||
stock
issuance
|
—
|
138,375
|
138,375
|
|||||||
Non-cash
compensation expense
|
—
|
—
|
45,390
|
|||||||
Stock
options and warrants issued for services rendered
|
125,000
|
137,200
|
7,131,323
|
|||||||
Issuance
of warrants as additional exercise right inducement
|
—
|
16,888,239
|
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
|
—
|
1,195,315
|
1,482,879
|
|||||||
Amortization
of discount on convertible debentures
|
608,737
|
14,075,693
|
18,930,427
|
|||||||
Common
stock issued as interest payment on convertible
|
||||||||||
debentures
|
15,716
|
168,365
|
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
|
—
|
7,882
|
113,274
|
|||||||
Changes
in operating assets and liabilities (excluding the
|
||||||||||
effects
of acquisition):
|
||||||||||
Accounts
receivable
|
(84,504
|
)
|
—
|
(84,504
|
)
|
|||||
Miscellaneous
receivables
|
—
|
—
|
43,812
|
|||||||
Inventory
|
(46,711
|
)
|
—
|
(46,711
|
)
|
|||||
Other
current assets
|
15,485
|
45,275
|
(87,160
|
)
|
||||||
Accounts
payable and accrued expenses
|
1,209,487
|
1,182,117
|
10,855,406
|
|||||||
Deferred
revenue
|
27,141
|
—
|
27,141
|
|||||||
Other,
net
|
—
|
—
|
110,317
|
|||||||
Net
Cash Used in Operating Activities
|
(12,130,837
|
)
|
(8,056,162
|
)
|
(112,788,049
|
)
|
||||
Cash
Flows From Investing Activities:
|
||||||||||
Purchase
of property and equipment
|
(77,208
|
)
|
(85,168
|
)
|
(4,519,915
|
)
|
||||
Costs
incurred for patents
|
(149,243
|
)
|
(37,253
|
)
|
(1,758,239
|
)
|
||||
Change
in restricted cash
|
—
|
214,364
|
45,872
|
|||||||
Proceeds
from maturity of short term investments
|
22,285,763
|
3,000,000
|
157,572,809
|
|||||||
Purchases
of short-term investments
|
(22,260,892
|
)
|
(13,773,605
|
)
|
(171,920,591
|
)
|
||||
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
|
(150,082
|
)
|
—
|
(656,915
|
)
|
|||||
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
|
(351,662
|
)
|
(10,681,662
|
)
|
(24,536,714
|
)
|
||||
Cash
Flows From Financing Activities:
|
||||||||||
Proceeds
from short-term advance
|
—
|
—
|
325,179
|
|||||||
Repayment
of short-term advance
|
—
|
(347,369
|
)
|
(347,369
|
)
|
|||||
Proceeds
from issuance of long-term debt
|
—
|
35,051
|
2,005,609
|
|||||||
Repayment
of long-term debt
|
(53,079
|
)
|
(297,792
|
)
|
(1,832,297
|
)
|
||||
Change
in due to related parties
|
—
|
—
|
154,541
|
|||||||
Proceeds
from exercise of warrants
|
125,000
|
32,819,119
|
44,015,049
|
|||||||
Proceeds
from exercise of stock options
|
176,983
|
3,174,555
|
4,429,178
|
|||||||
Proceeds
from minority interest investment
|
—
|
—
|
3,038,185
|
|||||||
Proceeds
from issuance of preferred stock
|
—
|
—
|
12,015,000
|
|||||||
Redemption
of SVR preferred stock
|
(100
|
)
|
—
|
(100
|
)
|
|||||
Proceeds
from issuance of convertible debentures, net
|
—
|
13,955,000
|
20,254,930
|
|||||||
Repayments
of convertible debentures
|
(150,030
|
)
|
—
|
(611,388
|
)
|
|||||
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
|
98,774
|
49,338,564
|
163,127,301
|
|||||||
Effect
of Exchange Rates on Cash
|
(11,276
|
)
|
(4,084
|
)
|
10,954
|
|||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(12,395,001
|
)
|
30,596,656
|
25,813,492
|
||||||
Cash
and Cash Equivalents, Beginning of Period
|
38,208,493
|
586,530
|
—
|
|||||||
Cash
and Cash Equivalents, End of Period
|
$
|
25,813,492
|
$
|
31,183,186
|
$
|
25,813,492
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
3
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. |
Basis
of Presentation
|
The
accompanying unaudited interim consolidated financial statements have been
prepared pursuant to the rules and regulations for reporting on Form 10-Q.
Accordingly, certain information and disclosures required by generally accepted
accounting principles for complete financial statements are not included
herein.
The interim statements should be read in conjunction with the financial
statements and notes thereto included in the Company’s latest Annual Report on
Form 10-K. The results for the three and nine 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 a commercial product, Glucose RapidSprayTM,
which
has generated revenue commencing during the nine months ended April 30, 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 zero at April
30,
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.
4
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.
Reclassifications
Certain
prior period balances have been reclassified in order to conform to the current
period presentation. Such reclassifications have no effect on prior periods
net
loss.
