GENEREX BIOTECHNOLOGY CORP - Quarter Report: 2008 April (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x QUARTERLY
REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT OF 1934
For
the
quarterly period ended April 30, 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, or a non-accelerated filer or a smaller reporting company.
See the definitions of “large accelerated filer,” “accelerated filer,” and
“smaller reporting company” in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer o
|
Accelerated
filer x
|
||
Non-accelerated
filer o
|
Smaller
reporting company o
|
(Do
not
check if a 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 112,180,123 as of May 21, 2008.
GENEREX
BIOTECHNOLOGY CORPORATION
INDEX
PART
I. FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial
Statements.
|
|
|
|
(Unaudited)
|
|
Consolidated
Balance Sheets -
|
|
April
30, 2008 and July 31, 2007
|
3
|
|
|
Consolidated
Statements of Operations — For the three and nine
month
|
|
periods
ended April 30, 2008 and 2007, and cumulative from
|
|
November
2, 1995 to April 30, 2008
|
4
|
|
|
Consolidated
Statements of Cash Flows — For the nine month
|
|
periods
ended April 30, 2008 and 2007, and cumulative from
|
|
November
2, 1995 to April 30, 2008
|
5
|
|
|
Notes
to Consolidated Financial Statements
|
6
|
|
|
Item
2. Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
16
|
|
|
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
|
30
|
|
|
Item
4. Controls
and Procedures
|
30
|
|
|
PART
II: OTHER INFORMATION
|
|
|
|
Item
1. Legal
Proceedings
|
31
|
Item
1A. Risk
Factors
|
31
|
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
|
32
|
|
|
Item
3. Defaults
Upon Senior Securities
|
33
|
|
|
Item
4. Submission
of Matters to a Vote of Security Holders
|
33
|
|
|
Item
5. Other
Information
|
33
|
|
|
Item
6. Exhibits
|
34
|
|
|
Signatures
|
40
|
2
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
BALANCE SHEETS
April 30,
|
July 31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
Assets:
|
|||||||
Cash
and cash equivalents
|
$
|
15,341,824
|
$
|
21,026,067
|
|||
Short-term
investments
|
21,045,167
|
14,011,738
|
|||||
Accounts
receivable
|
90,758
|
58,264
|
|||||
Inventory
|
855,382
|
123,931
|
|||||
Other
current assets
|
502,329
|
469,210
|
|||||
Deferred
debt issuance costs
|
615,167
|
—
|
|||||
Total
Current Assets
|
38,450,627
|
35,689,210
|
|||||
Deferred
debt issuance costs
|
256,319
|
—
|
|||||
Property
and Equipment, Net
|
1,852,026
|
2,137,027
|
|||||
Assets
Held for Investment, Net
|
3,785,611
|
3,693,183
|
|||||
Patents,
Net
|
4,760,326
|
4,884,984
|
|||||
TOTAL
ASSETS
|
$
|
49,104,909
|
$
|
46,404,404
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
9,373,549
|
$
|
7,156,709
|
|||
Deferred
revenue and rebate liability
|
104,345
|
33,314
|
|||||
Current
maturities of long-term debt
|
1,862,849
|
84,503
|
|||||
Convertible
debentures, net of debt discount of $19,006,313 and $-0- at April
30, 2008
and July 31, 2007, respectively
|
1,643,687
|
—
|
|||||
Total
Current Liabilities
|
12,984,430
|
7,274,526
|
|||||
Long-Term
Debt, Net
|
1,380,142
|
3,059,286
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
Equity:
|
|||||||
Special
Voting Rights Preferred Stock, $.001 par value; authorized 1,000
shares at
April 30, 2008 and July 31, 2007; -0- shares issued and outstanding
at
April 30, 2008 and July 31, 2007
|
—
|
—
|
|||||
Common
stock, $.001 par value; authorized 500,000,000 shares at April 30,
2008
and July 31, 2007; 111,853,868 and 109,616,518 shares issued and
outstanding at April 30, 2008 and July 31, 2007,
respectively
|
111,853
|
109,616
|
|||||
Additional
paid-in capital
|
269,598,328
|
247,079,439
|
|||||
Deficit
accumulated during the development stage
|
(235,903,538
|
)
|
(212,000,270
|
)
|
|||
Accumulated
other comprehensive income
|
933,694
|
881,807
|
|||||
Total
Stockholders’ Equity
|
34,740,337
|
36,070,592
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
49,104,909
|
$
|
46,404,404
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
3
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED)
Cumulative From
|
||||||||||||||||
November 2, 1995
|
||||||||||||||||
For the Nine Months Ended
|
For the Three Months Ended
|
(Date of Inception)
|
||||||||||||||
April 30,
|
April 30,
|
to April 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
2008
|
||||||||||||
Revenues
|
$
|
67,431
|
$
|
196,867
|
$
|
2,100
|
$
|
11,939
|
$
|
2,444,156
|
||||||
Sales
discounts
|
(2,561
|
)
|
(1,481
|
)
|
(570
|
)
|
(979
|
)
|
(4,792
|
)
|
||||||
Net
Revenue
|
64,870
|
195,386
|
1,530
|
10,960
|
2,439,364
|
|||||||||||
Cost
of Goods Sold
|
26,224
|
69,020
|
639
|
16,039
|
87,847
|
|||||||||||
Operating
Expenses:
|
||||||||||||||||
Research
and development
|
11,620,817
|
8,373,393
|
4,303,390
|
4,177,070
|
85,077,281
|
|||||||||||
Research
and development - related party
|
—
|
—
|
—
|
—
|
220,218
|
|||||||||||
Selling
and marketing
|
1,070,722
|
214,089
|
418,804
|
73,503
|
1,820,059
|
|||||||||||
General
and administrative
|
11,733,562
|
9,003,615
|
5,130,769
|
3,750,420
|
101,772,980
|
|||||||||||
General
and administrative - related party
|
—
|
—
|
—
|
—
|
314,328
|
|||||||||||
Total
Operating Expenses
|
24,425,101
|
17,591,097
|
9,852,963
|
8,000,993
|
189,204,866
|
|||||||||||
Operating
Loss
|
(24,386,455
|
)
|
(17,464,731
|
)
