GENEREX BIOTECHNOLOGY CORP - Quarter Report: 2007 October (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 October 31, 2007
o
TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934
For
the transition period from _________________ to
________________
COMMISSION
FILE NUMBER: 0-25169
GENEREX
BIOTECHNOLOGY CORPORATION
(Exact
name of registrant as specified in its charter)
|
Delaware
|
|
98-0178636
|
|
|
(State
of other jurisdiction of incorporation or
organization)
|
|
(IRS
Employer Identification No.)
|
|
33
HARBOUR SQUARE, SUITE 202
TORONTO,
ONTARIO
CANADA
M5J 2G2
(Address
of principal executive offices)
416/364-2551
(Registrant's
telephone number, including area code)
Not
applicable
(Former
name, former address and former fiscal year
if
changed since last report)
Indicate
by check mark whether the registrant: (1) has filed all reports required by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for the
past
90 days. x Yes o No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
|
Accelerated
filer x
|
Non-accelerated
filer o
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
o
Yes
x
No
The
number of outstanding shares of the registrant's common stock, par value $.001,
was 110,039,336 as of December 4, 2007.
GENEREX
BIOTECHNOLOGY CORPORATION
INDEX
PART
I. FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial Statements.
|
|
|
|
(Unaudited)
|
|
Consolidated
Balance Sheets -
|
|
October
31, 2007 and July 31, 2006
|
1
|
|
|
Consolidated
Statements of Operations — For the three month
|
|
Periods
ended October 31, 2007 and 2006, and cumulative from
|
|
November
2, 1995 to October 31, 2007
|
2
|
|
|
Consolidated
Statements of Cash Flows — For the three month
|
|
Periods
ended October 31, 2007 and 2006, and cumulative from
|
|
November
2, 1995 to October 31, 2007
|
3
|
|
|
Notes
to Consolidated Financial Statements
|
5
|
|
|
Item
2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
|
11
|
|
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
19
|
|
|
Item
4. Controls and Procedures
|
20
|
|
|
PART
II: OTHER INFORMATION
|
|
|
|
Item
1. Legal Proceedings
|
20
|
|
|
Item
1A. Risk Factors
|
21
|
|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
23
|
|
|
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
|
24
|
|
|
Signatures
|
29
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
BALANCE SHEETS
October
31,
|
|
July
31,
|
|
||||
|
|
2007
|
|
2007
|
|||
ASSETS
|
|||||||
Current
Assets:
|
|||||||
Cash
and cash equivalents
|
$
|
1,673,736
|
$
|
21,026,067
|
|||
Short-term
investments
|
27,585,336
|
14,011,738
|
|||||
Accounts
receivable
|
36,316
|
58,264
|
|||||
Inventory
|
278,206
|
123,931
|
|||||
Other
current assets
|
481,910
|
469,210
|
|||||
Total
Current Assets
|
30,055,504
|
35,689,210
|
|||||
Property
and Equipment, Net
|
2,145,472
|
2,137,027
|
|||||
Assets
Held for Investment, Net
|
4,090,385
|
3,693,183
|
|||||
Patents,
Net
|
4,885,300
|
4,884,984
|
|||||
TOTAL
ASSETS
|
$
|
41,176,661
|
$
|
46,404,404
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
6,913,495
|
$
|
7,156,709
|
|||
Deferred
revenue
|
47,178
|
33,314
|
|||||
Current
maturities of long-term debt
|
515,179
|
84,503
|
|||||
Total
Current Liabilities
|
7,475,852
|
7,274,526
|
|||||
Long-Term
Debt, Net
|
2,974,389
|
3,059,286
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
Equity:
|
|||||||
Special
Voting Rights Preferred Stock, $.001 par value; authorized
|
|||||||
1,000
shares at October 31, 2007 and July 31, 2007; -0- shares
|
|||||||
issued
and outstanding at October 31, 2007 and July 31, 2007
|
—
|
—
|
|||||
Common
stock, $.001 par value; authorized 500,000,000 shares at
|
|||||||
October
31, 2007 and July 31, 2007; 110,900,774 and 109,616,518
shares
|
|||||||
issued
and outstanding at October 31, 2007 and July 31, 2007,
respectively
|
110,900
|
109,616
|
|||||
Additional
paid-in capital
|
248,721,517
|
247,079,439
|
|||||
Deficit
accumulated during the development stage
|
(219,222,183
|
)
|
(212,000,270
|
)
|
|||
Accumulated
other comprehensive income
|
1,116,186
|
881,807
|
|||||
Total
Stockholders’ Equity
|
30,726,420
|
36,070,592
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
41,176,661
|
$
|
46,404,404
|
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
|
(Date
of Inception)
|
|||||||||
October
31,
|
to
October 31,
|
|||||||||
2007
|
|
2006
|
2007
|
|||||||
Revenues
|
$
|
46,427
|
$
|
139,005
|
$
|
2,423,152
|
||||
Sales
discounts
|
(1,714
|
)
|
—
|
(3,945
|
)
|
|||||
Net
Revenue
|
44,713
|
139,005
|
2,419,207
|
|||||||
Cost
of Goods Sold
|
19,931
|
31,515
|
81,554
|
|||||||
Operating
Expenses:
|
||||||||||
Research
and development
|
3,847,803
|
1,646,415
|
77,304,267
|
|||||||
Research
and development -
|
||||||||||
related
party
|
—
|
—
|
220,218
|
|||||||
Selling
and marketing
|
367,420
|
88,888
|
1,116,757
|
|||||||
General
and administrative
|
3,515,920
|
2,352,369
|
93,555,338
|
|||||||
General
and administrative -
|
||||||||||
related
party
|
—
|
—
|
314,328
|
|||||||
Total
Operating Expenses
|
7,731,143
|
4,087,672
|
172,510,908
|
|||||||
Operating
Loss
|
(7,706,361
|
)
|
(3,980,182
|
)
|
(170,173,255
|
)
|
||||
Other
Income (Expense):
|
||||||||||
Miscellaneous
income (expense)
|
—
|
—
|
196,193
|
|||||||
Income
from Rental Operations, net
|
82,087
|
71,499
|
1,003,015
|
|||||||
Interest
income
|
460,035
|
603,772
|
6,802,493
|
|||||||
Interest
expense
|
(57,674
|
)
|
(294,616
|
)
|
(43,659,689
|
)
|
||||
Loss
on extinguishment of debt
|
—
|
(58,518
|
)
|
(14,134,068
|
)
|
|||||
Net
Loss Before Undernoted
|
(7,221,913
|
)
|
(3,658,045
|
)
|
(219,965,311
|
)
|
||||
Minority
Interest Share of Loss
|
—
|
—
|
3,038,185
|
|||||||
Net
Loss
|
(7,221,913
|
)
|
(3,658,045
|
)
|
(216,927,126
|
)
|
||||
Preferred
Stock Dividend
|
—
|
—
|
2,295,057
|
|||||||
Net
Loss Available to Common
|
||||||||||
Shareholders
|
$
|
(7,221,913
|
)
|
$
|
(3,658,045
|
)
|
$
|
(219,222,183
|
)
|
|
Basic
and Diluted Net Loss Per
|
||||||||||
Common
Share
|
$
|
(.07
|
)
|
$
|
(.03
|
)
|
||||
Weighted
Average Number of Shares
|
||||||||||
of
Common Stock Outstanding
|
110,060,027
|
107,608,541
|
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 Three Months Ended
|
|
(Date
of Inception)
|
||||||||
October
31,
|
|
to
October 31,
|
||||||||
2007
|
|
2006
|
|
2007
|
||||||
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
$
|
(7,221,913
|
)
|
$
|
(3,658,045
|
)
|
$
|
(216,927,126
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
||||||||||
in
operating activities:
|
||||||||||
Depreciation
and amortization
|
306,569
|
288,593
|
6,188,515
|
|||||||
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
|
171,506
|
|||||||
Loss
on disposal of property and equipment
|
—
|
—
|
911
|
|||||||
Loss
on extinguishment of debt
|
—
|
58,518
|
14,134,069
|
|||||||
Common
stock issued as employee compensation
|
910,205
|
183,000
|
3,203,785
|