3. |
Effects
of Recent Accounting
Pronouncements
|
In
September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements" ("SFAS
157"). SFAS 157 defines fair value, establishes a framework for measuring
fair
value in accordance with accounting principles generally accepted in the
United
States, and expands disclosures about fair value measurements. SFAS No. 157
is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, with earlier application encouraged. Any amounts recognized
upon adoption as a cumulative effect adjustment will be recorded to the opening
balance of retained earnings in the year of adoption. The Company is currently
evaluating the impact of this statement on its results of operations or
financial position of the Company.
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 and certain other items at fair
value. The decision whether to elect the fair value option may occur for
each eligible items 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. 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. The
Company is currently evaluating this pronouncement in connection with SFAS
No.
157.
5
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
4. |
Stock-Based
Compensation
|
As
of
April 30, 2007, the Company had three stockholder-approved stock incentive
plans
under which shares and options exercisable for shares of common stock have
been
or may be granted to employees, directors, consultants and advisors. A total
of
2,000,000 shares of common stock are reserved for issuance under the 2000
Stock
Option Plan (the 2000 Plan), a total of 12,000,000 shares of common stock
are
reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan) and
10,000,000 shares of common stock are reserved for issuance under the 2006
Stock
Plan (the 2006 Plan). Restricted shares can only be issued under 2006 Plan.
There were 1,900,000, 1,047,490 and 8,958,000 shares of common stock reserved
for future awards under the 2000 Plan, 2001 Plan and 2006 Plan, respectively,
as
of April 30, 2007.
The
2000,
2001 and 2006 Plans (the Plans) are administered by the Board of Directors
(the
Board). The Board is authorized to select from among eligible employees,
directors, advisors and consultants those individuals to whom options are
to be
granted and to determine the number of shares to be subject to, and the terms
and conditions of the options. The Board is also authorized to prescribe,
amend
and rescind terms relating to options granted under the Plans. Generally,
the
interpretation and construction of any provision of the Plans or any options
granted hereunder is within the discretion of the Board.
The
Plans
provide that options may or may not be Incentive Stock Options (ISOs) within
the
meaning of Section 422 of the Internal Revenue Code. Only employees of the
Company are eligible to receive ISOs, while employees and non-employee
directors, advisors and consultants are eligible to receive options which
are
not ISOs, i.e. “Non-Qualified Options.” The options granted by the Board in
connection with its adoption of the Plans are Non-Qualified Options. In
addition, the 2006 Plan also provides for restricted stock grants.
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. In case of restricted stock grants under
the
2006 Plan, fair market value of the shares is the market price.
No
options were granted to employees during the nine months ended April 30,
2007. A
total of 287,000 shares of restricted common stock were granted to employees,
consultants and advisors during the nine month ended April 30, 2007 fair
valued
at $490,770 and has been included in the statement of operations (see Note
11).
6
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
summary of the stock option activity for the nine months ended April 30,
2007 is
as follows:
Weighted
|
Weighted
|
||||||||||||
Average
|
Average
|
||||||||||||
Exercise
|
Remaining
|
Aggregate
|
|||||||||||
Price
|
Contractual
|
Intrinsic
|
|||||||||||
Shares
|
Share
|
Term
(Years)
|
Value
|
||||||||||
Outstanding,
August 1, 2006
|
8,429,597
|
$
|
1.15
|
||||||||||
Granted
|
––
|
$
|
––
|
||||||||||
Forfeited
or expired
|
(185,159
|
)
|
$
|
8.08
|
|||||||||
Exercised
|
(111,800
|
)
|
$
|
1.58
|
|||||||||
Outstanding,
April 30, 2007
|
8,132,638
|
$
|
0.99
|
2.31
|
$
|
6,223,819
|
|||||||
Exercisable,
April 30, 2007
|
8,132,638
|
$
|
0.99
|
2.31
|
$
|
6,223,819
|
Grant
Date Fair Value of Cancelled Options
|
$
|
5.85
|
||
Total
Intrinsic Value of Options Exercised
|
$
|
64,329
|
The
Company had no non-vested stock options outstanding as of April 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 April 30, 2007 and
2006,
was $7,607,610 and $31,708,769, respectively, and for the nine months ended
April 30, 2007 and 2006, was $16,560,498 and $54,964,595,
respectively.
6. |
Accounts
Payable and Accrued
Expenses
|
Accounts
payable and accrued expenses consist of the following:
April
30,
|
July
31,
|
||||||
2007
|
2006
|
||||||
Accounts
Payable
|
$
|
3,148,364
|
$
|
1,214,694
|
|||
Research
and Development
|
433,939
|
696,769
|
|||||
Executive
Compensation
|
1,669,427
|
2,121,389
|
|||||
Financial
Services
|
1,411,938
|
1,411,938
|
|||||
$
|
6,663,668
|
$
|
5,444,790
|
7
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 Investors
|
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
|
$
|
4,000,000
|
||
Principal
and Interest Converted
|
$
|
3,081,556
|
||
Loss
on Extinguishment (C)
|
$
|
2,450,301
|
||
Shares
Issued Upon Conversion
|
2,448,764
|
|||
|
||||
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
|
|||
$
|
150,030
|
As
of
April 30, 2007, the $24,369 net outstanding balance of convertible debentures
is
comprised of $24,369 of debt net of unamortized debt discount of $-0- 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 Interest
Rate |
Expected Volatility |
Life
(Years)
|
|||||
4.49%
|
0.9380
|
5.50
|
8
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.
