GENEREX BIOTECHNOLOGY CORP - Quarter Report: 2008 January (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT OF 1934
For
the
quarterly period ended January 31, 2008
o
TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934
For
the transition period from_________________ to
________________
COMMISSION
FILE NUMBER: 0-25169
GENEREX
BIOTECHNOLOGY CORPORATION
(Exact name of registrant as specified in its charter)
|
Delaware
|
|
98-0178636
|
|
|
(State
of other jurisdiction of incorporation or
organization)
|
|
(IRS
Employer Identification No.)
|
|
33
HARBOUR SQUARE, SUITE 202
TORONTO,
ONTARIO
CANADA
M5J 2G2
(Address
of principal executive offices)
416/364-2551
(Registrant's telephone number, including area code)
Not
applicable
(Former name, former address and former fiscal year
if
changed since last report)
Indicate
by check mark whether the registrant: (1) has filed all reports required by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for the
past
90 days. xYes oNo
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
definition of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer ¨
|
Accelerated
filer x
|
Non-accelerated
filer ¨
|
Smaller
reporting company ¨
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
o
Yes
x
No
The
number of outstanding shares of the registrant's common stock, par value $.001,
was 111,478,091 as of March 6, 2008.
GENEREX
BIOTECHNOLOGY CORPORATION
INDEX
PART
I. FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1. Financial
Statements.
|
||
|
|
|
(Unaudited)
|
|
|
Consolidated
Balance Sheets -
|
|
|
January
31, 2008 and July 31, 2007
|
1
|
|
|
|
|
Consolidated
Statements of Operations -- for the three and six month
|
|
|
periods
ended January 31, 2008 and 2007, and cumulative from
|
|
|
November
2, 1995 to January 31, 2008
|
2
|
|
|
|
|
Consolidated
Statements of Cash Flows -- For the six month
|
|
|
periods
ended January 31, 2008 and 2007, and cumulative from
|
|
|
November
2, 1995 to January 31, 2008
|
3
|
|
|
|
|
Notes
to Consolidated Financial Statements
|
5
|
|
|
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
12
|
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
22
|
|
||
Item
4.
|
Controls
and Procedures
|
23
|
|
||
PART
II: OTHER INFORMATION
|
||
|
||
Item
1.
|
Legal
Proceedings
|
23
|
Item
1A.
|
Risk
Factors
|
24
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
25
|
|
||
Item
3.
|
Defaults
Upon Senior Securities
|
26
|
|
||
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
26
|
|
||
Item
5.
|
Other
Information
|
26
|
|
|
|
Item
6.
|
Exhibits
|
27
|
|
||
Signatures
|
32
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
GENEREX
BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIES
|
||||||||||
(A
DEVELOPMENT STAGE COMPANY)
|
||||||||||
CONSOLIDATED
BALANCE SHEETS
|
||||||||||
|
(UNAUDITED)
|
||||||||||
January
31,
|
July
31,
|
|||||||||
2008
|
2007
|
|||||||||
ASSETS
|
||||||||||
Current
Assets:
|
||||||||||
Cash
and cash equivalents
|
$
|
2,519,987
|
$
|
21,026,067
|
||||||
Short-term
investments
|
20,182,969
|
14,011,738
|
||||||||
Accounts
receivable
|
102,927
|
58,264
|
||||||||
Inventory
|
382,512
|
123,931
|
||||||||
Other
current assets
|
442,432
|
469,210
|
||||||||
Total
Current Assets
|
23,630,827
|
35,689,210
|
||||||||
Property
and Equipment, Net
|
1,927,229
|
2,137,027
|
||||||||
Assets
Held for Investment, Net
|
3,882,590
|
3,693,183
|
||||||||
Patents,
Net
|
4,804,795
|
4,884,984
|
||||||||
TOTAL
ASSETS
|
$
|
34,245,441
|
$
|
46,404,404
|
||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||||
Current
Liabilities:
|
||||||||||
Accounts
payable and accrued expenses
|
$
|
5,801,032
|
$
|
7,156,709
|
||||||
Deferred
revenue and rebate liability
|
103,199
|
33,314
|
||||||||
Current
maturities of long-term debt
|
704,822
|
84,503
|
||||||||
Total
Current Liabilities
|
6,609,053
|
7,274,526
|
||||||||
Long-Term
Debt, Net
|
2,614,450
|
3,059,286
|
||||||||
Commitments
and Contingencies
|
||||||||||
Stockholders’
Equity:
|
||||||||||
Special
Voting Rights Preferred Stock, $.001 par value; authorized
|
||||||||||
1,000
shares at January 31, 2008 and July 31, 2007; -0- shares
|
||||||||||
issued
and outstanding at January 31, 2008 and July 31, 2007
|
--
|
--
|
||||||||
Common
stock, $.001 par value; authorized 500,000,000 shares at
|
||||||||||
January
31, 2008 and July 31, 2007; 111,453,633 and 109,616,518 shares
issued
and outstanding at January 31, 2008 and July 31, 2007,
respectively
|
111,453
|
109,616
|
||||||||
Additional
paid-in capital
|
249,656,127
|
247,079,439
|
||||||||
Deficit
accumulated during the development stage
|
(225,729,357
|
)
|
(212,000,270
|
)
|
||||||
Accumulated
other comprehensive income
|
983,715
|
881,807
|
||||||||
Total
Stockholders’ Equity
|
25,021,938
|
36,070,592
|
||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
34,245,441
|
$
|
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
|
||||||||||||||||||||||
(UNAUDITED)
|
Cumulative
From
|
||||||||||||||||
November
2, 1995
|
||||||||||||||||
For
the Six Months Ended
|
For
the Three Months Ended
|
(Date
of Inception)
|
||||||||||||||
January
31,
|
January
31,
|
to
January 31,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
2008
|
||||||||||||
Revenues
|
$
|
65,331
|
$
|
184,928
|
$
|
18,904
|
$
|
45,923
|
$
|
2,442,056
|
||||||
Sales
discounts
|
(1,991
|
)
|
(502
|
)
|
(277
|
)
|
(502
|
)
|
(4,222
|
)
|
||||||
Net
Revenue
|
63,340
|
184,426
|
18,627
|