|
(9,852,072
|
)
|
(8,006,072
|
)
|
(186,853,349
|
)
|
||||||
Other
Income (Expense):
|
||||||||||||||||
Miscellaneous
income (expense)
|
70
|
—
|
70
|
—
|
196,263
|
|||||||||||
Income
from rental operations, net
|
250,195
|
120,197
|
79,784
|
33,262
|
1,171,123
|
|||||||||||
Interest
income
|
958,457
|
1,719,169
|
206,950
|
514,272
|
7,300,915
|
|||||||||||
Interest
expense
|
(725,535
|
)
|
(709,507
|
)
|
(608,913
|
)
|
(203,480
|
)
|
(44,327,550
|
)
|
||||||
Loss
on extinguishment of debt
|
—
|
(237,162
|
)
|
—
|
(56,337
|
)
|
(14,134,068
|
)
|
||||||||
Net
Loss Before Undernoted
|
(23,903,268
|
)
|
(16,572,034
|
)
|
(10,174,181
|
)
|
(7,718,355
|
)
|
(236,646,666
|
)
|
||||||
Minority
Interest Share of Loss
|
—
|
—
|
—
|
—
|
3,038,185
|
|||||||||||
Net
Loss
|
(23,903,268
|
)
|
(16,572,034
|
)
|
(10,174,181
|
)
|
(7,718,355
|
)
|
(233,608,481
|
)
|
||||||
Preferred
Stock Dividend
|
—
|
—
|
—
|
—
|
2,295,057
|
|||||||||||
Net
Loss Available to Common Shareholders
|
$
|
(23,903,268
|
)
|
$
|
(16,572,034
|
)
|
$
|
(10,174,181
|
)
|
$
|
(7,718,355
|
)
|
$
|
(235,903,538
|
)
|
|
Basic
and Diluted Net Loss Per Common Share
|
$
|
(.22
|
)
|
$
|
(.15
|
)
|
$
|
(.09
|
)
|
$
|
(.07
|
)
|
||||
Weighted
Average Number of Shares of Common Stock Outstanding
|
110,758,728
|
108,125,504
|
111,282,111
|
108,623,690
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
4
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
STATEMENTS OF CASH FLOWS (UNAUDITED)
Cumulative From
|
||||||||||
November 2, 1995
|
||||||||||
For the Nine Months Ended
|
(Date of Inception)
|
|||||||||
April 30,
|
to April 30,
|
|||||||||
2008
|
2007
|
2008
|
||||||||
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
$
|
(23,903,268
|
)
|
$
|
(16,572,034
|
)
|
$
|
(233,608,481
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and amortization
|
846,552
|
866,505
|
6,728,498
|
|||||||
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
|
—
|
237,163
|
14,134,069
|
|||||||
Common
stock issued as employee compensation
|
1,109,692
|
722,826
|
3,403,272
|
|||||||
Common
stock issued for services rendered
|
1,429,061
|
741,255
|
8,425,377
|
|||||||
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
|
82,000
|
125,000
|
7,354,723
|
|||||||
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
|
51,264
|
—
|
1,534,143
|
|||||||
Amortization
of discount on convertible debentures
|
408,851
|
608,737
|
19,339,278
|
|||||||
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
|
(39,392
|
)
|
(84,504
|
)
|
(96,072
|
)
|
||||
Miscellaneous
receivables
|
—
|
—
|
43,812
|
|||||||
Inventory
|
(728,681
|
)
|
(46,711
|
)
|
(846,183
|
)
|
||||
Other
current assets
|
79,714
|
15,485
|
(48,999
|
)
|
||||||
Accounts
payable and accrued expenses
|
2,662,777
|
1,209,487
|
13,990,892
|
|||||||
Deferred
revenue
|
70,897
|
27,141
|
103,928
|
|||||||
Other,
net
|
—
|
—
|
110,317
|
|||||||
Net
Cash Used in Operating Activities
|
(17,930,533
|
)
|
(12,130,837
|
)
|
(135,818,810
|
)
|
||||
Cash
Flows From Investing Activities:
|
||||||||||
Purchase
of property and equipment
|
(55,461
|
)
|
(77,208
|
)
|
(4,591,872
|
)
|
||||
Costs
incurred for patents
|
(185,555
|
)
|
(149,243
|
)
|
(2,003,157
|
)
|
||||
Change
in restricted cash
|
—
|
—
|
45,872
|
|||||||
Proceeds
from maturity of short term investments
|
16,984,782
|
22,285,763
|
175,067,591
|
|||||||
Purchases
of short-term investments
|
(24,018,211
|
)
|
(22,260,892
|
)
|
(196,112,758
|
)
|
||||
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
|
(95,102
|
)
|
(150,082
|
)
|
(798,392
|
)
|
||||
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
|
(7,369,547
|
)
|
(351,662
|
)
|
(31,692,451
|
)
|
||||
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
|
(66,596
|
)
|
(53,079
|
)
|
(1,918,965
|
)
|
||||
Change
in due to related parties
|
—
|
—
|
154,541
|
|||||||
Proceeds
from exercise of warrants
|
—
|
125,000
|
44,015,049
|
|||||||
Proceeds
from exercise of stock options
|
391,790
|
176,983
|
4,945,916
|
|||||||
Proceeds
from minority interest investment
|
—
|
—
|
3,038,185
|
|||||||
Proceeds
from issuance of preferred stock
|
—
|
—
|
12,015,000
|
|||||||
Redemption
of SVR preferred stock
|
—
|
(100
|
)
|
(100
|
)
|
|||||
Proceeds
from issuance of convertible debentures, net
|
20,450,000
|
—
|
40,704,930
|
|||||||
Payment
of costs associated with convertible debentures
|
(722,750
|
)
|
—
|
(722,750
|
)
|
|||||
Repayments
of convertible debentures
|
—
|
(150,030
|
)
|
(635,757
|
)
|
|||||
Purchase
of treasury stock
|
—
|
—
|
(483,869
|
)
|
||||||
Proceeds
from issuance of common stock, net
|
—
|
—
|
80,283,719
|
|||||||
Purchase
and retirement of common stock
|
(378,456
|
)
|
—
|
(497,522
|
)
|
|||||
Net
Cash Provided by Financing Activities
|
19,673,988
|
98,774
|
182,881,796
|
|||||||
Effect
of Exchange Rates on Cash
|
(58,151
|
)
|
(11,276
|
)
|
(28,711
|
)
|
||||
|
||||||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(5,684,243
|
)
|
(12,395,001
|
)
|
15,341,824
|
|||||
Cash
and Cash Equivalents, Beginning of Period
|
21,026,067
|
38,208,493
|
—
|
|||||||
Cash
and Cash Equivalents, End of Period
|
$
|
15,341,824
|
$
|
25,813,492
|
$
|
15,341,824
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
5
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 nine 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
April
30, 2008.