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
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
9. |
Net
Loss Per Share
|
Basic
EPS
and Diluted EPS for the three and nine months ended April 30, 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 23,513,115 and 25,246,229
incremental shares at April 30, 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 Nine Months Ended April 30,
|
|||||||
2007
|
2006
|
||||||
Cash
paid during the period for:
|
|||||||
Interest
|
$
|
196,368
|
$
|
49,864
|
|||
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
|
$
|
––
|
$
|
13,087,156
|
|||
Satisfaction
of accounts payable through the issuance of common
stock
|
$
|
––
|
$
|
391,147
|
|||
Principal
repayment of convertible debentures through the issuance of
common
stock
|
$
|
384,616
|
$
|
1,498,843
|
|||
Issuance
of common stock in conjunction with convertible debenture
conversion
|
$
|
210,216
|
$
|
14,551,466
|
|||
Increase
in other current assets for the prepayment of services through
the
issuance of common stock
|
$
|
––
|
$
|
184,500
|
|||
Satisfaction
of due from related party through reduction
of accrued executive compensation
|
$
|
––
|
$
|
415,828
|
10
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
11. |
Stockholders’
Equity
|
During
the nine months ended April 30, 2007, the Company issued an aggregate of
320,266
shares of common stock as monthly principal and interest payments totaling
$560,557 and 168,172 shares of common stock upon the conversion of $230,817
in
principal of convertible debentures (see Note 7).
During
the nine months ended April 30, 2007, the Company issued 427,264 shares of
common stock to various consultants for services rendered in the amount of
$741,255. 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 nine months ended April 30, 2007, the Company issued 128,927 shares of
common stock valued at $232,056 as employee compensation based on the quoted
market price of the Company’s common stock on the dates of the
issuances.
During
the nine months ended April 30, 2007, the Company issued 287,000 shares of
restricted common stock valued at $490,770 under the 2006 Plan (see Note
4).
During
the nine months ended April 30, 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 nine months ended April 30, 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.
During
the nine months ended April 30, 2007, the Company issued an aggregate of
100,000
warrants to consultants for services. All warrants have a five year term,
an
exercise price of $1.71 per share and were valued at $1.25. The warrants,
which
were valued using the Black-Scholes pricing model with expected volatility
of
85.81 percent and risk free interest of 8.25 percent, resulted in charges
to
operations of $125,000.
During
the nine months ended April 30, 2007, the Company redeemed and cancelled
1,000
shares of Special Voting Rights Preferred Stock for $100. This redemption
represented all issued and outstanding shares.
The
issuances of common stock as described above are summarized as
follow:
Common
Stock
|
Additional
Paid-In
|
Total
Stockholders’
|
|||||||||||
Shares
|
Amount
|
Capital
|
Equity
|
||||||||||
Convertible
Debenture Monthly
|
|||||||||||||
Repayments
|
320,266
|
$
|
320
|
$
|
560,237
|
$
|
560,557
|
||||||
Convertible
Debenture Conversions
|
168,172
|
168
|
286,986
|
287,154
|
|||||||||
Warrants
and Stock Options Exercised
for
Cash
|
211,800
|
212
|
301,770
|
301,982
|
|||||||||
Issuance
for Services
|
427,264
|
427
|
740,828
|
741,255
|
|||||||||
Issuance
as Employee Compensation
|
415,927
|
416
|
722,410
|
722,826
|
|||||||||
Total
|
1,543,429
|
$
|
1,543
|
$
|
2,612,231
|
$
|
2,613,774
|
11
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
12. |
Subsequent
Events
|
On
May
29, 2007, the Company issued a total of 450,000 shares of common stock and
140,000 warrants to purchase the common stock to consultants for services.
The
shares were valued at $1.45 per share based on the quoted market price of
the
Company’s common stock on the date of the issue. All warrants have a five year
term, an exercise price of $1.45 per share and were valued at $1.01. The
warrants, which were valued using the Black-Scholes pricing model with expected
volatility of 84.45 percent and risk free interest of 5.27 percent, resulted
in
charges to operations of $141,400.