45,421
|
2,437,834
|
|||||||||||
Cost
of Goods Sold
|
25,585
|
52,981
|
5,654
|
21,466
|
87,208
|
|||||||||||
Operating
Expenses:
|
||||||||||||||||
Research
and development
|
7,317,427
|
4,075,015
|
3,469,624
|
2,482,082
|
80,773,891
|
|||||||||||
Research
and development -
|
||||||||||||||||
related
party
|
--
|
--
|
--
|
--
|
220,218
|
|||||||||||
Selling
and marketing
|
651,918
|
13,399
|
284,498
|
13,399
|
1,401,255
|
|||||||||||
General
and administrative
|
6,602,793
|
5,501,690
|
3,086,873
|
3,006,951
|
96,642,211
|
|||||||||||
General
and administrative -
|
||||||||||||||||
related
party
|
--
|
--
|
--
|
--
|
314,328
|
|||||||||||
Total
Operating Expenses
|
14,572,138
|
9,590,104
|
6,840,995
|
5,502,432
|
179,351,903
|
|||||||||||
Operating
Loss
|
(14,534,383
|
)
|
(9,458,659
|
)
|
(6,828,022
|
)
|
(5,478,477
|
)
|
(177,001,277
|
)
|
||||||
Other
Income (Expense):
|
||||||||||||||||
Miscellaneous
income (expense)
|
--
|
--
|
--
|
--
|
196,193
|
|||||||||||
Income
from Rental Operations, net
|
170,411
|
147,806
|
88,324
|
79,189
|
1,091,339
|
|||||||||||
Interest
income
|
751,507
|
1,204,897
|
291,472
|
601,125
|
7,093,965
|
|||||||||||
Interest
expense
|
(116,622
|
)
|
(566,898
|
)
|
(58,948
|
)
|
(275,164
|
)
|
(43,718,637
|
)
|
||||||
Loss
on extinguishment of debt
|
--
|
(180,825
|
)
|
--
|
(122,307
|
)
|
(14,134,068
|
)
|
||||||||
Net
Loss Before Undernoted
|
(13,729,087
|
)
|
(8,853,679
|
)
|
(6,507,174
|
)
|
(5,195,634
|
)
|
(226,472,485
|
)
|
||||||
Minority
Interest Share of Loss
|
--
|
--
|
--
|
--
|
3,038,185
|
|||||||||||
Net
Loss
|
(13,729,087
|
)
|
(8,853,679
|
)
|
(6,507,174
|
)
|
(5,195,634
|
)
|
(223,434,300
|
)
|
||||||
Preferred
Stock Dividend
|
--
|
--
|
--
|
--
|
2,295,057
|
|||||||||||
Net
Loss Available to Common
|
||||||||||||||||
Shareholders
|
$
|
(13,729,087
|
)
|
$
|
(8,853,679
|
)
|
$
|
(6,507,174
|
)
|
$
|
(5,195,634
|
)
|
$
|
(225,729,357
|
)
|
|
Basic
and Diluted Net Loss Per
|
||||||||||||||||
Common
Share
|
$
|
(.12
|
)
|
$
|
(.08
|
)
|
$
|
(.06
|
)
|
$
|
(.05
|
)
|
||||
Weighted
Average Number of Shares
|
||||||||||||||||
of
Common Stock Outstanding
|
110,502,721
|
107,884,535
|
110,945,413
|
108,160,528
|
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
|
|||||||||||||
(UNAUDITED)
|
Cumulative
From
|
||||||||||
November
2, 1995
|
||||||||||
For
the Six Months Ended
|
(Date
of Inception)
|
|||||||||
January
31,
|
to
January 31,
|
|||||||||
2008
|
2007
|
2008
|
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
$
|
(13,729,087
|
)
|
$
|
(8,853,679
|
)
|
$
|
(223,434,300
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
||||||||||
in
operating activities:
|
||||||||||
Depreciation
and amortization
|
599,644
|
577,206
|
6,481,590
|
|||||||
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
|
--
|
180,826
|
14,134,069
|
|||||||
Common
stock issued as employee compensation
|
1,002,699
|
183,000
|
3,296,279
|
|||||||
Common
stock issued for services rendered
|
1,054,661
|
354,389
|
8,050,977
|
|||||||
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
|
--
|
435,087
|
18,930,427
|
|||||||
Common
stock issued as interest payment on convertible
|
||||||||||
debentures
|
--
|
15,716
|
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
|
(51,281
|
)
|
(110,104
|
)
|
(107,961
|
)
|
||||
Miscellaneous
receivables
|
--
|
--
|
43,812
|
|||||||
Inventory
|
(247,815
|
)
|
(44,087
|
)
|
(365,317
|
)
|
||||
Other
current assets
|
16,200
|
(177,291
|
)
|
(112,513
|
)
|
|||||
Accounts
payable and accrued expenses
|
(922,649
|
)
|
(341,258
|
)
|
10,405,466
|
|||||
Deferred
revenue
|
69,384
|
15,475
|
102,415
|
|||||||
Other,
net
|
--
|
--
|
110,317
|
|||||||
Net
Cash Used in Operating Activities
|
(12,208,244
|
)
|
(7,761,623
|
)
|
(130,096,521
|
)
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
3
Cumulative
From
|
||||||||||
November
2, 1995
|
||||||||||
For
the Six Months Ended
|
(Date
of Inception)
|
|||||||||
January
31,
|
to
January 31,
|
|||||||||
2008
|
2007
|
2008
|
Cash
Flows From Investing Activities:
|
||||||||||
Purchase
of property and equipment
|
(2,499
|
)
|
(77,208
|
)
|
(4,538,910
|
)
|
||||
Costs
incurred for patents
|
(118,277
|
)
|
(105,302
|
)
|
(1,935,879
|
)
|
||||
Change
in restricted cash
|
--
|
--
|
45,872
|
|||||||
Proceeds
from maturity of short term investments
|
11,829,420
|
17,488,782
|
169,912,229
|
|||||||
Purchases
of short-term investments
|
(18,000,651
|
)
|
(11,413,110
|
)
|
(190,095,198
|
)
|
||||
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
|
30,795
|
(176,092
|
)
|
(672,495
|
)
|
|||||
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
|
(6,261,212
|
)
|
5,717,070
|
(30,584,116
|
)
|
|||||
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
|
(44,056
|
)
|
(34,773
|
)
|
(1,896,425
|
)
|
||||
Change
in due to related parties
|
--
|
--
|
154,541
|
|||||||
Proceeds
from exercise of warrants
|
--
|
125,000
|
44,015,049
|
|||||||
Proceeds
from exercise of stock options
|
49,290
|
176,983
|
4,603,416
|
|||||||
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
|
--
|
(76,923
|
)
|
(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
|
5,234
|
190,287
|
163,213,042
|
|||||||
Effect
of Exchange Rates on Cash
|
(41,858
|
)
|
(13,025
|
)
|
(12,418
|
)
|
||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(18,506,080
|
)
|
(1,867,291
|
)
|
2,519,987
|
|||||
Cash
and Cash Equivalents, Beginning of Period
|
21,026,067
|
38,208,493
|
--
|