6
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements" ("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.
7
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.
In
March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities,” and Amendment of FASB Statement No. 133. SFAS 161
amends SFAS 133, “Accounting for Derivative Instruments and Hedging Activities,”
to amend and expand the disclosure requirements of SFAS 133 to provide greater
transparency about (i) how and why an entity uses derivative instruments,
(ii)
how derivative instruments and related hedge items are accounted for under
SFAS
133 and its related interpretations, and (iii) how derivative instruments
and
related hedged items affect an entity’s financial position, results of
operations and cash flows. To meet those objectives, SFAS 161 requires
qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of gains and losses on
derivative instruments and disclosures about credit-risk-related contingent
features in derivative agreements. SFAS 161 is effective for fiscal years
and
interim periods beginning after November 15, 2008. Earlier adoption is
encouraged. The Company is currently evaluating the impact of SFAS 161 on
its
financial position, results of operations or cash flows.
4. |
Stock-Based
Compensation
|
As
of
April 30, 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 April 30, 2008, there were 2,000,000, 2,612,490 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.
8
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 nine months ended April 30,
2008,
however, the Company extended the term of 300,000 options for an additional
30
days and recorded an additional charge to operations in the amount of $14,500.
The
summary of the stock option activity for the nine months ended April 30,
2008 is
as follows:
Weighted
Average
|
Weighted
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
|
(401,000
|
)
|
$
|
0.98
|
|||||||||
Outstanding,
April 30, 2008
|
6,071,638
|
$
|
0.65
|
1.55
|
$
|
3,160,533
|
|||||||
Exercisable,
April 30, 2008
|
6,071,638
|
$
|
0.65
|
1.55
|
$
|
3,160,533
|
|||||||
$
|
1.56
|
||||||||||||
Total
Intrinsic Value of Options Exercised
|
$
|
103,850
|
As
of
April 30, 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 nine months ended April 30, 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 11). These shares were fully vested
on the
date of grant.
9
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
August
2007, the Company issued 550,000 shares of common stock under the 2006 Plan
in
the form of restricted stock awards to officers. The fair value of these
shares
based on the quoted market price of the Company’s common stock on the dates of
the issuance is $830,500. These shares were issued as an incentive to retain
key
employees and officers. A portion of these shares vested immediately while
the
remaining portion will vest over two years from the date of the grant. The
following table summarizes the Company’s non-vested restricted stock activity
for the nine months ended April 30, 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, April 30, 2008
|
237,500
|
$
|
1.51
|
As
of
April 30, 2008, approximately $168,105 of total unrecognized compensation costs
related to unvested shares is expected to be recognized over the remaining
service period of 1.5 years.
5. |
Comprehensive
Income/(Loss)
|
Comprehensive
loss, which includes net loss and the change in the foreign currency translation
account during the period, for the nine months ended April 30, 2008 and 2007,
was $23,851,381 and $16,560,498, respectively, and for the three months ended
April 30, 2008 and 2007, was $10,224,202 and $7,607,610,
respectively.
6. |
Accounts
Payable and Accrued
Expenses
|
Accounts
payable and accrued expenses consist of the following:
April 30,
|
July 31,
|
||||||
2008
|
2007
|
||||||
Accounts
Payable
|
$
|
3,815,481
|
$
|
1,791,080
|
|||
Research
and Development
|
1,456,318
|
1,956,049
|
|||||
Executive
Compensation
|
3,722,911
|
2,252,978
|
|||||
Financial
Services
|
378,839
|
1,156,602
|
|||||
Total
|
$
|
9,373,549
|
$
|
7,156,709
|
10
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
7. |
Secured
Convertible
Notes
|
The
secured convertible notes are accounted for in accordance with EITF 98-5
and
00-27. The following summarizes the significant terms and accounting for
each
convertible note entered into by the Company.
Notes/Debenture
|
||||
$20,650,000
|
||||
Date
Issued
|
3/2008
|
|||
Promissory
Note Amount
|
$
|
(A
|
)
|
|
#
of Promissory Notes
|
6
|
|||
Terms
|
(B
|
)
|
||
Conversion
Price
|
$
|
1.21
|
||
Gross
Proceeds
|
$
|
20,650,000
|
||
Net
Cash Proceeds
|
$
|
20,450,000
|
||
Warrants
Issued to Investors (C)
|
42,665,274
|
|||
Warrant
Exercise Price
|
$
|
1.21
|
||
Existing
Warrants Re-priced (D)
|
12,697,024
|
|||
Re-priced
Warrant Exercise Price (D)
|
1.10
|
|||
Warrant
Fair Value (WFV) (includes value of re-priced warrants)
|
$
|
21,976,130
|
||
Warrant
Relative Fair Value (WRFV)
|
$
|
10,646,218
|
||
Black
Scholes Model Assumptions
|
(E
|
)
|
||
Beneficial
Conversion Feature (BCF)
|
$
|
8,768,946
|
||
Amortization
of WFV and BCF as
|
||||
Non-cash
Interest Expense
|
$
|
408,851
|
||
Principal
and Interest Converted
|
$
|
—
|
||
Loss
on Extinguishment
|
$
|
—
|
||
Shares
Issued Upon Conversion
|
—
|
|||
Principal
and Interest Repayments
|
||||
in
Shares of Common Stock
|
$
|
—
|
||
Loss
on Extinguishment (C)
|
$
|
—
|
||
Shares
Issued for Principal and
|
||||
Interest
Repayments
|
—
|
|||
Principal
and Interest Repayments
|
||||
in
Cash
|
$
|
—
|
As
of
April 30, 2008, the $1,643,687 net outstanding balance of convertible notes
is
comprised of $20,650,000 of debt net of unamortized debt discount of
$19,006,313.
(A) |
$7,000,000;
$5,000,000; $3,650,000; (2) $2,000,000;
$1,000,000
|
(B) |
The
notes carry an 8% coupon and mature September 30, 2009, provided,
however,
the maturity date may be extended at the option of the holder.