12
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 nine-month
periods ended April 30, 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 April 30,
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 April 30, 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:
|
Ÿ
|
our
expectations concerning product candidates for our
technologies;
|
|
Ÿ
|
our
expectations concerning existing or potential development and license
agreements for third-party collaborations and joint
ventures;
|
|
Ÿ
|
our
expectations of when different phases of clinical activity may commence
and conclude;
|
|
Ÿ
|
our
expectations of when regulatory submissions may be filed or when
regulatory approvals may be received; and
|
|
Ÿ
|
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:
|
Ÿ
|
the
inherent uncertainties of product development based on our new and
as yet
not fully proven technologies;
|
|
Ÿ
|
the
risks and uncertainties regarding the actual effect on humans of
seemingly
safe and efficacious formulations and treatments when tested
clinically;
|
|
Ÿ
|
the
inherent uncertainties associated with clinical trials of product
candidates;
|
|
Ÿ
|
the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product candidates;
|
|
Ÿ
|
the
inherent uncertainties associated with commercialization of products
that
have received regulatory approval; and
|
|
Ÿ
|
our
ability to obtain the necessary financing to fund our
operations.
|
Additional
factors that could affect future results are set forth 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.
13
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, did not receive any revenues from operations other than the $1,000,000
upfront payment that we received from Eli Lilly and Company pursuant to a
development and license agreement we entered into in September 2000 and
subsequently terminated as of June 2003. In the nine-month period ended April
30, 2007, we realized revenue of approximately $122,469 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. In the
United States, the product will eventually be available in over 2,500 stores,
including Aurora Pharmacy, Bi-Mart Corporation, The Diabetes Place, Fruth
Pharmacy, Inc., Hy-Vee, Inc., Kerr Drug, Inc., The Medicine Shoppe® Pharmacy,
Meijer, Inc., and ShopKo Stores. Glucose RapidSpray™ is also available on
online.
We
have
begun the regulatory approval process for six 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), the Antigen prostate cancer vaccine (Phase I),
and
the Antigen RNAi immunotherapeutic technology for myelogenous leukemia
(pre-clinical). 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
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 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, and we expect to receive revenues in calendar year 2007 from
commercial sales of our oral insulin product in Ecuador. This revenue will
not
be sufficient for all of our cash needs during fiscal 2007. In the past, we
were
able to fund Antigen expenses with some revenue from research grants for
Antigen's immunomedicine products. During the first nine months of fiscal 2007,
we received a total of $72,917 in such research grants. We do not expect to
receive such grants on a going forward basis.
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 may seek to meet all or
some
of our operating cash flow requirements through financing activities, such
as
private placement of our common stock, preferred stock offerings and offerings
of debt and convertible debt instruments. 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 actively pursuing industry
collaboration activities, including product licensing and specific project
financing.
14
We
are
pursuing regulatory approval and commercialization of our flagship product,
Generex Oral-lyn™, in a number of venues. 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 the second half of calendar year 2007. Currently, our
relationship with PharmaBrand is governed by a Letter of Intent, and we are
in
the process of negotiating a final licensing and distribution agreement with
PharmaBrand. PharmaBrand has generated some commercial sales of Generex
Oral-lyn™ in Ecuador to date. We expect to receive revenues from such sales
sometime in calendar year 2007, but we do not expect that such sales will be
reflected in our financial statements until we have entered into a definitive
licensing and distribution agreement with PharmaBrand. In addition, we expect
that we may be able to commence patient dosing in late-stage clinical trials
in
Canada in the fall of 2007 based on our Clinical Trial Application which Health
Canada approved in September 2006. In anticipation of undertaking such trials,
we have secured a manufacturer to produce clinical trial batches of Generex
Oral-lyn™. We also recently entered into a licensing and distribution agreement
with a multinational distributor to initiate the regulatory approval and
commercialization process for Generex Oral-lyn™ and Glucose RapidSpray™ in 15
Middle Eastern countries. Under the terms of this agreement, we will not receive
an upfront licensing fee, but the distributor will bear all the costs associated
with procuring governmental approvals, including any clinical or regulatory
costs.
We
face
competition from other providers of alternate forms of insulin, including Pfizer
which has an inhalable form of insulin, marketed as Exubera®. Since May 2006,
Pfizer has launched Exubera® in Germany, Ireland, the U.K. and the U.S. We
understand that an expanded roll-out of Exubera® to primary-care physicians and
direct-to-consumer advertising in the U.S., is scheduled to begin in the second
half of calendar year 2007. We believe that our buccal delivery technology
offers several advantages over alternate forms of insulin.
We
continue clinical development of Antigen’s synthetic peptide vaccines designed
to stimulate a potent and specific immune response against tumors expressing
the
HER-2/neu oncogene for patients with stage II HER-2/neu positive breast cancer
and patients with prostate cancer and against avian influenza. In May 2007,
the
first breast cancer patients received treatment in the Phase II clinical trial
of the Antigen peptide vaccine. This trial is being conducted with the United
States Military Cancer Institute Clinical Trials Group under the direction
of
Colonel George Peoples, M.D. The trial will measure the rate of relapse after
two years 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.
Euroclinic, a private center in Athens, Greece, is expected to commence clinical
trials with the same compound as an immunotherapeutic vaccine for prostate
cancer in fiscal 2007. The Lebanese-Canadian Hospital in Beirut, Lebanon
commenced a Phase I clinical trial of the Antigen synthetic avian influenza
vaccine in April 2007.