|||||||
Common
stock issued for services rendered
|
261,283
|
160,639
|
7,257,599
|
|||||||
Amortization
of prepaid services in conjunction with common
|
||||||||||
stock
issuance
|
—
|
—
|
138,375
|
|||||||
Non-cash
compensation expense
|
—
|
—
|
45,390
|
|||||||
Stock
options and warrants issued for services rendered
|
—
|
—
|
7,272,723
|
|||||||
Issuance
of warrants as additional exercise right inducement
|
—
|
—
|
21,437,909
|
|||||||
Preferred
stock issued for services rendered
|
—
|
—
|
100
|
|||||||
Treasury
stock redeemed for non-performance of services
|
—
|
—
|
(138,000
|
)
|
||||||
Amortization
of deferred debt issuance costs and loan
|
||||||||||
origination
fees
|
—
|
—
|
1,482,879
|
|||||||
Amortization
of discount on convertible debentures
|
—
|
223,319
|
18,930,427
|
|||||||
Common
stock issued as interest payment on convertible
|
||||||||||
debentures
|
—
|
10,628
|
284,459
|
|||||||
Interest
on short-term advance
|
—
|
—
|
22,190
|
|||||||
Founders’
shares transferred for services rendered
|
—
|
—
|
353,506
|
|||||||
Fees
in connection with short-term refinancing of
|
||||||||||
long-term
debt
|
—
|
—
|
113,274
|
|||||||
Changes
in operating assets and liabilities (excluding the
|
||||||||||
effects
of acquisition):
|
||||||||||
Accounts
receivable
|
15,632
|
(97,691
|
)
|
(41,048
|
)
|
|||||
Miscellaneous
receivables
|
—
|
—
|
43,812
|
|||||||
Inventory
|
(130,766
|
)
|
(18,552
|
)
|
(248,268
|
)
|
||||
Other
current assets
|
47,736
|
(143,487
|
)
|
(80,977
|
)
|
|||||
Accounts
payable and accrued expenses
|
159,076
|
(601,675
|
)
|
11,487,191
|
||||||
Deferred
revenue
|
12,824
|
—
|
45,855
|
|||||||
Other,
net
|
—
|
—
|
110,317
|
|||||||
Net
Cash Used in Operating Activities
|
(5,639,354
|
)
|
(3,591,656
|
)
|
(123,527,631
|
)
|
||||
Cash
Flows From Investing Activities:
|
||||||||||
Purchase
of property and equipment
|
(1,575
|
)
|
(42,496
|
)
|
(4,537,986
|
)
|
||||
Costs
incurred for patents
|
(81,527
|
)
|
(55,571
|
)
|
(1,899,129
|
)
|
||||
Change
in restricted cash
|
—
|
—
|
45,872
|
|||||||
Proceeds
from maturity of short term investments
|
4,181,210
|
7,841,384
|
162,264,019
|
|||||||
Purchases
of short-term investments
|
(17,754,808
|
)
|
(7,843,452
|
)
|
(189,849,355
|
)
|
||||
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
|
(33,566
|
)
|
(170,546
|
)
|
(736,856
|
)
|
||||
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
|
(13,690,266
|
)
|
(270,681
|
)
|
(38,013,170
|
)
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
3
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Cumulative
From
|
||||||||||
November
2, 1995
|
||||||||||
For
the Three Months Ended
|
(Date
of Inception)
|
|||||||||
October
31,
|
to
October 31,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
Cash
Flows From Financing Activities:
|
||||||||||
Proceeds
from short-term advance
|
—
|
—
|
325,179
|
|||||||
Repayment
of short-term advance
|
—
|
—
|
(347,369
|
)
|
||||||
Proceeds
from issuance of long-term debt
|
—
|
—
|
2,005,609
|
|||||||
Repayment
of long-term debt
|
(21,500
|
)
|
(18,305
|
)
|
(1,873,869
|
)
|
||||
Change
in due to related parties
|
—
|
—
|
154,541
|
|||||||
Proceeds
from exercise of warrants
|
—
|
125,000
|
44,015,049
|
|||||||
Proceeds
from exercise of stock options
|
—
|
153,133
|
4,554,126
|
|||||||
Proceeds
from minority interest investment
|
—
|
—
|
3,038,185
|
|||||||
Proceeds
from issuance of preferred stock
|
—
|
—
|
12,015,000
|
|||||||
Redemption
of SVR preferred stock
|
—
|
—
|
(100
|
)
|
||||||
Proceeds
from issuance of convertible debentures, net
|
—
|
—
|
20,254,930
|
|||||||
Repayments
of convertible debentures
|
—
|
—
|
(635,757
|
)
|
||||||
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
|
(21,500
|
)
|
259,828
|
163,186,308
|
||||||
Effect
of Exchange Rates on Cash
|
(1,211
|
)
|
(2,167
|
)
|
28,229
|
|||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(19,352,331
|
)
|
(3,604,676
|
)
|
1,673,736
|
|||||
Cash
and Cash Equivalents, Beginning of Period
|
21,026,067
|
38,208,493
|
—
|
|||||||
Cash
and Cash Equivalents, End of Period
|
$
|
1,673,736
|
$
|
34,603,817
|
$
|
1,673,736
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
4
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. |
Basis
of Presentation
|
The
accompanying unaudited interim consolidated financial statements have been
prepared pursuant to the rules and regulations for reporting on Form 10-Q.
Accordingly, certain information and disclosures required by generally accepted
accounting principles for complete financial statements are not included herein.
The interim statements should be read in conjunction with the financial
statements and notes thereto included in the Company’s latest Annual Report on
Form 10-K. The results for the three 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 2008. In the Company’s
opinion, all adjustments necessary for a fair presentation of these interim
statements have been included and are of a normal and recurring
nature.
The
Company is a development stage company, which has a limited history of
operations and whose revenues is primarily comprised of $1 million received
in
conjunction with the execution of a development agreement, grant revenue from
government agencies related to Antigen’s operations and $50,000 in conjunction
with the execution of a licensing agreement. The Company has realized minimal
revenues to date from the sale of its commercial products, which currently
consists of four commercially available products, including Glucose
RapidSprayTM.
Additionally, the Company has several product candidates that are in various
research or early stages of pre-clinical and clinical development. There can
be
no assurance that the Company will be successful in obtaining regulatory
clearance for the sale of existing or any future products or that any of the
Company’s products will be commercially viable.
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
|
Reclassifications
Certain
prior period balances have been reclassified in order to conform to the current
period presentation. Such reclassifications have no effect on prior period’s net
loss.
3. |
Effects
of Recent Accounting
Pronouncements
|
The
Company has adopted the provisions of FASB Interpretation No. 48, “Accounting
for Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109”
(“FIN 48”), on August 1, 2007. FIN 48 clarifies the accounting for uncertainty
in income taxes recognized in an enterprise’s financial statements in accordance
with FASB Statement 109 “Accounting for Income Taxes”, and prescribes a
recognition threshold and measurement process for financial statement
recognition and measurement of a tax position taken or expected to be taken
in a
tax return. FIN 48 also provides guidance on derecognition classification,
interest and penalties accounting in interim periods disclosure and
transition.