The notes
carry a 19-month term and amortization in 15 assignments commencing
in the
fifth month of the term. The principal and interest payments are
payable
in cash or, at the Company's option, the lower of (i) the then
applicable
conversion price and (ii) the price which shall be computed as
90% of the
arithmetic average of the VWAP of the common stock on each of the
twenty
(20) consecutive trading days immediately preceding the applicable
installment date, subject to certain
conditions.
|
11
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(C) |
The
warrants issued to investors are comprised of the following: Series
A
warrants 5,257,729; Series A-1 warrants 7,541,857; Series B warrants
17,066,108; Series C warrants 12,799,580.
|
a. |
The
Series C warrants are issuable contingent upon exercise of
Series B
warrants. The relative fair value associated with the Series
C warrants at
the commitment date amounted to $1,234,836. At such time the
contingency
is met, the Company would include the relative fair value as
a charge to
interest expense. The Company has accounted for this contingency
in
accordance with EITF 98-5 and 00-27.
|
(D) |
The
Company re-priced 12,697,024 existing warrants. The value associated
with
the re-priced warrants amounted to $5,399,160 and valued using
the
Black-Scholes pricing model. The value of the re-priced warrants
have been
added to the value of the new warrants issued (see (C) above) and
accounted for in accordance with EITF 98-5 and
00-27.
|
(E) |
Black
Scholes pricing model assumptions used in valuing the warrants
were: risk
free interest (2.70 percent); expected volatility (.8611); life
of 1 ½
years, 7 years and 7 ½ years.
|
8. |
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 known as 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. 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
the Company’s position that the buccal drug delivery technologies which are the
subject matter of the Company’s 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, 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.
12
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company is involved in certain other legal proceedings in addition to those
specifically described herein. Subject to the uncertainty inherent in all
litigation, the Company does not believe at the present time that the resolution
of any of these legal proceedings is likely to have a material adverse effect
on
the Company’s financial position, operations or cash flows.
With
respect to all litigation, as additional information concerning the estimates
used by the Company becomes known, the Company reassesses its position both
with
respect to accrued liabilities and other potential exposures.
9. |
Net
Loss Per Share
|
Basic
EPS
and Diluted EPS for the nine and three months ended April 30, 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 and shares
issuable upon conversion of convertible notes, approximately 80,294,695
incremental shares, at April 30, 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
23,513,115 incremental shares, at April 30, 2007 have been excluded from
the
computation of Diluted EPS as they are anti-dilutive.
10. |
Supplemental
Disclosure of Cash Flow
Information
|
For the Nine Months Ended
|
|||||||
April 30,
|
|||||||
2008
|
2007
|
||||||
Cash
paid during the period for:
|
|||||||
Interest
|
$
|
174,428
|
$
|
196,368
|
|||
Income
taxes
|
$
|
—
|
$
|
—
|
|||
Disclosure
of non-cash investing and financing activities:
|
|||||||
Issuance
of common stock as satisfaction of accrued executive
compensation
|
$
|
471,875
|
$
|
—
|
|||
Deferred
debt issuance costs paid from the proceeds of convertible
notes
|
$
|
200,000
|
$
|
—
|
|||
Value
of warrants issued in conjunction with issuance of convertible
debentures
and related beneficial conversion feature
|
$
|
19,415,164
|
$
|
—
|
|||
Principal
repayment of convertible debentures through the of
common stock
|
$
|
—
|
$
|
384,616
|
|||
Issuance
of common stock in conjunction with convertible debenture
conversion
|
$
|
—
|
$
|
210,216
|
11. |
Stockholders’
Equity
|
During
the nine months ended April 30, 2008, the Company issued 1,011,851 shares
of
common stock to various consultants for services rendered in the amount of
$1,429,061. The shares were valued at $0.95 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 nine months ended April 30, 2008, the Company issued 600,754 shares of
common stock valued at $904,672 as employee compensation, including 546,000
shares issued under 2006 Stock Option Plan (see Note 4). The shares were
valued
at $1.04 to $1.75 per share based on the quoted market price of the Company’s
common stock on the dates of the issuances.
13
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
During
the nine months ended April 30, 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 nine months ended April 30, 2008, the Company received aggregate cash
proceeds of $391,790 from exercises of stock options. The Company issued
401,000
shares of common stock as a result of these transactions.
During
the nine months ended April 30, 2008, the Company issued 175,000 warrants
in
exchange for services rendered. The warrants were fully vested on date of
issuance and exercisable at $0.94 and $3.75 each for the purchase of one
share
of the Company’s common stock. The warrants, which were valued using the Black
Scholes pricing model, resulted in charges to the statement of operations
of
$82,000.
During
the nine months ended April 30, 2008, the Company issued secured convertible
notes for an aggregate proceeds of $20,650,000. In connection with this
investment, the Company agreed to issue several series of warrants to purchase
an aggregate of 42,665,274 shares of the Company’s common stock at the exercise
price of $1.21 per share exercisable for periods ranging from 7 to 7 ½ years
following the issuance thereof and, in the case of the Series B Warrants,
for a
period of 18 months from the effective date of the registration statement
covering all the registrable securities (see Note 7). Additionally, the Company
re-priced 12,697,024 existing warrants. The value of the re-priced warrants
have
been added to the value of the issued warrants and accounted for in accordance
with EITF 98-5 and 00-27 (see Note 7).
During
the nine months ended April 30, 2008, the Company modified certain outstanding
stock options (see Note 4).
The
stockholders’ equity transactions as described above are summarized as
follow:
Common Stock
|
Additional
Paid-In
|
Total
Stockholders’
|
|||||||||||
Shares
|
|
Amount
|
|
Capital
|
|
Equity
|
|
||||||
Issuance of common stock for services
|
1,011,851
|
$
|
1,012
|
$
|
1,428,049
|
$
|
1,429,061
|
||||||
Issuance of warrants for services
|
—
|
—
|
82,000
|
82,000
|
|||||||||
Issuance
of common stock as employee compensation
|
600,754
|
601
|
904,071
|
904,672
|
|||||||||
Issuance
of common stock as executive compensation
|
550,000
|
550
|
(550
|
)
|
—
|
||||||||
Stock-based
executive compensation
|
—
|
—
|
190,518
|
190,518
|
|||||||||
Issuance
of common stock in satisfaction
|
|||||||||||||
of
accrued executive compensation
|
—
|
—
|
471,875
|
471,875
|
|||||||||
Stocks
options exercised for cash
|
401,000
|
401
|
391,389
|
391,790
|
|||||||||
Issuance
of warrants in connection with
|
|||||||||||||
convertible
notes
|
—
|
—
|
19,415,164
|
19,415,164
|
|||||||||
Total
|
2,563,605
|
$
|
2,564
|
$
|
22,882,516
|
$
|
22,885,080
|
14
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
12. |
Subsequent
Events
|
During
May 2008, the Company granted 175,000 options to executives to purchase common
stock with an exercise price of $0.96 per share and vesting over a 2 year
period. The fair value of the options on the date of grant amounted to
$103,250.