|||||||
Cash
and Cash Equivalents, End of Period
|
$
|
2,519,987
|
$
|
36,341,202
|
$
|
2,519,987
|
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 six- and three-month periods 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 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
January 31, 2008.
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 February 12, 2008,
the
FASB delayed the effective date for non-financial assets and liabilities
to
fiscal years beginning after November 15, 2008; 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.
In
February 2007, the FASB issued SFAS No. 159, “Establishing the Fair Value Option
for Financial Assets and Liabilities” (“SFAS 159”) 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 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 157.
The
Company is currently evaluating this pronouncement in connection with SFAS
157.
In
December 2007, the FASB issued SFAS No. 141(R), “Business Combinations”
(“SFAS 141(R)”). This Statement replaces SFAS No. 141, “Business
Combinations” (“SFAS 141”). This Statement retains the fundamental requirements
in SFAS 141 that the acquisition method of accounting (which SFAS 141 called
the
purchase method) be used for all business combinations and for an acquirer
to be
identified for each business combination. This Statement also establishes
principles and requirements for how the acquirer: a) recognizes and measures
in
its financial statements the identifiable assets acquired, the liabilities
assumed, and any non-controlling interest in the acquiree; b) recognizes
and
measures the goodwill acquired in the business combination or a gain from
a
bargain purchase and c) determines what information to disclose to enable
users
of the financial statements to evaluate the nature and financial effects
of the
business combination. SFAS 141(R) will apply prospectively to business
combinations for which the acquisition date is on or after the beginning
of the
first annual reporting period beginning on or after December 15, 2008. An
entity
may not apply it before that date. The Company is currently evaluating the
impact of this statement on its results of operations or financial
position.
6
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements” (“SFAS 160”). This Statement amends ARB 51 to
establish accounting and reporting standards for the non-controlling (minority)
interest in a subsidiary and for the deconsolidation of a subsidiary. It
clarifies that a non-controlling interest in a subsidiary is an ownership
interest in the consolidated entity that should be reported as equity in
the
consolidated financial statements. SFAS 160 is effective for fiscal years,
and
interim periods within those fiscal years, beginning on or after December
15,
2008. Earlier adoption is prohibited. The Company is currently evaluating
the impact of this statement on its results of operations or financial
position.
4. |
Stock-Based
Compensation
|
As
of
January 31, 2008, 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 January 31, 2008, there were 2,000,000, 2,643,490 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 (collectively, the “Plans”) are administered by the Board of
Directors (the “Board”). The Board is authorized to select from among eligible
employees, directors, advisors and consultants those individuals to whom
options
are to be granted and to determine the number of shares to be subject to,
and
the terms and conditions of the options. The Board is also authorized to
prescribe, amend and rescind terms relating to options granted under the
Plans.
Generally, the interpretation and construction of any provision of the Plans
or
any options granted hereunder is within the discretion of the
Board.
The
Plans
provide that options may or may not be Incentive Stock Options (“ISOs”) within
the meaning of Section 422 of the Internal Revenue Code. Only employees of
the
Company are eligible to receive ISOs, while employees and non-employee
directors, advisors and consultants are eligible to receive options which
are
not ISOs, i.e. “Non-Qualified Options.” The options granted by the Board in
connection with its adoption of the Plans are Non-Qualified Options. In
addition, the 2006 Plan also provides for restricted stock grants.
The
following information relates to stock options that have been granted under
the
Company’s stockholder-approved incentive plans. The stock option exercise price
is typically granted at 100 percent of the fair market value on the date
the
options are granted. Options may be exercised for a period of five years
commencing on the date of grant and 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 the 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 six months ended January 31,
2008.
7
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
summary of the stock option activity for the six months ended January 31,
2008
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
|
(1,490,000
|
)
|
$
|
2.10
|
|||||||||
Exercised
|
(31,000
|
)
|
$
|
1.59
|
|||||||||
Outstanding,
January 31, 2008
|
6,441,638
|
$
|
0.67
|
1.70
|
$
|
4,670,131
|
|||||||
Exercisable,
January 31, 2008
|
6,441,638
|
$
|
0.67
|
1.70
|
$
|
4,670,131
|
|||||||
Grant
Date Fair Value of Forfeited or Expired Options
|
$
|
1.56
|
|||||||||||
Total
Intrinsic Value of Options Exercised
|
$
|
7,750
|
As of January 31, 2008, 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.