Based
on
our evaluation, we have concluded that there are no significant uncertain tax
positions requiring recognition in our financial statements or adjustments
to
our deferred tax assets and related valuation allowance. Our evaluation was
performed for the tax years ended July 31, 2007, 2006, 2005 and 2004, the tax
years which remain subject to examination by major tax jurisdictions as of
October 31, 2007.
5
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements" ("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. On November 15, 2007,
the
FASB granted a one year deferral for non-financial assets and liabilities to
comply with SFAS No. 157, however, the effective date for financial assets
remains intact. 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 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. The
Company is currently evaluating this pronouncement in connection with SFAS
No.
157.
4.
|
Stock-Based
Compensation
|
As
of
October 31, 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 the
2006
Plan. At October 31, 2007, there were 1,940,000, 1,182,490 and 8,012,000 shares
of common stock reserved for future awards under the 2000 Plan, 2001 Plan and
2006 Plan, respectively.
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.
6
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 vest from zero to 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 three months ended October 31,
2007.
The
summary of the stock option activity for the three months ended October 31,
2007
is as follows:
Weighted
|
Weighted
|
||||||||||||
Average
|
Average
|
||||||||||||
Exercise
|
Remaining
|
Aggregate
|
|||||||||||
Price
|
Contractual
|
Intrinsic
|
|||||||||||
Shares
|
Share
|
Term
(Years)
|
Value
|
||||||||||
Outstanding,
August 1, 2007
|
7,962,638
|
$
|
0.94
|
||||||||||
Granted
|
—
|
$
|
—
|
||||||||||
Forfeited
or expired
|
—
|
$
|
—
|
||||||||||
Exercised
|
—
|
$
|
—
|
||||||||||
Outstanding,
October 31, 2007
|
7,962,638
|
$
|
0.94
|
1.59
|
$
|
5,521,979
|
|||||||
Exercisable,
October 31, 2007
|
7,962,638
|
$
|
0.94
|
1.59
|
$
|
5,521,979
|
|||||||
$
|
n/a
|
||||||||||||
Total
Intrinsic Value of Options Exercised
|
$
|
n/a
|
As
of
October 31, 2007, all stock options outstanding are vested. Accordingly, there
was no unrecognized compensation related to non-vested stock options granted
under the Company’s stock option plans.
A
total
of 396,000 shares of restricted and 150,000 shares of unrestricted common stock
were granted to employees, consultants and advisors during the three months
ended October 31, 2007 fair valued at $828,920 and has been included in the
statement of operations (see Note 10).
7
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
August
2007, the Company issued 550,000 shares of common stock under the 2006 Plan
in
the form of restricted stock awards to officers. The fair value of these shares
based on the quoted market price of the Company’s common stock on the dates of
the issuance is $830,500. These shares were issued as an incentive to retain
key
employees and officers. A portion of these shares vested immediately while
the
remaining portion will vest over two years from the date of the grant. The
following table summarizes the Company’s non-vested restricted stock activity
for the three months ended October 31, 2007:
Weighted
|
|||||||
Average
|
|||||||
Grant
Date
|
|||||||
Number
of
|
Fair
|
||||||
Shares
|
Value
|
||||||
Non-vested
stock, August 1, 2007
|
—
|
$
|
—
|
||||
Granted
|
550,000
|
1.51
|
|||||
Vested
|
(312,500
|
)
|
1.51
|
||||
Forfeited
|
—
|
—
|
|||||
Non-vested
stock, October 31, 2007
|
237,500
|
$
|
1.51
|
As
of
October 31, 2007, approximately $303,000 of total unrecognized compensation
costs related to unvested shares is expected to be recognized over the remaining
service period of 2 years.
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 October 31, 2007 and
2006,
was $6,987,534 and $3,640,361, respectively.
6.
|
Accounts
Payable and Accrued
Expenses
|
Accounts
payable and accrued expenses consist of the following:
October
31,
|
July
31,
|
||||||
2007
|
2007
|
||||||
Accounts
Payable
|
$
|
2,615,729
|
$
|
1,791,080
|
|||
Research
and Development
|
1,954,176
|
1,956,049
|
|||||
Executive
Compensation
|
1,713,560
|
2,252,978
|
|||||
630,030
|
1,156,602
|
||||||
Total
|
$
|
6,913,495
|
$
|
7,156,709
|
8
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
7.
|
Pending
Litigation
|
In
February 2001, a former business associate of the former Vice President of
Research and Development (VP) of the Company, and an entity 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 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.
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.
8.
|
Net
Loss Per Share
|
Basic
EPS
and Diluted EPS for the three months ended October 31, 2007 and 2006 have been
computed by dividing the net loss for each respective period by the weighted
average number of shares outstanding during that period. All outstanding
warrants, options and non-vested restricted stock, approximately 22,814,296
incremental shares, at October 31, 2007 have been excluded from the computation
of Diluted EPS as they are anti-dilutive. All outstanding warrants, options
and
shares issuable upon conversion of convertible debentures, approximately
23,894,549 incremental shares, at October 31, 2006 have been excluded from
the
computation of Diluted EPS as they are anti-dilutive.
9
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
9.
|
Supplemental
Disclosure of Cash Flow
Information
|
For
the Three Months Ended
|
|||||||
October
31,
|
|||||||
2007
|
2006
|
||||||
Cash
paid during the period for:
|
|||||||
Interest
|
$
|
57,673
|
$
|
56,265
|
|||
Income
taxes
|
$
|
—
|
$
|
—
|
|||
Disclosure
of non-cash investing and financing activities:
|
|||||||
Issuance
of common stock in conjunction with convertible
|
|||||||
debenture
conversion
|
$
|
—
|
$
|
230,769
|
|||
executive
compensation
|
$
|
471,875
|
$
|
—
|
10.
|
Stockholders’
Equity
|
During
the three months ended October 31, 2007, the Company issued 171,684 shares
of
common stock to various consultants for services rendered in the amount of
$261,283. The shares were valued at $1.48 to $1.61 per share based on the quoted
market price of the Company’s common stock on the dates of the
issuances.
During
the three months ended October 31, 2007, the Company issued 562,542 shares
of
common stock valued at $854,170 as employee compensation including 546,000
shares issued under 2006 Stock Option Plan (see Note 4). The shares were valued
at $1.50 to $1.55 per share based on the quoted market price of the Company’s
common stock on the dates of the issuances.
During
the three months ended October 31, 2007, the Company issued 550,000 shares
of
restricted common stock valued at $830,500 as executive compensation to officers
of the Company, 312,500 shares of which were issued as satisfaction of accrued
executive compensation amounting to $471,875. The shares were valued at $1.51
per share based on the quoted market price of the Company’s common stock on the
dates of the issuances. These shares vest over a period of two years from the
date of the grant (see Note 4).
The
issuances of common stock as described above are summarized as
follow:
Additional
|
Total
|
||||||||||||
Common
Stock
|
Paid-In
|
Stockholders’
|
|||||||||||
Shares
|
Amount
|
Capital
|
Equity
|
||||||||||
Issuance
for Services
|
171,684
|
$
|
172
|
$
|
261,111
|
$
|
261,283
|
||||||
Issuance
as Employee Compensation
|
562,542
|
563
|
853,607
|
854,170
|
|||||||||
Issuance
as Executive Compensation
|
550,000
|
550
|
(550
|
)
|
—
|
||||||||
Stock-based
Executive Compensation
|
—
|
—
|
56,035
|
56,035
|
|||||||||
Satisfaction
of Accrued Executive
|
|||||||||||||
Compensation
|
—
|
—
|
471,875
|
471,875
|
|||||||||
Total
|
1,284,226
|
$
|
1,285
|
$
|
1,642,078
|
$
|
1,643,363
|
10
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-month periods ended
October 31, 2007 and 2006. 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, as amended, for the year ended July 31, 2007 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 October 31,
2007.