15
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
As
used
herein, the terms the “Company,” “Generex,” “we,” “us,” or “our” refer to
Generex Biotechnology Corporation, a Delaware corporation. The following
discussion and analysis by management provides information with respect to
our
financial condition and results of operations for the three- and nine-month
periods ended April 30, 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 April 30,
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 April 30, 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.
|
16
Additional
factors that could affect future results are set forth in Part
I, Item 1A Risk Factors
of our
Annual Report on Form 10-K for the year ended July 31, 2007, as amended, and
in
Part
II, Item 1A. Risk Factors
of this
Quarterly Report on Form 10-Q. We caution investors that the forward-looking
statements contained in this Quarterly Report must be interpreted and understood
in light of conditions and circumstances that exist as of the date of this
Quarterly Report. We expressly disclaim any obligation or undertaking to update
or revise forward-looking statements to reflect any changes in management's
expectations resulting from future events or changes in the conditions or
circumstances upon which such expectations are based.
Executive
Summary
About
the Company
We
are
engaged primarily in the research, development, and commercialization of drug
delivery systems and technologies. Our primary focus at the present time is
our
proprietary technology for the administration of formulations of large molecule
drugs to the oral (buccal) cavity. Through our wholly-owned subsidiary, Antigen
Express, Inc., we are pursuing research and development of 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 of
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, 2007, we have received only limited revenues from operations. In the fiscal
year ended July 31, 2007, we received approximately $136,448 in revenues from
sales of Glucose RapidSpray™. In the nine-month period ending April 30, 2008, we
received approximately $64,870 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
the
remainder of fiscal 2008 and thereafter, 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 early June 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).
17
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 August 2007 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, for the
registration, importation, marketing, distribution, and sale of Generex
Oral-lyn™ in the Republic of India, the Islamic Republic of Pakistan, the
People’s Republic of Bangladesh, the Kingdom of Nepal, the Kingdom of Bhutan,
the Democratic Socialist Republic of Sri Lanka, and the Union of Myanmar. 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
the
remainder of 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 calendar year
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 Leosons General Trading Company,
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.
In
October, 2007 we entered into a product licensing and distribution agreement
with Adcock Ingram Limited and Adcock Ingram Healthcare (Pty) Ltd. for the
registration, importation, marketing, distribution and sale of Generex Oral-lyn™
in the Republic of South Africa, the Kingdom of Lesotho, the Kingdom of
Swaziland, the Republic of Botswana, the Republic of Namibia, the Republic
of
Mozambique, and the Republic of Zimbabwe. In February, 2008 we entered into
a
product licensing and distribution agreement with E&V Alca Distribution
Corp. for the registration, importation, marketing, distribution, and sale
of
Generex Oral-lyn™ in the Republic of Albania, Montenegro, and the Kosovo. In
April, 2008 we entered into a product licensing and distribution agreement
with
SciGen, Ltd. for the registration, importation, marketing, distribution, and
sale of Generex Oral-lyn™ in the People’s Republic of China, Hong Kong, the
Republic of Indonesia, the Republic of Korea, Malaysia, the Republic of the
Philippines, the Republic of Singapore, the Kingdom of Thailand, and the
Socialist Republic of Vietnam. In April 2008, Generex and Medrey S.A.L.
(formerly MedGen Corp.) entered into a sub-distribution agreement with Benta
S.A.L. in respect of the registration, marketing, distribution, and sale of
Generex Oral-lyn™ in the Republic of Lebanon.
We
face
competition from other providers of alternate forms of insulin. Some of our
most
significant competitors, Pfizer, Eli Lilly, and Novo Nordisk, recently announced
their decisions to discontinue development and/or sale of their inhalable forms
of insulin. Generex Oral-lyn™ is not an inhaled insulin; rather, it is a bucally
absorbed formulation with no residual pulmonary deposition. 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.
18
Buccal
Glucose and Energy Products - Glucose RapidSpray™, BaBOOM! ™ Energy Spray and
GlucoBreak™
With
the
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
calendar 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 filling the order
and partial shipments have been made.
Metformin
Gum Product/Strategic Alliance
During
the remainder of fiscal 2008 and thereafter, 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 HER-2/neu positive breast cancer in a
Phase
II clinical trial and patients with prostate cancer and against avian influenza
in two Phase I trials. 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 compare the rate of relapse after two years in breast cancer patients
treated with Antigen’s immunotherapeutic plus adjuvant versus adjuvant alone.
All patients will 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 being used in breast cancer patients
is currently underway for prostate cancer patients at two hospital sites in
Athens, Greece.
The
Lebanese-Canadian Hospital in Beirut, Lebanon commenced a Phase I clinical
trial
of Antigen’s synthetic avian influenza vaccine in April 2007 and 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 and
India will not be sufficient for all of our cash needs during the remainder
of
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 April 30, 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 the recent debt financing with a limited group of
investors. We believe that the terms of this financing was favorable to us.
Through this financing transactions that we closed in March 2008, 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.
The
recent debt financing is described in detail below under “Financial Condition,
Liquidity and Resources - Secured Convertible Notes and Warrants.”
19
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 examining options for the procurement of a reliable
long-term 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 nine 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.
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 nine months ended April 30, 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.
20
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 nine months ended April 30, 2008,
approximately 82.5% of our $11,620,817 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
nine
months ended April 30, 2007, approximately 72% of our $8,373,393 in research
expenses was attributable to insulin and platform technology development, and
we
did not have any research expenses related to morphine or other buccal projects.
Approximately
17.5% or $2,037,417 of our research and development expenses for the nine months
ended April 30, 2008 was related to Antigen's immunomedicine products
compared to approximately 28% or $2,390,502 of our research and development
expenses for the nine months ended April 30, 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. Due to the early stage of development, we cannot predict the timing
of
completion of any products arising from this technology, or when products from
this technology might begin producing revenues.
Results
of Operations
Three
Months Ended April 30, 2008 Compared to Three Months Ended April 30,
2007
Our
net
loss for the quarter ended April 30, 2008 was $10,174,181 versus $7,718,355
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, the increase in
general and administrative and selling expenses and increased interest expense
incurred in connection with interest payments due on recently issued secured
convertible notes. Our operating loss for the quarter increased to $9,852,072
compared to $8,006,072 in the third fiscal quarter of 2007. The increase
resulted from an increase in research and development expenses (to $4,303,390
from $4,177,070), an increase in selling expense (to $418,804 from $73,503)
and
an increase in general and administrative expenses (to $5,130,769 from
$3,750,420). Our net revenues decreased from $10,960 in the quarter ended April
30, 2007 to $1,530 in the quarter ended April 30, 2008.