In
addition, Antigen recently entered into an agreement with Beijing Daopei
Hospital in Beijing, China to conduct clinical trials using Antigen’s novel
immunotherapeutic strategy involving RNA interference to modify a patient’s
cancer cells to increase their immunogenicity to enable the immune system to
fight cancer anywhere in the patient’s body.
We
also
expect to 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.
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 nine months, we expended resources on the clinical testing and
commercialization, of our buccal insulin product, Generex Oral-lyn™. As
described above, Health Canada approved our Clinical Trial Application for
the
commencement of late-stage trials for Generex Oral-lyn™. We have begun
preliminary preparations for initiating such trials of this product and expect
that such tests will involve tests with a large number of patients over a
significant period of time. The completion of late-stage trials in Canada and
elsewhere may require significantly greater funds than we currently have on
hand.
15
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 nine months ended April 30, 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 that we will receive revenue
from
sales of Generex Oral-lyn™ in Ecuador in calendar year 2007, we do not expect
that such revenues will be sufficient to sustain our research and development
and regulatory activities in Latin America.
During
the nine months ended April 30, 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, and clinical trials
with the same compound as an immunotherapeutic vaccine for prostate cancer
are
expected to commence in Greece during last quarter of fiscal 2007. In addition,
we began clinical trials of a synthetic immunotherapeutic vaccine for avian
influenza in Lebanon.
Although
we initiated regulatory approval process for our morphine buccal product, we
did
not expend resources to further this product during the nine-month period ended
April 30, 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
nine
months ended April 30, 2007, approximately 72% of our $8,373,393 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 nine months ended April 30, 2006, approximately 81% of our $3,939,432
in research expenses was attributable to insulin and platform technology
development, and we did not spend any money on morphine and fentanyl projects.
.
Approximately
28% or $2,390,502 of our research and development expenses for the nine months
ended April 30, 2007 was related to Antigen's immunomedicine products compared
to approximately 19% or $736,972 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 April 30, 2007 Compared to Three Months Ended April 30,
2006
Our
net
loss for the quarter ended April 30, 2007 was $7,718,355 versus $31,773,494
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 $8,006,072
compared to $3,890,499 in the third fiscal quarter of 2006. The increase
resulted from an increase in research and development expenses (to $4,177,070
from $1,635,238), an increase in general and administrative expenses (to
$3,750,420 from $2,299,011) and an increase in selling and marketing expenses
(to $73,503 from $0). Our net revenues decreased from $43,750 in the quarter
ended April 30, 2006 to $10,960 in the quarter ended April 30,
2007.
16
The
increase in research and development expenses for the quarter ended April 30,
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 is due primarily to the increase in cash and non cash
compensation to financial and other consultants, increase in legal and
accounting expenses as well as increased in travel and advertising expenses.
The
increase was partially offset by the decrease in bonus compensation paid to
executive officers.
Our
interest expense in the fiscal quarter ended April 30, 2007 decreased to
$203,480 compared to interest expense of $17,227,595 in the fiscal quarter
ended
April 30, 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 $56,337 in the
fiscal quarter ended April 30, 2007 compared to $10,938,959 in the same quarter
for the last fiscal year. Our interest income increased to $514,272 in the
fiscal quarter ended April 30, 2007 compared to $241,053 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
lower income from rental operations (net of expense) of $33,262 in the fiscal
quarter ended April 30, 2007 compared to $42,506 in the same quarter for the
last fiscal year.
Results
of Operations
Nine
Months Ended April 30, 2007 Compared to Nine Months Ended April 30,
2006
Our
net
loss for the nine months ended April 30, 2007 was $16,572,034 versus $55,177,309
in the corresponding nine-month period of the prior fiscal year. The decrease
in
net loss in this nine-month period versus the corresponding nine-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
nine months ended April 30, 2007 increased to $17,464,731 compared to
$11,182,236 in the corresponding nine-month period ended April 30, 2006. The
increase resulted from an increase in research and development expenses (to
$8,373,393 from $3,939,432), increases in general and administrative expenses
(to $9,003,615 from $7,361,054) and selling expenses (to $214,089 from $13,000).
Our net revenues increased to $195,386 in the nine months ended April 30, 2007
from $131,250 in the nine months ended April 30, 2006. The increase in net
revenues is attributable to sale of Glucose RapidSpray™.
The
increase in research and development expenses for the nine-month period ended
April 30, 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 non-recurring cash and non cash bonuses paid to executive officers
last
year. The selling expenses are associated with the commencement of the
commercial sales of Glucose RapidSpray™ that began in fiscal 2007 and were
absent last year.
Our
interest expense in the nine-month period ended April 30, 2007 decreased to
$709,507 compared to interest expense of $32,458,126 in the nine-month period
ended April 30, 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 $237,162
in the nine-month period ended April 30, 2007 compared to $11,872,942 in the
corresponding period in the last fiscal year. Our interest income increased
to
$1,719,169 in the nine-month period ended April 30, 2007 compared to $257,149
in
the same period in the last fiscal year primarily due to substantially higher
cash and short term investment balances during the current nine-month period.