Forward-Looking
Statements
We
have
made statements in this Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
and
elsewhere in this Quarterly Report on Form 10-Q of Generex Biotechnology
Corporation for the fiscal quarter ended October 31, 2007 that may constitute
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 (the "Act"). The Act limits our liability in
any
lawsuit based on forward-looking statements that we have made. All statements,
other than statements of historical facts, included in this Quarterly Report
that address activities, events or developments that we expect or anticipate
will or may occur in the future, including such matters as our projections,
future capital expenditures, business strategy, competitive strengths, goals,
expansion, market and industry developments and the growth of our businesses
and
operations, are forward-looking statements. These statements can be identified
by introductory words such as "expects," "plans," "intends," "believes," "will,"
"estimates," "projects," “predicts,” “foresees” or words of similar meaning, and
by the fact that they do not relate strictly to historical or current facts.
Our
forward-looking statements address, among other things:
|
·
|
our
expectations concerning product candidates for our
technologies;
|
|
|
|
|
·
|
our
expectations concerning existing or potential development and license
agreements for third-party collaborations and joint
ventures;
|
|
|
|
|
·
|
our
expectations of when different phases of clinical activity may
commence;
|
|
|
|
|
·
|
our
expectations of when regulatory submissions may be filed or when
regulatory approvals may be received; and
|
|
|
|
|
·
|
our
expectations of when commercial manufacture and commercial sales
of our
products may commence and when actual revenue from the product sales
may
be received.
|
Any
or
all of our forward-looking statements may turn out to be wrong. They may be
affected by inaccurate assumptions that we might make or by known or unknown
risks and uncertainties. Actual outcomes and results may differ materially
from
what is expressed or implied in our forward-looking statements. Among the
factors that could affect future results are:
|
·
|
the
inherent uncertainties of product development based on our new and
as yet
not fully proven technologies;
|
|
|
|
|
·
|
the
risks and uncertainties regarding the actual effect on humans of
seemingly
safe and efficacious formulations and treatments when tested
clinically;
|
|
|
|
|
·
|
the
inherent uncertainties associated with clinical trials of product
candidates;
|
|
|
|
|
·
|
the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product candidates;
|
|
|
|
|
·
|
the
inherent uncertainties associated with commercialization of products
that
have received regulatory approval;
and
|
|
·
|
our
ability to obtain the necessary financing to fund our
operations.
|
11
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, 2007, 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.
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 using a hand-held aerosol applicator. Through
our wholly-owned subsidiary, Antigen Express, Inc., we are expanding our focus
to include immunomedicines. We operate in only one segment: the research,
development and commercialization of drug delivery systems and technologies
for
metabolic and immunological diseases.
We
have a
limited number of products that are ready for commercial marketing and sale:
our
oral insulin formulation, Generex Oral-lyn™, has been approved for commercial
marketing and sale in Ecuador and India; and our over-the-counter line glucose
spray products utilizing our proprietary buccal delivery technology have been
launched in retail outlets in the United States and Canada.
We
have
begun the regulatory approval process for six pharmaceutical 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
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.
We
are a
development stage company. From inception through the end of the year ended
July
31, 2006, we have received only limited revenues from operations. Pursuant
to a
development and license agreement that we entered into with Eli Lilly and
Company in September 2000 and terminated as of June 2003, we received a
$1,000,000 upfront payment. In the fiscal year ended July 31, 2007, we received
approximately $136,448 in revenues from sales of Glucose RapidSpray™. In the
three-month period ending October 31, 2007, we received approximately $44,713
in
revenues from sales of Glucose RapidSpray™ . This number does not reflect sales
to the customers with the right or return during the period that were
deferred.
Strategy
Generex
Oral-lyn™
In
fiscal
2008, our efforts will focus on enrolling patients and dosing of late-stage
clinical trials of Generex Oral-lyn™ in the United States, Canada and Europe and
preparing for the commercialization of Generex Oral-lyn™ in Ecuador and India.
We
have
identified key vendors for the management of Phase III clinical trials of
Generex Oral-lyn™ and have selected centers to conduct such trials in the United
States, Canada, Europe and Eastern Europe. In anticipation of undertaking
late-stage clinical trials globally, we have engaged consultants to assist
with
the design and implementation of clinical trials and regulatory strategies
and
have secured a manufacturer to produce clinical trial batches of Generex
Oral-lyn™. We have contracted with our third-party manufacturers for sufficient
quantities of the RapidMist™ device components, the insulin, and the formulary
excipients that will be required for the production of clinical trial batches
of
Generex Oral-lyn™. Patient enrollment is expected to begin at some of the sites
during the fourth quarter of calendar year 2007 with the first dosing taking
place in early 2008 and expand to several global centers over the course of
the
study. The primary objective of the study is to compare the efficacy of Generex
Oral-lyn™ and the RapidMist™ Diabetes Management System with that of standard
regular injectable human insulin therapy as measured by HbA1c, in patients
with
Type-1 diabetes mellitus. We expect to use the data collected from these trials
in the New Drug Submission that will be prepared concurrently with the
progression of the late-stage trials for Health Canada, European Union (EMEA)
and the U.S. Food and Drug Administration (FDA).
12
In
early
November 2007, Generex Oral-lyn™ was approved for importation and commercial
marketing and sale in India for the treatment of diabetes by the Central Drugs
Standard Control Organization (CDSCO), Directorate General of Health Services,
Government of India, which is responsible for authorizing marketing approval
of
all new pharmaceutical products in India. In connection with this approval,
we
entered into a Product Licensing and Distribution Agreement with Shreya Life
Sciences Pvt. Ltd., a leading Indian-based pharmaceutical company and the fourth
largest distributor of insulin in the Indian insulin product market. We are
working with Shreya to prepare for the commercial launch of Generex Oral-lyn™ in
India in early calendar year 2008. Preparations include marketing plans and
post-approval clinical studies. We do not expect to receive revenues from the
sale of this product in India in fiscal 2008.
In
fiscal
2008, we also plan to continue with the commercialization of Generex Oral-lyn™
in Ecuador and efforts to obtain regulatory approval of this product in other
countries using the approved Ecuadorian dossier. Our business partner for the
commercialization of Generex Oral-lyn™ in Ecuador, PharmaBrand, S.A., expects
additional commercial manufacturing runs of the product at its facilities in
Quito, Ecuador in the early calendar year 2008. We are also working with
Pharmabrand to expand extant production facilities to meet the anticipated
demand for the product in India and other jurisdictions where governmental
approvals are pending. Currently, our relationship with PharmaBrand is governed
by a letter of intent, and we are in the process of transitioning PharmaBrand’s
role into one of a third-party manufacturer with distribution rights for
Ecuador. PharmaBrand has generated some commercial sales of Generex Oral-lyn™ in
Ecuador to date. While we expect to receive revenues from such sales sometime
in
fiscal 2008, 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
the
fiscal quarter ended October 31, 2007, we entered into licensing and
distribution agreements with three multinational distributors to initiate the
regulatory approval and commercialization process for Generex Oral-lyn™ in three
geographic areas: South Africa and six neighboring African countries; 15 Middle
Eastern countries; and the Republic of Armenia, Georgia and the Republic of
Kazakhstan.