The
increase in general and administrative expenses for the quarter ended April
30,
2008 is due primarily to a increase in cash and non cash executive compensation,
financial and consulting expenses as well as legal costs. The increase was
partially offset by the reduction of accounting and travel expenses as compared
to the same period last year.
The
increase in research and development expenses for the quarter ended April 30,
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 fiscal quarter ended April 30, 2008 increased to
$608,913 compared to interest expense of $203,480 in the fiscal quarter ended
April 30, 2007 due to interest paid on secured convertible notes issued in
March
2008. Our interest income decreased to $206,950 in the fiscal quarter ended
April 30, 2008, compared to $514,272 in the same quarter for the last fiscal
year. The decrease in interest income is primarily due to lower cash and short
term investment balances at the beginning of the current fiscal quarter and
lower market interest rates. We received higher income from rental operations
(net of expense) of $79,784 in the fiscal quarter ended April 30, 2008 compared
to $33,262 in the same quarter for the last fiscal year. In the fiscal quarter
ended April 30, 2008, we did not incur loss on extinguishment of debt reflecting
monthly amortization payments due on the recently issued secured convertible
notes. In the fiscal quarter ended April 30, 2007, our loss on extinguishment
of
debt was $56,337.
21
Results
of Operations
Nine
Months Ended April 30, 2008 Compared to Nine Months Ended April 30,
2007
Our
net
loss for the nine months ended April 30, 2008 was $23,903,268 versus $16,572,034
in the corresponding nine-month period of the prior fiscal year. The increase
in
net loss in this nine-month period versus the corresponding nine-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 and the increase in general and administrative expenses. Our operating
loss for the nine months ended April 30, 2008 increased to $24,386,455 compared
to $17,464,731 in the corresponding nine-month period ended April 30, 2007.
The
increase resulted from an increase in research and development expenses (to
$11,620,817 from $8,373,393), an increase in selling expense (to $1,070,722
from
$214,089) and increases in general and administrative expenses (to $11,733,562
from $9,003,615). Our net revenues decreased to $64,870 in the nine months
ended
April 30, 2008 from $195,386 in the nine months ended April 30, 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 nine-month period ended
April 30, 2008 reflects an increased level of research and development of our
oral insulin product and platform technology and additional clinical trials
and
increased research and development efforts of Antigen. The increase in general
and administrative expenses reflects the increase in legal, financial,
consulting expenses and an increase in executive compensation due to cash and
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 nine-month period ended April 30, 2008 increased to
$725,535 compared to interest expense of $709,507 in the nine-month period
ended
April 30, 2007 due to interest paid on the secured convertible notes issued
in
March 2008 in connection with a private placement. In the nine-month period
ended April 30, 2008, we did not incur loss on extinguishment of debt reflecting
monthly amortization payments due on the secured convertible notes. In the
nine-month period ended April 30, 2007, our loss on extinguishment of debt
was
$237,162. Our interest income decreased to $958,457 in the nine-month period
ended April 30, 2008 compared to $1,719,169 in the same period in the last
fiscal year primarily due to lower cash and short-term investment balances
during the current nine-month period and substantially lower market interest
rates. We received higher income from rental operations (net of expense) of
$250,195 in the nine months ended April 30, 2008 compared to $120,197 in the
nine months ended April 30, 2007.
Developments
Financing
On
March
31, 2008, we entered into a Securities Purchase Agreement and related documents
with existing institutional investors relating to a private placement of 8%
secured convertible notes (the "Notes") and warrants (the "Warrants”) for
aggregate gross proceeds to us of $20,650,000. In connection with the financing,
we entered into a Registration Rights Agreement under which we filed a
registration statement with the SEC on April 30, 2008 covering the resale of
the
shares of our common stock issuable pursuant to the Notes and Warrants.
Also
in
connection with the financing, Generex and its subsidiaries entered into a
Security Agreement and related documents pledging and granting security
interests to the investors in all of the non-real estate assets of Generex
and
its subsidiaries to secure all of our obligations to the investors, including
our obligations pursuant to the Securities Purchase Agreement and the Notes
and
Warrants issued thereunder. With limited exceptions, the Security Agreement
prohibits us from incurring future debt until the Notes are paid or converted.
An “Event of Default” under the Notes constitutes an “Event of Default” under
the Security Agreement.
The
terms
of the Notes and Warrants are described below under “Financial Condition,
Liquidity and Resources - Secured Convertible Notes and Warrants.”
22
Other
In
March
2008, we initiated the Phase III protocol in North America for Generex
Oral-lynTM,
with
the commencement of patient screening. The first screening took place in late
March in Texas. Other clinical sites participating in the study located in
the
United States are in Texas, Maryland, Minnesota and California, and in Canada
in
the province of Alberta. The first patient dosing is expected to take place
in
early June 2008 in the United States.
In
April
2008, we entered into a product licensing and distribution agreement with and
SciGen, Ltd. under which SciGen will procure governmental approvals for the
importation, marketing, distribution, and sale of Generex Oral-lynTM
in the
People's Republic of China, Hong Kong, and the following additional countries:
Indonesia, South Korea, Malaysia, the Philippines, Singapore, Thailand, and
Vietnam.
Financial
Condition, Liquidity and Resources
To
date
we have financed our development stage activities primarily through private
placements of our common stock and securities convertible into our common
stock.
At
April
30, 2008, we had cash and short-term investments of approximately $36.4 million,
an increase of $1.4 million from the balance as of the end of the prior fiscal
year. As of April 30, 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 examining options for the procurement
of
a reliable long-term 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.
Secured
Convertible Notes and Warrants
At
April
30, 2008, we had 8% secured convertible notes (the “Notes”) outstanding in the
aggregate principal amount of $20,650,000, which were issued in connection
with
the Securities Purchase Agreement dated March 31, 2008. Interest
on the principal amount outstanding under the Notes will accrue at a rate of
eight percent (8%) per
annum.
As of
April 30, 2008, we incurred interest expense of $551,107 related to the Notes.
The
Notes
have an 18-month maturity and amortize over fifteen (15) months in fifteen
(15)
equal monthly installments beginning on August 1, 2008. We may pay installments
of principal and accrued interest in cash or, at our option, in shares of our
common stock subject to the satisfaction of certain conditions. If we elect
to
pay principal and interest in shares of our common stock, the value of each
share of common stock will be equal to the lower of (a) the conversion price,
and (b) 90% of the average of the volume weighted average prices of the common
stock on each of the twenty (20) consecutive trading days immediately preceding
the applicable payment date.