During
the six month ended January 31, 2008, 396,000 shares of restricted and 150,000
shares of unrestricted common stock were granted to employees, consultants
and
advisors under the 2006 Plan fair valued at $828,920 and has been included
in
the statement of operations (see Note 10). These shares were fully vested
on the
date of grant.
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 January 31, 2008:
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, January 31, 2008
|
237,500
|
$
|
1.51
|
As
of
January 31, 2008, approximately $235,000 of total unrecognized compensation
costs related to unvested shares is expected to be recognized over the remaining
service period of 1.75 years.
8
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
5. |
Comprehensive
Income/(Loss)
|
Comprehensive
loss, which includes net loss and the change in the foreign currency translation
account during the period, for the six months ended January 31, 2008 and
2007,
was $13,627,179 and $8,952,888, respectively, and for the three months ended
January 31, 2008 and 2007, was $6,639,645 and $5,312,527,
respectively.
6. |
Accounts
Payable and Accrued Expenses
|
Accounts
payable and accrued expenses consist of the following:
January
31,
|
July
31,
|
||||||
2008
|
2007
|
||||||
Accounts
Payable
|
$
|
2,770,624
|
$
|
1,791,080
|
|||
Research
and Development
|
1,377,932
|
1,956,049
|
|||||
Executive
Compensation
|
1,523,124
|
2,252,978
|
|||||
Financial
Services
|
129,352
|
1,156,602
|
|||||
Total
|
$
|
5,801,032
|
$
|
7,156,709
|
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.
9
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
8. |
Net
Loss Per Share
|
Basic
EPS
and Diluted EPS for the six and three months ended January 31, 2008 and 2007
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
20,758,296 incremental shares, at January 31, 2008 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 23,647,730 incremental shares, at January 31, 2007 have been
excluded from the computation of Diluted EPS as they are
anti-dilutive.
9. |
Supplemental
Disclosure of Cash Flow
Information
|
For
the Six Months Ended
|
|||||||
January
31,
|
|||||||
2008
|
2007
|
||||||
Cash
paid during the period for:
|
|||||||
Interest
|
$
|
116,666
|
$
|
137,696
|
|||
Income
taxes
|
$
|
--
|
$
|
--
|
|||
Disclosure
of non-cash investing and financing activities:
|
|||||||
Issuance
of common stock as satisfaction of accrued
|
|||||||
executive
compensation
|
$
|
471,875
|
$
|
--
|
|||
Principal
repayment of convertible debentures through the
|
|||||||
of
common stock
|
$
|
--
|
$
|
384,616
|
|||
Issuance
of common stock in conjunction with convertible
|
|||||||
debenture
conversion
|
$
|
--
|
$
|
52,554
|
10. |
Stockholders’
Equity
|
During
the six months ended January 31, 2008, the Company issued 677,623 shares
of
common stock to various consultants for services rendered in the amount of
$1,054,661. The shares were valued at $1.34 to $1.84 per share based on the
quoted market price of the Company’s common stock on the dates of the
issuances.
During
the six months ended January 31, 2008, the Company issued 578,492 shares
of
common stock valued at $879,421 as employee compensation including 546,000
shares issued under 2006 Stock Option Plan (see Note 4). The shares were
valued
at $1.36 to $1.75 per share based on the quoted market price of the Company’s
common stock on the dates of the issuances.
During
the six months ended January 31, 2008, 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).
During
the six months ended January 31, 2008, the Company received aggregate cash
proceeds of $49,290 from exercises of stock options. The Company issued 31,000
shares of common stock as a result of these transactions.
10
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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
|
677,623
|
$
|
678
|
$
|
1,053,983
|
$
|
1,054,661
|
||||||
Issuance
as employee compensation
|
578,492
|
578
|
878,843
|
879,421
|
|||||||||
Issuance
as executive compensation
|
550,000
|
550
|
(550
|
)
|
--
|
||||||||
Stock-based
executive compensation
|
--
|
--
|
123,276
|
123,276
|
|||||||||
Issuance
in satisfaction of accrued
|
|||||||||||||
executive
compensation
|
--
|
--
|
471,875
|
471,875
|
|||||||||
Stocks
options exercised for cash
|
31,000
|
31
|
49,259
|
49,290
|
|||||||||
Total
|
1,837,115
|
$
|
1,837
|
$
|
2,576,686
|
$
|
2,578,523
|
11. |
Subsequent
Events
|
In
February, 2008, a securities broker-dealer and investment bank filed a complaint
against the Company in the Supreme Court of the State of New York alleging
breach of a business advisory agreement and seeking cash, stock, and warrant
compensation. The Company has not yet filed an answer to the complaint; we
are 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.
11
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
As
used
herein, the terms the “Company,” “Generex,” “we,” “us,” or “our” refer to
Generex Biotechnology Corporation, a Delaware corporation. The following
discussion and analysis by management provides information with respect to
our
financial condition and results of operations for the three- and six-month
periods ended January 31, 2008. This discussion should be read in
conjunction with the information contained in Part
I, Item 1A - Risk Factors
and
Part
II, Item 8 - Financial Statements and Supplementary Data
in our
Annual Report on Form 10-K for the year ended July 31, 2007, as amended, and
the
information contained in Part
I, Item 1 - Financial Statements
and
Part
II, Item 1A- Risk Factors in
this
Quarterly Report on Form 10-Q for the fiscal quarter ended January 31,
2008.