We
face
competition from other providers of alternate forms of insulin. One of our
most
significant competitors, Pfizer, announced in mid-October that it would no
longer sell or produce its inhalable form of insulin, marketed as Exubera®, due
to disappointing sales and failure to gain acceptance with patients and
physicians. We believe that our buccal delivery technology offers several
advantages over inhaled insulin, including: the avoidance of pulmonary
inhalation, which requires frequent physician monitoring, ease of use and
portability.
Buccal
Glucose and Energy Products - Glucose RapidSpray™, BaBOOM! ™ Energy Spray and
GlucoBreak™
With
the
recent launch of commercial sales of our over-the-counter oral glucose and
energy spray products, GlucoBreak™ and BaBOOM!™ Energy Spray, in retail outlets
in the United States and Canada, we expect to receive increased revenues from
product sales in fiscal 2008. We plan to achieve this by increasing our
over-the-counter product line to three products - the two products mentioned
above and Glucose RapidSpray™ - and expanding our existing distribution
channels. In addition, we will increase our advertising and marketing efforts
of
our products and expand the availability of our products from North America
to
the rest of the world. This strategy has already been effected by the execution
of licensing and distribution agreements with Leosons General Trading Company
for the distribution and sale of our over-the-counter products in 15 Middle
Eastern countries and Adcock Ingram LLP and Adcock Ingram Healthcare (Pty)
Ltd.
for the distribution and sale of Glucose RapidSpray ™ in South Africa and six
neighboring countries.
Metformin
Gum Product/Strategic Alliance
During
fiscal 2008, we 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. We plan to have clinical material
produced and initiate pre-clinical studies in calendar 2008.
Immunomedicine
Technology and Products
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, has commenced Phase I clinical trials with the same compound as an
immunotherapeutic vaccine for prostate cancer. 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.
13
Financing
We
project that revenues generated from sales of both our glucose and energy spray
products in the U.S. and Canada and sales of Generex Oral-lyn™ in Ecuador will
not be sufficient for all of our cash needs during fiscal year 2008. In the
past
we were able to fund Antigen expenses with some revenue from research grants
for
Antigen's immunomedicine products. During the fiscal quarter ended October
31,
2007, we did not receive any of such research grants. We do not expect to
receive such grants on a going forward basis.
We
expect
to satisfy the majority of our cash needs during the current year from 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 the fiscal years ending
July 31, 2005 and 2006, we believe that we have secured the funds necessary
to
continue in the short term with the commercialization of Generex Oral-lyn™ in
Ecuador and India, to seek regulatory approval for this product in certain
other
countries and to pursue late-stage clinical trials of this product in the United
States, Canada and Europe. We also project that we will have the funds to
support further research and development and limited clinical testing of
technology created by Antigen.
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. We
are
also looking into procurement of the reliable insulin supply for our future
commercial needs.
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 last fiscal quarter, we expended resources on the clinical testing and
commercialization, of our buccal insulin product, Generex Oral-lyn™. In July
2007, we received no objection from the FDA to proceed with our long-term
multi-center Phase III study protocol for Generex Oral-lyn™. Late-stage trials
involve testing our product with a large number of patients over a significant
period of time. The completion of late-stage trials in Canada and eventually
the
United States may require significantly greater funds than we currently have
on
hand.
Generex
Oral-lyn™ was approved for commercial sale by drug regulatory authorities in
Ecuador in May 2005. PharmaBrand handled the commercial launch of Generex
Oral-lyn™ in Ecuador in June 2006. While we anticipate generating revenue from
sales of Generex Oral-lyn™ in Ecuador in fiscal 2008, we do not expect that such
revenues will be sufficient to sustain our research and development and
regulatory activities.
Generex
Oral-lyn™ was approved for importation and commercial sale in India in November
2007. We have entered into a licensing and distribution agreement with Shreya
Life Sciences Pvt. Ltd. and are working with Shreya to prepare for the
commercial launch of the product in India. We do not expect to receive revenues
from the sale of Generex Oral-lyn™ in India in fiscal 2008.
14
Although
we initiated regulatory approval process for our morphine and fentanyl buccal
products, we did not expend resources to further this product during our last
fiscal year.
During
the last fiscal quarter, 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
in
the United States involving patients with HER-2/neu positive breast cancer,
and
an Antigen vaccine for H5N1 avian influenza is in Phase I clinical trials
conducted at the Lebanese-Canadian Hospital in Beirut. Antigen’s prostate cancer
vaccine based on AE37 is currently in Phase I clinical trials in Greece.
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, our ability
to
enter into collaborative marketing and distribution agreements with
third-parties, and the success of such marketing and distribution arrangements.
For the same reasons, we cannot predict when any products may begin to produce
net cash inflows.
Most
of
our buccal delivery research and development activities to date have involved
developing our platform technology for use with insulin. Insubstantial amounts
have been expended on projects with other drugs, including morphine and
fentanyl, and those projects involved a substantial amount of platform
technology development. As a result, we have not made significant distinctions
in the accounting for research and development expenses among products, as
a
significant portion of all research has involved improvements to the platform
technology in connection with insulin, which may benefit all of our potential
buccal products. During the quarter ended October 31, 2007, approximately 84%
of
our $3,847,803 in research expenses was attributable to insulin and platform
technology development, and we did not have any research expenses related to
morphine, fentanyl or other buccal projects. During the quarter ended October
31, 2006, approximately 68% of our $1,592,933 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.
Approximately16%
or $635,980 of our research and development expenses for the quarter ended
October 31, 2007 was related to Antigen's immunomedicine products
compared to approximately 32% or $509,408 for the quarter ended October 31,
2006. Because these products are in initial phases of clinical trials or early,
pre-clinical stage of development (with the exception of the Phase II clinical
trials of Antigen HER-2/neu positive breast cancer vaccine that are underway),
all of the expenses were accounted for as basic research and no distinctions
were made as to particular products. 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 October 31, 2007 Compared to Three Months Ended October 31,
2006
Our
net
loss for the quarter ended October 31, 2007 was $7,221,913 versus $3,658,045
in
the corresponding quarter of the prior fiscal year. The increase in net loss
in
this fiscal quarter versus the corresponding quarter of the prior fiscal year
is
primarily due to the increase in research and development activities in
connection with Phase III. Our operating loss for the quarter ended October
31,
2007 increased to $7,706,361 compared to $3,980,182 in the first fiscal quarter
of 2006. The increase resulted from an increase in general and administrative
expenses (to $3,515,920 from $2,352,369), and an increase in research and
development expenses (to $3,847,803 from $1,646,415). Our revenues in the first
quarter ended October 31, 2007 decreased to $44,713 from $139,005 for the
quarter ended October 31, 2006. Our operating loss for the quarter ended October
31, 2007 also included $367,420 in selling and marketing expenses, compared
to
$88,888 in the same period last year.
The
increase in general and administrative expenses for the quarter ended October
31, 2007 is due primarily to the increase of legal, accounting and consulting
expenses. Our higher advertising and sponsorship expenses as well as travel
expenses and executive compensation also contributed to the increase in the
current period compared to the same period last year.
The
increase in research and development expenses for the quarter ended October
31,
2007 reflects increased levels of research and development activities in
connection with commencement of Phase III clinical trials of Generex Oral-lyn™
in Canada and higher level of clinical activities of Antigen.
Our
interest expense in the first fiscal quarter of 2008 decreased to $57,674
compared to interest expense of $294,616 in the first fiscal quarter of 2007
since all of our convertible debentures were repaid prior to the first fiscal
quarter of 2008. Our loss on extinguishment of debt, also incurred in connection
with convertible debentures, was $0 in the first fiscal quarter of 2008 compared
to $58,518 in the same quarter for the last year. Our interest income decreased
to $460,035 in the first fiscal quarter of 2008 compared to $603,772 in the
same
quarter for the last year primarily due to lower cash and short term investment
balances during the current fiscal quarter. We received a slightly higher income
from rental operations (net of expense) of $82,087 in the first fiscal quarter
of 2008 compared to $71,499 in the same quarter for the last year.