At
the
option of the holder of each Note, the principal amount outstanding under each
Note is convertible at any time after March 31, 2008 into shares of our common
stock at the initial conversion price of $1.21, which represents 110% of the
closing bid price of our common stock on the NASDAQ Capital Market on the
closing date, March 31, 2008.
Each
Note
lists certain “Events of Default”, which include, without limitation, any
default in the payment of principal of, interest on or other charges in respect
of the Notes as and when they become due and payable, and our failure to observe
or perform any other covenant, agreement or warranty contained in, or otherwise
commit any breach or default of any provision of Note, the Securities Purchase
Agreement or the Security Agreement (as described below). Upon the occurrence
of
an Event of Default, the holder may require us to redeem all or any portion
of a
Note by delivering written notice thereof to us, at a default redemption price
as calculated pursuant to certain formulas set forth in the Note. Until the
default redemption price (together with any interest thereon) is paid in full,
the amount of any Note submitted for redemption (together with any interest
thereon) may be converted, in whole or in part, by the holder into common stock.
In the event of a partial redemption, the principal amount redeemed shall be
deducted from the installment amounts relating to the applicable installment
date(s) as set forth in the notice of default and redemption.
23
The
aggregate amount payable upon an Event of Default is the default redemption
price. The default redemption price is calculated as the greater
of:
(i)
the
product of (A) the sum of the principal amount to be redeemed together with
accrued and unpaid interest and unpaid late charges with respect to such
principal amount and (B) 135%, and
(ii)
the
product of
(X)
the
principal
amount of the Notes to be prepaid, plus all other accrued and unpaid interest
thereof, divided by the conversion price on
in
effect at such time as the holder delivers an Event of Default redemption notice
and
(Y)
the
product of (1) the 135% and (2) the greater of (I) the closing sale price of
our
common stock on the date immediately preceding such Event of Default, (II)
the
closing sale price of our common stock on the date immediately after such Event
of Default and (III) the closing sale price of the common stock on the date
the
holder delivers the Event of Default redemption notice.
Beginning
from and after the occurrence of any Event of Default, the interest rate on
the
Notes will accrue at the rate of 16% per annum, or such lower maximum amount
of
interest permitted to be charged under applicable law.
To
date,
we have not issued any shares of common stock resulting from the conversion
and
repayment of any Note principal and accrued interest issued.
The
Warrants issued in connection with the Securities Purchase Agreement dated
March
31, 2008 include:
(i) |
Series
A and A-1 Warrants, which are exercisable for a period of 7 years
into an
aggregate of 75% of the number of shares of our common stock initially
issuable upon conversion of the Notes, with the Series A Warrants
being
exercisable into 5,257,729 shares immediately upon issuance and the
Series
A-1 warrants being exercisable into 7,51,857 shares beginning October
1,
2008;
|
(ii) |
Series
B Warrants, which are exercisable beginning October 1, 2008 into
100% of
the shares of our common stock initially issuable upon conversion
of the
Notes (initially 17,066,166 shares) and remaining exercisable for
a period
of 18 months after a registration statement covering the shares of
common
stock issuable upon conversion or exercise of the Notes and Warrants
is
declared effective by the SEC; and
|
(iii) |
Series
C Warrants, which are exercisable for a period of 7 years beginning
October 1, 2008, but only to the extent that the Series B Warrant
are
exercised and only in the same percentage that the Series B Warrants
are
exercised, up to a maximum percentage of 75% of the number of shares
of
our common stock initially issuable upon conversion of the Notes
(initially a maximum of 12,799,586 shares).
|
The
initial exercise price of each Series A Warrant, Series A-1 Warrant, Series
B
Warrant and Series C Warrant will be $1.21.
In
accordance with the terms of the Notes and the Warrants, no investor may convert
a Note or exercise a Warrant if after giving effect to such conversion or
exercise, as the case may be, such investor would beneficially own greater
than
4.90% or 4.99%, as to certain investors, and 9.90% or 9.99%, as to other
investors, of outstanding shares of our common stock after giving effect to
such
conversion or exercise, as applicable.
We
have
agreed that so long as any Note is outstanding, we will not issue any variable
priced equity or variable priced equity-linked securities. We are also
prohibited from issuing any equity or equity-linked securities until 90 days
after the effective date of the Registration Statement, with limited exceptions.
In addition, until the later of (i) 12 months after the effective date of the
Registration Statement and (ii) the date the Notes have been repaid or converted
in full, the investors will have the right to participate in any capital raising
transactions by Generex.
24
The
conversion price of the Notes and the exercise price of the Warrants are subject
to a full-ratchet adjustment upon the occurrence of certain events, including
the issuance by us of securities at a price per share less than the conversion
price or exercise price then in effect,
as
applicable. If we issue shares of common stock or options exercisable for or
securities convertible into common stock at an effective price per share of
common stock less than the conversion or exercise price then in effect, the
conversion or exercise price will be reduced to the effective price of the
new
issuance.
The
Securities Purchase Agreement provides that unless and until we have obtained
shareholder approval of the issuance of securities pursuant to this transaction,
in no event may we (i) repay the principal amount due and owing under the Notes
with shares of common stock or (ii) issue securities at a price per share less
than the conversion price of the Notes or exercise price of the Warrants. Since
we will be prohibited from issuing common stock or equivalents at a price below
the initial conversion price, and the initial conversion price is based on
110%
of the closing bid price, the conversion price of the Notes and exercise price
of the Warrants cannot decrease below $1.10 which was the closing bid price
on
March 31, 2008. A proposal to approve the issuance of securities pursuant to
this transaction will be voted on at our Annual Meeting scheduled for May 27,
2008.
In
addition, in connection with the transaction, we (a) reduced the strike price
of
our outstanding common stock purchase warrants that are held by the investors
and certain other warrant holders and that have strike prices ranging from
$1.25
to $3.00, to $1.10, which equals the closing bid price of the common stock
on
the NASDAQ Capital Market on the closing date, March 31, 2008, and (b) extended
the expiration date of such warrants to March 31, 2015. The holders of
those warrants will waive all anti-dilution entitlements they have in respect
of
any of our previously issued securities with respect to the issuance or
conversion of the Notes, the payment of the installments or interest in shares
of the common stock, or the issuance or exercise of the Warrants.