Forward-Looking
Statements
We
have
made statements in this Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
and
elsewhere in this Quarterly Report on Form 10-Q of Generex Biotechnology
Corporation for the fiscal quarter ended January 31, 2008 that may constitute
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 (the "Act"). The Act limits our liability in
any
lawsuit based on forward-looking statements that we have made. All statements,
other than statements of historical facts, included in this Quarterly Report
that address activities, events or developments that we expect or anticipate
will or may occur in the future, including such matters as our projections,
future capital expenditures, business strategy, competitive strengths, goals,
expansion, market and industry developments and the growth of our businesses
and
operations, are forward-looking statements. These statements can be identified
by introductory words such as "expects," "plans," "intends," "believes," "will,"
"estimates," “anticipates,” "projects," “predicts,” “foresees” or words of
similar meaning, and by the fact that they do not relate strictly to historical
or current facts. Our forward-looking statements address, among other
things:
|
Ÿ
|
our
expectations concerning product candidates for our
technologies;
|
|
Ÿ
|
our
expectations concerning existing or potential development and license
agreements for third-party collaborations and joint
ventures;
|
|
Ÿ
|
our
expectations of when different phases of clinical activity may commence
and conclude;
|
|
Ÿ
|
our
expectations of when regulatory submissions may be filed or when
regulatory approvals may be received; and
|
|
Ÿ
|
our
expectations of when commercial sales of our products may commence
and
when actual revenue from the product sales may be
received.
|
Any
or
all of our forward-looking statements may turn out to be wrong. They may be
affected by inaccurate assumptions that we might make or by known or unknown
risks and uncertainties. Actual outcomes and results may differ materially
from
what is expressed or implied in our forward-looking statements. Among the
factors that could affect future results are:
|
Ÿ
|
the
inherent uncertainties of product development based on our new and
as yet
not fully proven technologies;
|
|
Ÿ
|
the
risks and uncertainties regarding the actual effect on humans of
seemingly
safe and efficacious formulations and treatments when tested
clinically;
|
|
Ÿ
|
the
inherent uncertainties associated with clinical trials of product
candidates;
|
|
Ÿ
|
the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product candidates;
|
|
Ÿ
|
the
inherent uncertainties associated with commercialization of products
that
have received regulatory approval; and
|
|
Ÿ
|
our
ability to obtain the necessary financing to fund our
operations.
|
Additional
factors that could affect future results are set forth in Part
I, Item 1A Risk Factors
of our
Annual Report on Form 10-K for the year ended July 31, 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.
12
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
six-month period ending January 31, 2008, we received approximately $63,340
in
revenues from sales of Glucose RapidSpray™. This number does not reflect
deferred sales to the customers during this period with the right of
return.
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, Europe and
certain countries in Eastern Europe including Russia, Ukraine, Bulgaria and
Romania and assisting our Indian licensee with preparation for the
commercialization of Generex Oral-lyn™ in 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 has begun at some of the sites with the
first dosing taking place in April 2008 and is expected 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).
13
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 the second calendar quarter of 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 later in 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.
Pursuant
to a licensing and distribution agreement with a multinational distributor,
we
have submitted applications for registration of Generex Oral-lyn™ to some of the
public health authorities in the Middle East, but no approvals have been
forthcoming to date except for a limited, pharmacy specific importation license
in the United Arab Emirates to import Generex Oral-lyn™ into Abu Dhabi. We
terminated the licensing and distribution agreement with the Armenian
Development Agency (the “ADA”) and Canada Armenia Trading House Ltd. (“CATH”)
relating to the regulatory approval and commercialization of Generex Oral-lyn™
in Armenia, Georgia, and Kazakhstan as of January 16, 2008, but we are
continuing to prosecute the registration submitted to public health authorities
in Armenia.
We
face
competition from other providers of alternate forms of insulin. One of our
most
significant competitors, Pfizer, announced in October 2007 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 implemented 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. In December 2007, we received a $400,000 purchase
order for our over-the-counter products, including Glucose Rapid Spray™, from
Leosons General Trading Company. We are currently in the process of filing
the
order.
14
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, which we anticipate to be a prospective
companion product for Generex Oral-lyn™. Fertin Pharma is in the process of
producing clinical materials for a bioequivalence Phase I study which is
expected to commence before the end of calendar year 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. The Phase II
clinical trial of the Antigen peptide vaccine in breast cancer patient commenced
patient dosing in May 2007. 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. Patient dosing
for Phase I clinical trials with the same compound as an immunotherapeutic
vaccine for prostate cancer is currently underway at two hospital sites in
Athens, Greece.
The
Lebanese-Canadian Hospital in Beirut, Lebanon commenced a Phase I clinical
trial
of the Antigen synthetic avian influenza vaccine in April 2007 that is currently
ongoing. In addition, Antigen entered into an agreement with Drs. Daopei Lu
and
Chunrong Tong and Beijing Daopei Hospital in Beijing, China to conduct a Phase
I
clinical study using Antigen’s novel immunotherapeutic strategy involving RNA
interference to develop a cancer cell vaccine for use in patients with acute
myeloid leukemia. In February 2008, some preliminary pre-clinical work commenced
under this clinical trial agreement.
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 January
31,
2008, 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 the fiscal years ending
July 31, 2005 and 2006, we believe that we have secured the funds necessary
to
continue in the short term to pursue late-stage clinical trials of Generex
Oral-lyn™ in the United States, Canada and Europe, to pursue the
commercialization of this product in Ecuador and India, and to seek regulatory
approval for this product in certain other countries. 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 six months, 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.
15
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, 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.
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 six months ended January 31, 2008, 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.
Preliminary pre-clinical work has commenced with respect to the experimental
vaccine for patients with acute myeloid leukemia at Beijing Daopei Hospital
in
China.
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 six months ended January 31, 2008, approximately
82%
of our $7,317,427 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 six months ended January
31, 2007, approximately 69% of our $4,075,015 in research expenses was
attributable to insulin and platform technology development, and we did not
have
any research expenses related to morphine or other buccal projects.