15
Developments
In
September and October 2007, we entered into licensing and distribution
agreements with Adcock Ingram LLP and Adcock Ingram Healthcare (Pty) Ltd.,
a
leading distributor of North American pharmaceutical and healthcare products
in
South Africa, for the marketing and distribution of Generex Oral-lyn™ and
Glucose RapidSpray ™ in South Africa and six neighboring countries. Under these
agreements, we will not receive an upfront license fee, but Adcock Ingram will
bear all costs associated with the procurement of governmental approvals for
the
sale of the products, including any clinical and regulatory costs.
In
October 2007, we announced that our Middle Eastern master licensee, Leosons
General Trading Company, had filed submissions of the Generex Oral-lyn™ dossier
with regulatory agencies in Kuwait, Qatar, Jordan, Yemen, and the United Arab
Emirates. The objective of these submissions is to procure requisite
governmental approvals for the importation, marketing, distribution, and sale
of
Generex Oral-lyn™ in those jurisdictions.
In
November 2007, Generex Oral-lyn™ became the first non-injectable buccal insulin
approved for importation and commercial marketing and sale in India for the
treatment of diabetes.
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.
During
the fiscal quarter ended October 31, 2007, we did not engage in any
capital-raising transactions. At October 31, 2007, we had cash and short-term
investments of approximately $29.3 million, a decrease of $5.8 million from
the
balance as of the end of the prior fiscal year. As of October 31, 2007, we
believed that our anticipated cash position was sufficient to meet our working
capital needs for the next twelve months based on the pace of our planned
activities. Beyond that, we may require additional funds to support our working
capital requirements or for other purposes. Management plans to meet our
operating cash flow requirements through financing activities, such as private
placement of our common stock, preferred stock offerings and offerings of debt
and convertible debt instruments. Management is also actively pursuing industry
collaboration activities, including product licensing and specific project
financing. We are also looking into procurement of the reliable insulin supply
for our future commercial needs. While we have generally been able to raise
equity capital as required, our cash balances were very low during portions
of
fiscal 2005 and unforeseen problems with our clinical program, manufacturing
and
commercialization plans in Ecuador and India 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
October 31, 2007, the following warrants issued under the auspices of the
Securities Purchase Agreement dated November 10, 2004 and amendments thereto
and
the Securities Purchase Agreement dated June 1, 2006 were
outstanding:
Date
Issued
|
Aggregate
No.
of
Shares Unexercised
|
Exercise
Price*
|
Exercise
Date
|
Expiration
Date
|
|||||||||
January
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
16
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™, BaBOOM!™ Energy Spray and GlucoBreak™ 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. In the event where the customers have the right of return, sales are
deferred until the right of return lapses or the product is resold.
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 the lower cost or market is used. As appropriate, a provision is
recorded to reduce inventories to their net realizable value. Inventory also
includes the cost of products sold to the customers with the rights of
return.
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
|
3,489,568
|
515,179
|
2,251,629
|
722,761
|
0
|
|||||||||||
Capital
Lease Obligations
|
0
|
0
|
0
|
0
|
0
|
|||||||||||
Operating
Lease Obligations
|
565,962
|
116,547
|
264,348
|
184,512
|
555
|
|||||||||||
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
|
$
|
4,055,530
|
$
|
631,725
|
$
|
2,515,977
|
$
|
907,273
|
$
|
555
|
17
Certain
Relationships and Related Transactions
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.
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 December 10, 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 October
31, 2007 and 2006, we paid the management company approximately $13,141 and
$11,856, respectively, in management fees. We believe that the amounts paid
to
the management company approximate the rates that would be charged by a
non-affiliated property management company.
18
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 2007, we paid
approximately $95,000 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 2008.
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 2007, Generex paid $100,000
in fees to PharmaLogika for services rendered, and we 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
We
adopted the provisions of FASB Interpretation No. 48, “Accounting for
Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109” (“FIN
48”), on August 1, 2007. FIN 48 clarifies the accounting for uncertainty in
income taxes recognized in an enterprise’s financial statements in accordance
with FASB Statement 109 “Accounting for Income Taxes”, and prescribes a
recognition threshold and measurement process for financial statement
recognition and measurement of a tax position taken or expected to be taken
in a
tax return. FIN 48 also provides guidance on derecognition classification,
interest and penalties accounting in interim periods disclosure and
transition.
Based
on
our evaluation, we have concluded that there are no significant uncertain tax
positions requiring recognition in our financial statements or adjustments
to
our deferred tax assets and related valuation allowance. Our evaluation was
performed for the tax years ended July 31, 2007, 2006, 2005 and 2004, the tax
years which remain subject to examination by major tax jurisdictions as of
October 31, 2007.
We
may
from time to time be assessed interest or penalties by major tax jurisdictions,
although such assessments historically have been minimal and immaterial to
our
financial results. In the event we have received an assessment for interest
and/or penalties, it has been classified in the financial statements as general
and administrative expense.
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. On November 15, 2007,
the
FASB granted a one year deferral for non-financial assets and liabilities to
comply with SFAS No. 157, however, the effective date for financial assets
remains intact. 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.
19
As
of
October 31, 2007, we had fixed rate debt totaling $3,489,568. This amount
consists of the following:
Loan
Amount
|
Interest
Rate
per
Annum
|
|||
489,567
|
6.82
|
%
|
||
303,543
|
6.82
|
%
|
||
741,239
|
7.60
|
%
|
||
419,120
|
8.50
|
%
|
||
232,557
|
10
|
%
|
||
1,303,542
|
6.07
|
%
|
||
3,489,568
|
Total
|
These
debt instruments mature from August 2008 through June 2011. As our fixed rate
debt instruments mature, we will likely refinance such debt at the existing
market interest rates which may be more or less than interest rates on the
maturing debt. Since this debt is fixed rate debt, if interest rates were to
increase 100 basis points prior to maturity, there would be no impact on
earnings or cash flows.
We
have
neither issued nor own any long-term debt instruments, or any other financial
instruments, for trading purposes and as to which we would be subject to
material market risks.
Item
4. Controls and Procedures.
Evaluation
of disclosure controls and procedures
Prior
to
the filing of this Quarterly Report on Form 10-Q, an evaluation was performed
under the supervision of and with the participation of our management, including
our Chief Executive Officer and Chief Financial Officer, of the effectiveness
of
our disclosure controls and procedures. Based on the evaluation our Chief
Executive Officer and Chief Financial Officer have concluded that, as of the
end
of the period covered by this Quarterly Report of Form 10-Q, the Company’s
disclosure controls and procedures were effective to ensure that information
required to be disclosed by the Company in reports that it files or submits
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is
recorded, processed, summarized and reported within the time periods specified
in the rules and forms of the SEC and is accumulated and communicated to the
Company’s management, as appropriate, to allow timely decisions regarding
required disclosures.
Changes
in internal control over financial reporting
There
was
no change in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15(d)-15(f) under the Exchange Act) during the period covered
by
this Quarterly Report on Form 10-Q that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
Shemano
Group, Inc.
On
September 26, 2006, Shemano Group, Inc. initiated a National Association of
Securities Dealers arbitration proceeding against us. Shemano claimed it was
entitled to be paid fees pursuant to a finder’s agreement in connection with
certain private placements effected by us The arbitration hearing took place
in
June 2007. In July 2007, the arbitration panel awarded Shemano an aggregate
of
$1,030,545 in cash in compensatory damages. A third party subsequently initiated
an arbitration proceeding claiming an entitlement to 60% of the award.