We
received a slightly higher income from rental operations (net of expense) of
$120,197 in the nine months ended April 30, 2007 compared to $78,346 in the
nine
months ended April 30, 2006.
Developments
In
March
2007, our subsidiary Antigen entered into an agreement with Beijing Daopei
Hospital in Beijing, China to conduct clinical trials using Antigen’s pioneering
technology for RNA interference (RNAi) stimulation of the immune response
against patients’ immune cells. The strategy developed by Antigen involves
modifying the patient's cancer cells to increase their immunogenicity and
thereby enable the immune system to fight off the cancer anywhere in the
patient's body. Antigen has developed proprietary methods using RNAi to
specifically inhibit expression of the Ii protein in cancer cells already
expressing MHC class II molecules that are amenable to clinical use. Cancer
cells from patients with acute myelogenous leukemia will be transfected with
a
vector expressing RNAi to silence Ii expression. After lethal irradiation,
the
cells are re-introduced as a subcutaneous immunization to the
patient.
17
In
April
2007, we entered into a licensing and distribution agreement with Leosons
General Trading Company, a leading distributor of North American pharmaceutical
and healthcare products in the Middle East, for the commercialization of Generex
Oral-lyn™ in 15 Middle Eastern countries, including Saudi Arabia and the United
Arab Emirates. Under this agreement, we will not receive an upfront license
fee,
but Leosons will bear all costs associated with the procurement of governmental
approvals for the sale of the product, including any clinical and regulator
costs. Leosons is obligated to file all requisite applications for such
approvals by the fall of 2007.
In
April
2007, we also entered into a licensing and distribution agreement with Leosons
for the distribution of Glucose RapidSpray™ in the same 15 Middle Eastern
countries.
In
April
2007, the Lebanese-Canadian Hospital in Beirut, Lebanon commenced a Phase I
clinical trial of the Antigen synthetic avian influenza vaccine.
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
April
30, 2007, we had cash and short-term investments of approximately $40.2 million,
a decrease of $12.4 million from the balance as of the end of the prior fiscal
year. As of April 30, 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
April
30, 2007, we had 6% secured convertible debentures outstanding in the aggregate
principal amount of $24,369, 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.
18
Since
November 2004, we have issued an aggregate of 20,580,978 shares of common stock
resulting from the conversion and repayment of an aggregate of $17,613,894
of
debenture principal and accrued interest issued under the auspices of the
Securities Purchase Agreement dated November 10, 2004 and amendments thereto.
As
of
April 30, 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 12,199,087 shares of our common stock at varying
exercise prices for aggregate proceeds to us of $32,013,852.
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
April
30, 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
23, 2006
|
622,226
|
$
|
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
|
172,120
|
$
|
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 of 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.
19
Impairment
of Long-Lived Assets
.
Management reviews for impairment whenever events or changes in circumstances
indicate that the carrying amount of property and equipment may not be
recoverable under the provisions of Statement of Financial Accounting Standards
No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets."
If it
is determined that an impairment loss has occurred based upon expected future
cash flows, the loss is recognized in the Statement of Operations.
Intangible
Assets
. We
have intangible assets related to patents. The determination of the related
estimated useful lives and whether or not these assets are impaired involves
significant judgments. In assessing the recoverability of these intangible
assets, we use an estimate of undiscounted operating income and related cash
flows over the remaining useful life, market conditions and other factors to
determine the recoverability of the asset. If these estimates or their related
assumptions change in the future, we may be required to record impairment
charges against these assets.
Estimating
accrued liabilities, specifically litigation accruals
.
Management's current estimated range of liabilities related to pending
litigation is based on management's best estimate of future costs. While the
final resolution of the litigation could result in amounts different than
current accruals, and therefore have an impact on our consolidated financial
results in a future reporting period, management believes the ultimate outcome
will not have a significant effect on our consolidated results of operations,
financial position or cash flows.
Off-Balance
Sheet Arrangements
We
have
no off-balance sheet arrangements that have or are reasonably likely to have
a
current or future effect on the Company’s financial condition, changes in
financial condition, revenue or expenses, results of operations, liquidity,
capital expenditures or capital resources that is material to investors, and
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
|
3,047,680
|
246,265
|
1,830,076
|
971,338
|
0
|
|||||||||||
Capital
Lease Obligations
|
0
|
0
|
0
|
0
|
0
|
|||||||||||
Operating
Lease Obligations
|
122,832
|
35,050
|
81,645
|
6,137
|
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
|
$
|
3,170,512
|
$
|
281,315
|
$
|
1,911,721
|
$
|
977,475
|
$
|
0
|
Related
Transactions
Prior
to
January 1, 1999, a portion of our general and administrative expenses resulted
from transactions with affiliated persons, and a number of capital transactions
also involved affiliated persons. Although these transactions were not the
result of "arms-length" negotiations, we do not believe that this fact had
a
material impact on our results of operations or financial position. Prior to
December 31, 1998, we classified certain payments to executive officers for
compensation and expense reimbursements as "Research and Development - related
party" and "General and Administrative - related party" because the executive
officers received such payments through personal services corporations rather
than directly. After December 31, 1998, these payments have been and will
continue to be accounted for as though the payments were made directly to the
officers, and not as a related party transaction. With the exception of our
arrangement with our management company described below, we do not foresee
a
need for, and therefore do not anticipate, any related party transactions in
the
current fiscal year.