Approximately
18% or $1,310,155 of our research and development expenses for the six months
ended January 31, 2008 was related to Antigen's immunomedicine products
compared to approximately 31% or $1,242,950 for the six months ended January
31,
2007. 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 January 31, 2008 Compared to Three Months Ended January 31,
2007
Our
net
loss for the quarter ended January 31, 2008 was $6,507,174 versus $5,195,634
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 preparations for global Phase III clinical trials of Generex
Oral-lyn™ at sites in the United States, Canada, and Europe. Our operating loss
for the quarter ended January 31, 2008 increased to $6,828,022 compared to
$5,478,477 in the second fiscal quarter of 2007. The increase resulted from
an
increase in research and development expenses (to $3,469,624 from $2,482,082),
an increase in selling and marketing expenses (to $284,498 from $13,399), and
a
slight increase in general and administrative expenses (to $3,086,873 from
$3,006,951). Our revenues in the second quarter ended January 31, 2008 decreased
to $18,627 from $45,421 for the quarter ended January 31, 2007.
16
The
small
increase in general and administrative expenses for the quarter ended January
31, 2008 is due primarily to a modest increase in accounting, financial and
consulting expenses despite a modest decrease of legal expenses, advertising
and
sponsorship expenses and travel expenses. as compared to the same period last
year
The
increase in research and development expenses for the quarter ended January
31,
2008 reflects increased levels of research and development activities in
connection with preparation for commencement of Phase III clinical trials of
Generex Oral-lyn™ in Canada, the United States, Europe and Eastern
Europe.
Our
interest expense in the second fiscal quarter of 2008 decreased to $58,948
compared to interest expense of $275,164 in the second 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 second fiscal quarter of 2008
compared to $122,307 in the same quarter for the last year. Our interest income
decreased to $291,472 in the second fiscal quarter of 2008 compared to $601,125
in the same quarter for the last year primarily due to lower cash and short
term
investment balances during the current fiscal quarter and lower market interest
rates. We received a slightly higher income from rental operations (net of
expense) of $88,324 in the second fiscal quarter of 2008 compared to $79,189
in
the same quarter for the last year.
Results
of Operations
Six
Months Ended January 31, 2008 Compared to Six Months Ended January 31,
2007
Our
net
loss for the six months ended January 31, 2008 was $13,729,087 versus $8,853,679
in the corresponding six-month period of the prior fiscal year. The increase
in
net loss in this six-month period versus the corresponding six-month period
of
the prior fiscal year is primarily due to the increase in research and
development expenses in connection with preparations for global Phase III
clinical trials of Generex Oral-lyn™ at sites in the United States, Canada, and
Europe. This increase was significantly reduced by the decrease in interest
expense and loss on extinguishment of debt incurred in connection with
convertible debentures entered into during the 2006 fiscal year. Our operating
loss for the six months ended January 31, 2008 increased to $14,534,383 compared
to $9,458,659 in the corresponding six-month period ended January 31, 2007.
The
increase resulted from an increase in research and development expenses (to
$7,317,427 from $4,075,015) and increases in general and administrative expenses
(to $6,602,793 from $5,501,690) and selling expenses (to $651,918 from $13,399).
Our net revenues decreased to $63,340 in the six months ended January 31, 2008
from $184,426 in the six months ended January 31, 2007. The decrease in net
revenue is attributable to grant revenue received by Antigen in 2007 and
reduction in sales of Glucose RapidSpray™ in 2008 compared to stocking sales in
the same period last year.
The
increase in research and development expenses for the six-month period ended
January 31, 2008 reflects an increased level of research and development of
our
oral insulin product and platform technology and additional clinical trials.
The
increase in general and administrative expenses reflects the increase in legal,
financial, consulting expenses and an increase in executive compensation due
to
non-cash bonuses. The increase was offset by the reduction in accounting,
advertising and travel expenses. The selling expenses are associated with the
commercial sales of Glucose RapidSpray™ that began in fiscal 2007.
Our
interest expense in the six-month period ended January 31, 2008 decreased to
$116,622 compared to interest expense of $566,898 in the six-month period ended
January 31, 2007 due to no convertible debentures outstanding during fiscal
2008. Our loss on extinguishment of debt, also incurred in connection with
convertible debentures, was $0 in the six-month period ended January 31, 2008
compared to $180,825 in the six-month period ended January 31, 2007. Our
interest income decreased to $751,507 in the six-month period ended January
31,
2008 compared to $1,204,897 in the same period in the last fiscal year primarily
due to lower cash and short term investment balances during the current
six-month period and lower interest rates. We received a slightly higher income
from rental operations (net of expense) of $170,411 in the six months ended
January 31, 2008 compared to $147,806 in the six months ended January 31,
2007.
17
Developments
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 January 31, 2008, we did not engage in any
capital-raising transactions. At January 31, 2008, we had cash and
short-term investments of approximately $22.7 million, a decrease of $12.3
million from the balance as of the end of the prior fiscal year. As of January
31, 2008, 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
January 31, 2008, the following warrants issued under the auspices of the
Securities Purchase Agreement dated November 10, 2004 and amendments thereto
and
the Securities Purchase Agreement dated June 1, 2006 were
outstanding:
Date
Issued
|
Aggregate
No.
of
Shares Unexercised
|
Exercise
Price*
|
Exercise
Date
|
Expiration
Date
|
|||||||||||
January
23, 2006
|
622,226
|
$
|
1.60
|
June
2, 2006
|
July
22, 2011
|
||||||||||
February
27, 2006
|
4,770,617
|
$
|
3.00
|
August
27, 2006
|
August
27, 2011
|
||||||||||
February
28, 2006
|
172,120
|
$
|
1.25
|
August
31, 2006
|
August
31, 2011
|
||||||||||
March
1, 2006
|
800,000
|
$
|
3.00
|
September
6, 2006
|
September
6, 2011
|
||||||||||
June
1, 2006
|
2,560,980
|
$
|
2.45
|
June
1, 2006
|
June
1, 2011
|
||||||||||
June
2, 2006
|
3,273,144
|
$
|
2.35
|
June
2, 2006
|
June
2, 2011
|
*Subject
to anti-dilution adjustments upon issuance of securities at a price per share
of
common stock less than the then applicable exercise price or the market price
of
our common stock at that time, whichever is lower.