Consequently, we paid 40% of the award to Shemano in September 2007. After
the
remaining portion of the award ($618,327) was paid in early November 2007 to
Shemano, the arbitration proceedings were closed.
20
We
are
involved in certain other legal proceedings in addition to those specifically
described herein. Subject to the uncertainty inherent in all litigation, we
do
not believe at the present time that the resolution of any of these legal
proceedings is likely to have a material adverse effect on our financial
position, operations or cash flows.
With
respect to all litigation matters, as additional information concerning the
estimates used by us becomes known, we reassess each matter’s position both with
respect to accrued liabilities and other potential exposures.
Item
1A. Risk Factors.
In
addition to the other information included in this Quarterly Report on Form
10-Q, you should carefully review and consider the factors discussed in
Part
I, Item 1A - Risk Factors
of our
Annual Report on Form 10-K for the year ended July 31, 2007, 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 quarter ended October 31, 2007, we received nominal
revenues from sales of Glucose RapidSpray™ . We did not recognize any revenue
from the sale of our oral insulin product in Ecuador in fiscal 2007 and do
not
expect to receive any until we enter into a final agreement with PharmaBrand
to
manufacture commercial orders of Generex Oral-lyn™ and to continue its marketing
and sales efforts in Ecuador in 2008 with a focus on that portion of the
population with the newly identified condition closely related to diabetes
known
as Impaired Glucose Tolerance (IGT). Individuals with IGT usually do not meet
the criteria for the diagnosis of diabetes mellitus but experience abnormally
high blood glucose levels several hours after a meal. While Generex Oral-lyn™
was approved for importation and commercial marketing and sale in India in
November 2007, we do not expect to receive any revenues from sales of the
product in fiscal 2008. We have entered into a licensing and distribution
agreement with a leading Indian-based pharmaceutical company and insulin
distributor and have begun preparations for commercial launch in India in early
2008 calendar year.
To
date,
we have not been profitable and our accumulated net loss was $219,222,183 at
October 31, 2007. Our losses have resulted principally from costs incurred
in
research and development, including clinical trials, and from general and
administrative costs associated with our operations. While we seek to attain
profitability, we cannot be sure that we will ever achieve product and other
revenue sufficient for us to attain this objective.
With
the
exception of Generex Oral-lyn™ which is currently available for sale in Ecuador
and has been approved for sale in India and our over-the-counter glucose and
energy spray products, Glucose RapidSpray™, BaBOOM!™ Energy Spray and
GlucoBreak™, our product candidates are in research or early stages of
pre-clinical and clinical development. We will need to conduct substantial
additional research, development and clinical trials. We will also need to
receive necessary regulatory clearances both in the United States and foreign
countries and obtain meaningful patent protection for and establish freedom
to
commercialize each of our product candidates. We must also complete further
clinical trials and seek regulatory approvals for Generex Oral-lyn™ in countries
outside of Ecuador and India. We cannot be sure that we will obtain required
regulatory approvals, or successfully research, develop, commercialize,
manufacture and market any other product candidates. We expect that these
activities, together with future general and administrative activities, will
result in significant expenses for the foreseeable future.
Risks
Related to Our Technologies
With
the exception of Generex Oral-lyn™, Glucose RapidSpray™, BaBOOM! ™ Energy Spray
and GlucoBreak™, our technologies and products are at an early stage of
development and we cannot expect revenues in respect thereof in the foreseeable
future.
We
have
no products approved for commercial sale at the present time with the exception
of Generex Oral-lyn™ which is available only in Ecuador and has recently been
approved for commercial sale in India and our glucose sprays which are available
over-the-counter in retail outlets in the United States and Canada. To be
profitable, we must not only successfully research, develop and obtain
regulatory approval for our products under development, but also manufacture,
introduce, market and distribute them once development is completed. We may
not
be successful in one or more of these stages of the development or
commercialization of our products, and/or any of the products we develop may
not
be commercially viable.
21
Although
Generex Oral-lyn™, our proprietary oral insulin spray formulation, has been
approved for commercial marketing and sale in Ecuador and India, and our glucose
spray products are available for purchase in the United States and Canada,
we
have yet to manufacture, market and distribute these products on a large-scale
commercial basis. We expect to receive nominal revenues from sales of these
products in fiscal year 2008. Until we can establish that they are commercially
viable products, we will not receive significant revenues from ongoing
operations.
Until
we receive regulatory approval to sell our pharmaceutical products in additional
countries, our ability to generate revenues from operations may be limited
and
those revenues may be insufficient to sustain operations. Many factors impact
our ability to obtain approvals for commercially viable
products.
Our
only
pharmaceutical product that has been approved for commercial sale by drug
regulatory authorities is our oral insulin spray formulation, and that approval
has been obtained in Ecuador and, recently, in India. We have begun the
regulatory approval process for our oral insulin, buccal morphine and fentanyl
products in other countries, and we expect to begin late stage clinical trials
of Generex Oral-lyn™ at some of our clinical trial sites according to the Phase
III clinical plan in early 2008.
Our
immunomedicine products are in the pre-clinical stage of development, with
the
exception of a Phase II trial in human patients with stage II HER-2/neu positive
breast cancer, a Phase I trial in human volunteers of a peptide vaccine for
use
against the H5N1 avian influenza virus and Phase I trial of our experimental
H5N1 prophylactic vaccine in Beirut, Lebanon.
Pre-clinical
and clinical trials of our products, and the manufacturing and marketing of
our
technologies, are subject to extensive, costly and rigorous regulation by
governmental authorities in the United States, Canada and other countries.
The
process of obtaining required regulatory approvals from the FDA and other
regulatory authorities often takes many years, is expensive and can vary
significantly based on the type, complexity and novelty of the product
candidates. For these reasons, it is possible we will not receive regulatory
approval for any prescription pharmaceutical product candidate in any country
other than Ecuador and India.
In
addition, we cannot be sure when or if we will be permitted by regulatory
agencies to undertake additional clinical trials or to commence any particular
phase of clinical trials. Because of this, statements in this Quarterly Report
regarding the expected timing of clinical trials cannot be regarded as actual
predictions of when we will obtain regulatory approval for any "phase" of
clinical trials.
Delays
in
obtaining United States or other foreign approvals for our pharmaceutical
products could result in substantial additional costs to us, and, therefore,
could adversely affect our ability to compete with other companies. If
regulatory approval is ultimately granted in any country other than Ecuador
and
India, the approval may place limitations on the intended use of the product
we
wish to commercialize, and may restrict the way in which we are permitted to
market the product.
Risks
Related to Marketing of Our Potential Products
We
may not be able to compete with treatments now being marketed and developed,
or
which may be developed and marketed in the future by other
companies.
Our
products will compete with existing and new therapies and treatments. We are
aware of a number of companies currently seeking to develop alternative means
of
delivering insulin, as well as new drugs intended to replace insulin therapy
at
least in part. We are also aware of a number of companies currently seeking
to
develop alternative means of enhancing and suppressing peptides. In the longer
term, we also face competition from companies that seek to develop cures for
diabetes and other malignant, infectious, autoimmune and allergic diseases
through techniques for correcting the genetic deficiencies that underlie such
diseases.
Numerous
pharmaceutical, biotechnology and drug delivery companies, hospitals, research
organizations, individual scientists and nonprofit organizations are engaged
in
the development of alternatives to our technologies. Some of these companies
have greater research and development capabilities, experience, manufacturing,
marketing, financial and managerial resources than we do. Collaborations or
mergers between large pharmaceutical or biotechnology companies with competing
drug delivery technologies could enhance our competitors’ financial, marketing
and other resources. Developments by other drug delivery companies could make
our products or technologies uncompetitive or obsolete. Accordingly, our
competitors may succeed in developing competing technologies, obtaining FDA
approval for products or gaining market acceptance more rapidly than we can.