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.
20
On
December 9, 2005, our Board of Directors approved a one-time recompense payment
in the aggregate amount of $1,000,000 for each of Ms. Gluskin, our Chairwoman,
Chief Executive Officer and President, 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 April 30, 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.
Real
Estate Transactions:
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 Ms. Gluskin 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 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 April
30,
2006 and 2007, we paid the management company approximately $11,864 and $11,721,
respectively, in management fees.
Legal
Fees.
David
Wires, a former director, 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.
Mr.
Wires elected not to stand for re-election at our annual meeting of stockholders
which was held on May 29, 2007.
Consulting
Fees.
Peter
Amanatides, one of our directors, is the Senior Vice-President and Chief
Operating Officer of PharmaLogika, Inc., a private consulting firm in the
pharmaceuticals regulatory field. During fiscal year 2006, Generex paid $150,000
in fees to PharmaLogika for services rendered. Subsequently, in fiscal 2007,
we
paid an additional $100,000 in fees to PharmaLogika for services rendered and
owe a balance of $50,000. We do not expect to pay any further fees to
PharmaLogika going forward. Mr. Amanatides is neither a director nor a
shareholder of PharmaLogika.
New
Accounting Pronouncements
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.
21
In
September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements" ("SFAS
157"). SFAS 157 defines fair value, establishes a framework for measuring fair
value in accordance with accounting principles generally accepted in the United
States, and expands disclosures about fair value measurements. SFAS No. 157
is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, with earlier application encouraged. Any amounts recognized
upon adoption as a cumulative effect adjustment will be recorded to the opening
balance of retained earnings in the year of adoption. We are currently
evaluating the impact of this statement on our results of operations or
financial position.
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. 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. We
are
currently evaluating the impact of this statement on our results of operations
or financial position.
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
April 30, 2007, we had fixed rate debt totaling $3,023,311. This amount consists
of the following:
Loan
Amount
|
Interest
Rate
per
Annum
|
|||
424,769
|
6.82%
|
|
||
263,366
|
6.82%
|
|
||
642,482
|
7.60%
|
|
||
358,440
|
8.50%
|
|
||
203,095
|
10%
|
|
||
1,131,158
|
6.07%
|
|
||
3,023,311
|
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.
22
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.
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.
None.
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 April 30, 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 calendar year 2007. To date, we have not been profitable and
our
accumulated net loss was $205,067,346 at April 30, 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.
With
the
exception of Generex Oral-lyn™ which is currently available for sale 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.
23
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, October 31, 2006 and January 31, 2007, we have
issued shares of our restricted common stock as partial consideration for the
provision of services by The Abajian Group, LLC (“Abajian”) under an agreement
with us. During the three months ended April 30, 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.
These
shares 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.
As
previously reported in our Annual Report on Form 10-K for the fiscal year ended
July 31, 2006 and our Quarterly Reports for the quarters ended October 31,
2006
and January 31, 2007, we have issued shares of our common stock to CEOcast,
Inc., a consultant, pursuant to an agreement to provide us with investor
relation services until August 21, 2007. During the three months ended April
30,
2007, we issued 75,000 shares of common stock to CEOcast 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 April 30, 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.
24
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)
|
|
|
|
|
|
4.2.1
|
|
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)
|
|
|
|
|
|
4.2.2
|
|
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)
|
|
|
|
|
|
4.2.3
|
|
Form
of Warrant issued in connection with Exhibit 4.2.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
|
|
4.2.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.2.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
4.3.1
|
|
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)
|
|
|
|
|
|
4.3.2
|
|
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)
|
|
|
|
|
|
4.3.3
|
|
Warrant
issued in connection with Exhibit 4.3.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
|
|
4.3.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.3.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.4.1
|
|
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)
|
|
|
|
|
|
4.4.2
|
|
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)
|
|
|
|
|
|
4.4.3
|
|
Warrant
issued in connection with Exhibit 4.4.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
|
25
4.4.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.4.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.5.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
|
|
4.5.2
|
|
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)
|
|
|
|
|
|
4.5.3
|
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
|
|
4.5.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.6.1
|
|
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)
|
|
|
|
|
|
4.6.2
|
|
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)
|
|
|
|
|
|
4.6.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.7.1
|
|
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)
|
|
|
|
|
|
4.7.2
|
|
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)
|
|
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.20 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 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.8.1
|
|
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)
|
|
|
|
|
|
4.8.2
|
|
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)
|
|
|
|
|
|
4.8.3
|
|
Form
of Warrant issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
|
|
4.8.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.8.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
|
|
4.9.1
|
|
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)
|
|
|
|
|
26
4.9.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
|
|
4.9.3
|
|
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)
|
|
|
|
|
|
4.9.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.9.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
|
|
4.9.5
|
|
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)
|
|
|
|
|
|
4.9.6
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.9.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
|
|
4.10
|
|
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)
|
|
|
|
|
|
4.11
|
|
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)
|
|
|
|
|
|
4.12
|
|
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)
|
|
|
|
|
|
4.13
|
|
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)
|
|
4.14.1
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
||
4.14.2
|
Form
of Additional AIRs issued in connection with Exhibit 4.14.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
||
4.15
|
|
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)
|
|
|
|
|
|
4.16.1
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
|
|
4.16.2
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
27
4.16.3
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
4.16.4
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
4.16.5
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006).