Critical
Accounting Policies
Our
discussion and analysis of our financial condition and results of operations
is
based on our consolidated financial statements which have been prepared in
conformity with accounting principles generally accepted in the United States
of
America. It requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual results
could differ from those estimates.
We
consider certain accounting policies related to impairment of long-lived assets,
intangible assets and accrued liabilities to be critical to our business
operations and the understanding of our results of operations:
18
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
The
following table of contractual obligations as of January 31, 2008 includes
interest 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
|
3,724,774
|
917,637
|
2,110,232
|
696,905
|
-
|
Capital
Lease Obligations
|
-
|
-
|
-
|
-
|
-
|
Operating
Lease Obligations
|
533,080
|
152,743
|
235,035
|
145,302
|
-
|
Purchase
Obligations
|
-
|
-
|
-
|
-
|
-
|
Other
Long-Term Liabilities Reflected on the
Registrant's
Balance Sheet under GAAP
|
-
|
-
|
-
|
-
|
-
|
Total
|
$4,257,854
|
$1,070,380
|
$2,345,267
|
$842,207
|
-
|
19
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 March 11, 2008 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 January
31, 2008 and 2007, we paid the management company approximately $13,141 and
$11,464, 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.
20
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
January 31, 2008.
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” (“SFAS 159”) 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 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 157. We are currently evaluating the
impact of this statement on our results of operations or financial
position.
In
December 2007, the FASB issued SFAS No. 141(R), “Business Combinations”
(“SFAS 141(R)”). This Statement replaces SFAS No. 141, “Business
Combinations” (“SFAS 141”). This Statement retains the fundamental requirements
in SFAS 141 that the acquisition method of accounting (which SFAS 141 called
the
purchase method) be used for all business combinations and for an acquirer
to be
identified for each business combination. This Statement also establishes
principles and requirements for how the acquirer: a) recognizes and measures
in
its financial statements the identifiable assets acquired, the liabilities
assumed, and any non-controlling interest in the acquiree; b) recognizes and
measures the goodwill acquired in the business combination or a gain from a
bargain purchase and c) determines what information to disclose to enable users
of the financial statements to evaluate the nature and financial effects of
the
business combination. SFAS 141(R) will apply prospectively to business
combinations for which the acquisition date is on or after the beginning of
the
first annual reporting period beginning on or after December 15, 2008. An entity
may not apply it before that date. We are currently evaluating the impact of
this statement on our results of operations or financial position.
21
In
December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements” (“SFAS 160”). This Statement amends ARB 51 to
establish accounting and reporting standards for the non-controlling (minority)
interest in a subsidiary and for the deconsolidation of a subsidiary. It
clarifies that a non-controlling interest in a subsidiary is an ownership
interest in the consolidated entity that should be reported as equity in the
consolidated financial statements. SFAS 160 is effective for fiscal years,
and
interim periods within those fiscal years, beginning on or after December 15,
2008. Earlier adoption is prohibited. 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 preparation
for
commencement of clinical trials in the United States and Europe, substantially
all of our operating expense obligations are denominated in Canadian dollars.
We
do not presently employ any hedging or similar strategy intended to mitigate
against losses that could be incurred as a result of fluctuations in the
exchange rates between U.S. and Canadian currencies.
As
of
January 31, 2008, we had fixed rate debt totaling $3,319,272. This amount
consists of the following:
Loan
Amount
|
|
Interest
Rate
per
Annum
|
|
|
468,991
|
|
|
6.82
|
%
|
284,855
|
|
|
6.82
|
%
|
704,901
|
|
|
7.60
|
%
|
404,155
|
|
|
8.50
|
%
|
217,465
|
|
|
10
|
%
|
1,238,905
|
|
|
6.07
|
%
|
3,319,272
|
|
|
Total
|
|
These
debt instruments mature from August 2008 through June 2011. As our fixed rate
debt instruments mature, we will likely refinance such debt at the existing
market interest rates which may be more or less than interest rates on the
maturing debt. Since this debt is fixed rate debt, if interest rates were to
increase 100 basis points prior to maturity, there would be no impact on
earnings or cash flows.
We
have
neither issued nor own any long-term debt instruments, or any other financial
instruments, for trading purposes and as to which we would be subject to
material market risks.
22
Item
4. Controls and Procedures.
Evaluation
of disclosure controls and procedures
Prior
to
the filing of this Quarterly Report on Form 10-Q, an evaluation was performed
under the supervision of and with the participation of our management, including
our Chief Executive Officer and Chief Financial Officer, of the effectiveness
of
our disclosure controls and procedures. Based on the evaluation our Chief
Executive Officer and Chief Financial Officer have concluded that, as of the
end
of the period covered by this Quarterly Report of Form 10-Q, the Company’s
disclosure controls and procedures were effective to ensure that information
required to be disclosed by the Company in reports that it files or submits
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is
recorded, processed, summarized and reported within the time periods specified
in the rules and forms of the SEC and is accumulated and communicated to the
Company’s management, as appropriate, to allow timely decisions regarding
required disclosures.
Changes
in internal control over financial reporting
There
was
no change in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15(d)-15(f) under the Exchange Act) during the period covered
by
this Quarterly Report on Form 10-Q that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
Subash
Chandarana et al. v. Generex Biotechnology Corporation.