22
One
of
our most significant competitors, Pfizer, announced in mid-October that it
would
no longer sell or produce its inhalable form of insulin, marketed as Exubera®,
due to disappointing sales and failure to gain traction with patients and
physicians. Pfizer also announced that it would discontinue development of
a
next generation inhaled insulin device. We believe that our buccal delivery
technology offers several advantages over inhaled insulin, including: the
avoidance of pulmonary inhalation, which requires frequent physician monitoring,
ease of use and portability.
Other
direct competitors have development programs underway for inhaled insulin
products, which, if approved, could compete against Generex Oral-lyn™. These
companies include Novo Nordisk, Eli Lilly Company /Alkermes, Inc, MannKind
Corporation, Bentley Pharmaceuticals, Inc. and Abbott Laboratories through
its
acquisition of Kos Pharmaceuticals, all of which are working on various versions
of inhaled insulin products in either a liquid or a dry form. Some products
are
in late stage clinical testing including Alkermes’s inhalable insulin product
(AIR Insulin System™) in Phase III clinical development and Mannkind’s
Technosphere® Insulin System also in Phase III clinical development. Other
smaller companies, including Emisphere Technologies, Inc., are in various stages
of developing oral or buccal insulin formulations.
Item.
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
Unregistered
Sales of Equity Securities
In
the
fiscal quarter ended October 31, 2007, we sold common stock and other securities
in transactions in reliance upon exemptions from the registration requirements
of the Securities Act.
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, 2008.
During the three months ended October 31, 2007, we issued 50,000 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.
During
the three months ended October 31, 2007, we issued 16,000 shares of common
stock
to American Capital Ventures, Inc. pursuant to an agreement with us for
financial services. The sale of such shares was exempt from registration under
the Securities Act in reliance upon Section 4(2) thereof. We believe that
American Capital Ventures, 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.
During
the three months ended October 31, 2007, we issued 68,184 shares of common
stock
to Lyons Capital LLC. pursuant to an agreement with us for financial services.
The sale of such shares was exempt from registration under the Securities Act
in
reliance upon Section 4(2) thereof. We believe that Lyons Capital LLC. 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.
During
the three months ended October 31, 2007, we have issued 37,500 shares of our
restricted common stock as partial consideration for the provision of services
by The
Abajian Group, LLC
under an
agreement with us. The sale of such shares was exempt from registration under
the Securities Act in reliance upon Section 4(2) thereof. We believe that The
Abajian Group, LLC. 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 October 31, 2007.
23
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.
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)
|
|
Amended
and Restated Bylaws of Generex Biotechnology Corporation (incorporated
by
reference to Exhibit 3(ii) to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2007)
|
|
|
|
4.1
|
|
Form
of Common Stock Certificate (incorporated by reference to Exhibit
4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
|
|
|
4.2.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|
|
|
4.2.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|
|
|
4.2.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|
|
|
4.3
|
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to
Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|
|
|
4.4.1
|
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
24
4.4.2
|
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.3
|
|
Form
of Warrant issued in connection with Exhibit 4.4.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
4.4.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.4.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
|
|
4.5.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.3
|
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.5.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
25
4.8.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.3
|
|
Warrant
issued in connection with Exhibit 4.9.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.9.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.10.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.10.3
|
|
Form
of Warrant issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.10.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.11.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
4.11.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.4
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
26
4.12
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|
|
|
4.13.1
|
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
|
|
|
4.13.2
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
|
|
|
4.14
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|
|
|
4.15.1
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.2
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.3
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.4
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
|
|
4.15.5
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.16.1
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.2
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.3
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.4
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
4.16.5
|
|
Form
of Additional AIR Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
27
4.16.6
|
|
Form
of Additional AIR Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.17.1
|
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
|
|
|
4.17.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
|
|
|
|
4.18
|
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006)
|
|
|
|
4.19
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
|
|
|
4.20.1
|
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
|
|
|
|
4.20.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
|
|
|
|
4.21.1
|
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
|
|
|
4.21.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.39 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
|
|
|
9
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
10.1
|
|
Form
of Restricted Stock Agreement for awards to executive officers of
Generex
Biotechnology Corporation under the Generex Biotechnology Corporation
2006
Stock Plan (incorporated by reference to Exhibit 10.1 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)
|
|
|
|
10.2
|
|
Summary
of Annual Base Salaries of Executive Officers of Generex Biotechnology
Corporation (incorporated by reference to Exhibit 10.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)
|
10.3
|
|
Summary
of Compensation of the Directors of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 10.27 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 15,
2007)
|
|
|
|
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.
|
|
28
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:
December 07, 2007
|
By: |
/s/ Anna
E. Gluskin
|
Anna
E. Gluskin
|
||
President
and Chief Executive Officer
|
Date:
December 07, 2007
|
By: |
/s/ Rose
C. Perri
|
Rose
C. Perri
|
||
Chief
Financial Officer
|
Generex
Biotechnology Corporation
Form
10-Q
October
31, 2007
Exhibit
Index
Exhibit
Number
|
|
Description
of Exhibit(1)
|
|
|
|
2
|
|
Agreement
and Plan of Merger among Generex Biotechnology Corporation, Antigen
Express, Inc. and AGEXP Acquisition Inc. (incorporated by reference
to
Exhibit 2.1 to Generex Biotechnology Corporation’s Current Report on Form
8-K filed on August 15, 2003)
|
|
|
|
3(i)
|
|
Restated
Certificate of Incorporation of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 3(II) to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on June 19,
2006)
|
|
|
|
3(ii)
|
|
Amended
and Restated Bylaws of Generex Biotechnology Corporation (incorporated
by
reference to Exhibit 3(ii) to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2007)
|
|
|
|
4.1
|
|
Form
of Common Stock Certificate (incorporated by reference to Exhibit
4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
|
|
|
4.2.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
29
4.2.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|
|
|
4.2.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|
|
|
4.3
|
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to
Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|
|
|
4.4.1
|
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.2
|
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.3
|
|
Form
of Warrant issued in connection with Exhibit 4.4.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
4.4.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.4.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
|
|
4.5.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.3
|
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.5.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
30
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
4.8.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.3
|
|
Warrant
issued in connection with Exhibit 4.9.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.9.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.10.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
31
4.10.3
|
|
Form
of Warrant issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.10.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.11.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
4.11.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.4
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
4.12
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|
|
|
4.13.1
|
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
|
|
|
4.13.2
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
|
|
|
4.14
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|
|
|
4.15.1
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.2
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.3
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.4
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
|
|
4.15.5
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006)
|
32
4.16.1
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.2
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
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4.16.3
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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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4.16.4
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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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4.16.5
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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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4.16.6
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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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4.17.1
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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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4.17.2
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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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4.18
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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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4.19
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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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4.20.1
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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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4.20.2
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Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
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4.21.1
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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)
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4.21.2
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Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.39 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
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33
9
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Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
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10.1
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Form
of Restricted Stock Agreement for awards to executive officers of
Generex
Biotechnology Corporation under the Generex Biotechnology Corporation
2006
Stock Plan (incorporated by reference to Exhibit 10.1 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)
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10.2
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Summary
of Annual Base Salaries of Executive Officers of Generex Biotechnology
Corporation (incorporated by reference to Exhibit 10.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)
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10.3
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Summary
of Compensation of the Directors of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 10.27 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 15,
2007)
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31.1
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Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
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31.2
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Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
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32
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Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002
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(1)
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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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34