|
||
4.17.1
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
||
4.17.2
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
||
4.17.3
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
||
4.17.4
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
||
4.17.5
|
Form
of Additional Air Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
|
||
4.17.6
|
Form
of Additional Air Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
|
||
4.18.1
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
||
4.18.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
|
|
4.19
|
|
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).
|
|
4.20
|
|
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).
|
|
4.21.1
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
|
||
4.21.2
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.21.1 (incorporated by reference to Exhibit
4.2
to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
||
28
4.22.1
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
||
4.22.2
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.22.1 (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 4.9.1
(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.
|
29
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
|
|
|
GENEREX
BIOTECHNOLOGY CORPORATION
(Registrant)
|
|
|
|
|
Date:
June 11, 2007
|
By:
|
/s/ Anna
E. Gluskin
|
|
Anna
E. Gluskin
President
and Chief Executive Officer
|
|
|
|
|
|
|
|
Date:
June 11, 2007
|
By:
|
/s/ Rose
C. Perri
|
|
Rose
C. Perri
Chief
Financial Officer
|
|
|
|
30
Generex
Biotechnology Corporation
Form
10-Q
April
30,
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)
|
|
|
|
|
|
4.2.1
|
|
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)
|
|
|
|
|
|
4.2.2
|
|
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)
|
|
|
|
|
|
4.2.3
|
|
Form
of Warrant issued in connection with Exhibit 4.2.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
|
|
4.2.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.2.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
4.3.1
|
|
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)
|
|
|
|
|
|
4.3.2
|
|
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)
|
|
|
|
|
|
4.3.3
|
|
Warrant
issued in connection with Exhibit 4.3.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
|
|
4.3.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.3.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.4.1
|
|
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)
|
4.4.2
|
|
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)
|
|
|
|
|
4.4.3
|
|
Warrant
issued in connection with Exhibit 4.4.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
|
|
4.4.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.4.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.5.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
|
|
4.5.2
|
|
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)
|
|
|
|
|
|
4.5.3
|
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
|
|
4.5.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.6.1
|
|
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)
|
|
|
|
|
|
4.6.2
|
|
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)
|
|
|
|
|
|
4.6.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.7.1
|
|
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)
|
|
|
|
|
|
4.7.2
|
|
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)
|
|
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.20 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 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
|
|
4.8.1
|
|
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)
|
|
|
|
|
|
4.8.2
|
|
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)
|
|
|
|
|
|
4.8.3
|
|
Form
of Warrant issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
|
|
4.8.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.8.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
|
4.9.1
|
|
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)
|
|
|
|
|
|
4.9.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
|
|
4.9.3
|
|
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)
|
|
|
|
|
|
4.9.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.9.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
|
|
4.9.5
|
|
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)
|
|
|
|
|
|
4.9.6
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.9.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
|
|
4.10
|
|
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)
|
|
|
|
|
|
4.11
|
|
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)
|
|
|
|
|
|
4.12
|
|
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)
|
|
|
|
|
|
4.13
|
|
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)
|
|
4.14.1
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20, 2006)
|
||
4.14.2
|
Form
of Additional AIRs issued in connection with Exhibit 4.14.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
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4.15
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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)
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4.16.1
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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).
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4.16.2
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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).
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4.16.3
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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).
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4.16.4
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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).
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4.16.5
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006).
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||
4.17.1
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
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||
4.17.2
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
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||
4.17.3
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
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||
4.17.4
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
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||
4.17.5
|
Form
of Additional Air Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
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||
4.17.6
|
Form
of Additional Air Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
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||
4.18.1
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
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||
4.18.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
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4.19
|
|
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).
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4.20
|
|
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).
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4.21.1
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
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||
4.21.2
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.21.1 (incorporated by reference to Exhibit
4.2
to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
||
4.22.1
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
||
4.22.2
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.22.1 (incorporated by reference to Exhibit
4.4
to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
||
9
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|
Form
of Voting Agreement entered into in connection with Exhibit 4.9.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
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31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
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31.2
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
|
|
32
|
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002
|
|
||
(1) In
the case of incorporation by reference to documents filed by the
Registrant under the Exchange Act, the Registrant’s file number under the
Exchange Act is 000-25169.
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