In
February 2001, a former business associate of Pankaj Modi ("Modi") (a former
officer of the Company) and an entity called Centrum Technologies Inc. ("CTI")
commenced an action in the Ontario Superior Court of Justice against us and
Modi
seeking, among other things, damages for alleged breaches of contract and
tortious acts related to a business relationship between this former associate
and Modi that ceased in July 1996. The plaintiffs’ statement of claim also seeks
to enjoin the use, if any, by us of three patents allegedly owned by CTI. The
three patents are entitled Liquid
Formulations for Proteinic Pharmaceuticals,
Vaccine
Delivery System for Immunization, Using Biodegradable Polymer
Microspheres,
and
Controlled
Releases of Drugs or Hormones in Biodegradable Polymer
Microspheres.
It is
our position that the buccal drug delivery technologies which are the subject
matter of our research, development, and commercialization efforts, including
Generex Oral-lyn™ and the RapidMist™ Diabetes Management System, do not make use
of, are not derivative of, do not infringe upon, and are entirely different
from
the intellectual property identified in the plaintiffs’ statement of claim. On
July 20, 2001, we 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 us. Consequently, the shareholders of CBI are in a
deadlock. The court granted our 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 Modi and us. We 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 Modi and us. A
statement of claim was served in July 2004. Since that time, the plaintiffs
have
not taken any steps in furtherance of the proceeding. We are 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.
Newbridge
Securities Corporation v. Generex Biotechnology Corporation.
In
February, 2008, a securities broker-dealer and investment bank filed a complaint
against the Company in the Supreme Court of the State of New York alleging
breach of a business advisory agreement and seeking cash, stock, and warrant
compensation. The Company has not yet filed an answer to the complaint; we
are 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.
23
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 January 31, 2008, 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 assisting them with preparations for commercial
launch in India sometime in 2008. In January 2008, we commenced a marketing
campaign with a presentation to key opinion leaders and endocrinologists at
a
meeting in Mumbai, India.
To
date,
we have not been profitable and our accumulated net loss was $225,729,357 at
January 31, 2008. 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.
24
Risks
Related to Our Technologies
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 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 clinical trial in patients with prostate 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.
Item.
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
Unregistered
Sales of Equity Securities
In
the
fiscal quarter ended January 31, 2008, 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 January 31, 2008, 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 January 31, 2008, we issued 24,000 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.
25
During
the three months ended January 31, 2008, 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 January 31, 2008, we issued 37,500 shares of our
restricted common stock as partial consideration for the provision of services
by The Abajian Group, LLC under a consulting agreement with us. William Abajian,
a Business Development Consultant to Generex, is a principal of The Abajian
Group, LLC. 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.
In
November 2007, we issued an aggregate of 326,255 shares of our restricted common
stock to Nectid Inc. in consideration of the achievement of certain milestones
pursuant to the terms of our consulting agreement dated as of July 26, 2007
with
Nectid. Under this agreement, Nectid assisted us in early November 2007 in
procuring governmental approval for the importation, marketing, distribution,
and sale of Generex Oral-lyn in India. This agreement was terminated in
accordance with its terms on December 1, 2007. The sale of such shares was
exempt from registration under the Securities Act in reliance upon Section
4(2)
thereof. We believe that Nectid is an “accredited investor” as that term is
defined in Rule 501(a) of Regulation D under the Securities Act. The
certificates issued for the shares of common stock will be legended to indicate
that they are restricted. The sales of such securities did not involve the
use
of underwriters, and no commissions were paid in connection therewith.
Issuer
Purchases of Equity Securities
Neither
we nor any affiliated purchaser (as defined in Section 240.10 b-18(a)(3) of
the
Exchange Act) purchased any of our equity securities during the fiscal quarter
ended January 31, 2008.
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.
26
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)
|
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)
|
27
4.4.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.4.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
|
|
4.5.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.3
|
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.5.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
4.8.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
28
4.8.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.3
|
|
Warrant
issued in connection with Exhibit 4.9.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.9.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.10.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.10.3
|
|
Form
of Warrant issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.10.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.11.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
4.11.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.4
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
4.12
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|
|
|
4.13.1
|
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
29
4.13.2
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
|
|
|
4.14
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|
|
|
4.15.1
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.2
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.3
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.4
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
|
|
4.15.5
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.16.1
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.2
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.3
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.4
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
4.16.5
|
|
Form
of Additional AIR Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
4.16.6
|
|
Form
of Additional AIR Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
30
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)
|
|
|
|
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.
|
|
31
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
|
|
|
GENEREX
BIOTECHNOLOGY CORPORATION
(Registrant)
|
|
|
|
|
Date:
March 11, 2008
|
By:
|
/s/ Anna
E. Gluskin
|
|
Anna
E. Gluskin
President
and Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
|
Date:
March 11, 2008
|
By:
|
/s/ Rose
C. Perri
|
|
Rose
C. Perri
Chief
Financial Officer
|
32
Generex
Biotechnology Corporation
Form
10-Q
January
31, 2008
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)
|
|
|
|
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)
|
|
|
|
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
4.8.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.3
|
|
Warrant
issued in connection with Exhibit 4.9.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.9.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.10.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.10.3
|
|
Form
of Warrant issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.10.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.11.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
4.11.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.4
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
4.12
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|
|
|
4.13.1
|
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
|
|
|
4.13.2
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
|
|
|
4.14
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|
|
|
4.15.1
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.2
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.3
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.4
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
|
|
4.15.5
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.16.1
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.2
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.3
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.4
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
4.16.5
|
|
Form
of Additional AIR Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
4.16.6
|
|
Form
of Additional AIR Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.17.1
|
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
|
|
|
4.17.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
|
|
|
|
4.18
|
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006)
|
|
|
|
4.19
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
|
|
|
4.20.1
|
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
|
|
|
|
4.20.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
|
|
|
|
4.21.1
|
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
|
|
|
4.21.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.39 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
|
|
|
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)
|
|
|
|
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.
|
|