At
April
30, 2008, outstanding warrants issued in connection with the Securities Purchase
Agreement dated March 31, 2008 and the repriced warrants described above were
as
follows:
Date
Issued
|
Aggregate
No.
of
Shares Unexercised
|
Exercise
Price*
|
Exercise Date
|
Expiration Date
|
|||||||||
March
31, 2008
|
12,697,024
|
$
|
1.10
|
March 31,
2008
|
March
31, 2015
|
||||||||
March
31, 2008
|
5,257,729
|
$
|
1.21
|
March
31, 2008
|
March
31, 2015
|
||||||||
March
31, 2008
|
20,341,452
|
$
|
1.21
|
October
1, 2008
|
October
1, 2015
|
||||||||
March
31, 2008
|
17,066,108
|
$
|
1.21
|
October
1, 2008
|
October
1, 2009
|
*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:
25
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 April 30, 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
|
3,535,557
|
2,051,316
|
816,757
|
667,484
|
-
|
|||||||||||
Convertible
Debt Obligations
|
22,191,866
|
13,791,447
|
8,400,419
|
-
|
-
|
|||||||||||
Capital
Lease Obligations
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Operating
Lease Obligations
|
493,260
|
151,769
|
220,271
|
121,220
|
-
|
|||||||||||
Purchase
Obligations
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Other
Long-Term Liabilities Reflected on the
Registrant's
Balance Sheet under GAAP
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Total
|
$
|
26,220,683
|
$
|
15,994,532
|
$
|
9,437,447
|
$
|
788,704
|
-
|
26
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.
27
On
December 9, 2005, our Board of Directors approved the grant to Ms. Perri of
a
right of first refusal in respect of any sale, transfer, assignment or other
disposition of either or both real properties municipally known as 1740 Sismet
Road, Mississauga, Ontario and 98 Stafford Drive, Brampton, Ontario
(collectively, the “Properties”). We granted Ms. Perri this right in recognition
of the fair market value transfer to us during the fiscal year ended July 31,
1998 by Ms. Perri (or parties related to her) of the Properties.
We
utilize a management company to manage all of our real properties. The property
management company is owned by Ms. Perri, Ms. Gluskin and the estate of Mark
Perri, our former Chairman of the Board. In the fiscal quarters ended April
30,
2008 and 2007, we paid the management company approximately $13,505 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.
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. In nine month ended April 30, 2008 we paid
approximately $37,000 to Wires Jolley.
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.
Private
Placement of Notes and Warrants.
One of
the institutional investors in the March 2008 private placement of the Notes
and
Warrants was Cranshire Capital, L.P. ("Cranshire"). Cranshire purchased Notes
in
the aggregate principal amount of $5,000,000 and received Series A Warrants
initially exercisable for 1,273,058 shares of common stock, Series A-1 Warrants
initially exercisable for 1,826,115 shares, Series B Warrants initially
exercisable for 4,132,231 and Series C Warrants initially exercisable for
3,099,173. On April 9, 2008, following the closing of the March 2008 private
placement, Cranshire jointly filed a Schedule 13G with Downsview Capital, Inc.
and Mitchell P. Kopin reporting beneficial ownership of more than 5% of our
outstanding shares of common stock. A description of the March 2008 private
placement and the Notes and Warrants is set forth above the heading “Financial
Condition, Liquidity and Resources – Secured Convertible Notes and
Warrants.”
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
April
30, 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.
28
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.
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.
In
March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities,” and Amendment of FASB Statement No. 133. SFAS 161
amends SFAS 133, “Accounting for Derivative Instruments and Hedging Activities,”
to amend and expand the disclosure requirements of SFAS 133 to provide greater
transparency about (i) how and why an entity uses derivative instruments, (ii)
how derivative instruments and related hedge items are accounted for under
SFAS
133 and its related interpretations, and (iii) how derivative instruments and
related hedged items affect an entity’s financial position, results of
operations and cash flows. To meet those objectives, SFAS 161 requires
qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of gains and losses on
derivative instruments and disclosures about credit-risk-related contingent
features in derivative agreements. SFAS 161 is effective for fiscal years and
interim periods beginning after November 15, 2008. Earlier adoption is
encouraged. We are currently evaluating the impact of this statement on our
results of operations or financial position.
29
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
April 30, 2008, we had fixed rate debt totaling $3,242,991. This amount consists
of the following:
Loan
Amount
|
Interest Rate
per Annum |
|||
453,260
|
6.82
|
%
|
||
282,682
|
6.82
|
%
|
||
688,511
|
7.60
|
%
|
||
394,839
|
8.50
|
%
|
||
214,220
|
10
|
%
|
||
1,209,479
|
6.07
|
%
|
||
3,242,991
|
Total
|
These
debt instruments mature from August 2008 through June 2011. As our fixed rate
debt instruments mature, we will likely refinance such debt at the existing
market interest rates which may be more or less than interest rates on the
maturing debt. Since this debt is fixed rate debt, if interest rates were to
increase 100 basis points prior to maturity, there would be no impact on
earnings or cash flows.
We
have
neither issued nor own any long-term debt instruments, or any other financial
instruments, for trading purposes and as to which we would be subject to
material market risks.
Item
4. Controls and Procedures.
Evaluation
of disclosure controls and procedures
Prior
to
the filing of this Quarterly Report on Form 10-Q, an evaluation was performed
under the supervision of and with the participation of our management, including
our Chief Executive Officer and Chief Financial Officer, of the effectiveness
of
our disclosure controls and procedures. Based on the evaluation our Chief
Executive Officer and Chief Financial Officer have concluded that, as of the
end
of the period covered by this Quarterly Report of Form 10-Q, the Company’s
disclosure controls and procedures were effective to ensure that information
required to be disclosed by the Company in reports that it files or submits
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is
recorded, processed, summarized and reported within the time periods specified
in the rules and forms of the SEC and is accumulated and communicated to the
Company’s management, as appropriate, to allow timely decisions regarding
required disclosures.
Changes
in internal control over financial reporting
There
was
no change in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15(d)-15(f) under the Exchange Act) during the period covered
by
this Quarterly Report on Form 10-Q that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
30
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
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, as amended, 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 April 30, 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 $235,903,538 at
April 30, 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.
31
Item.
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
Unregistered
Sales of Equity Securities
In
the
fiscal quarter ended April 30, 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 April 30, 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 of 1933, as amended, 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 April 30, 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.
During
the three months ended April 30, 2008, we issued 22,728 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 April 30, 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.
On
March
28, 2008, in connection with settlement and dismissal of litigation instituted
by Newbridge Securities Corporation, we issued Newbridge Securities Corporation
200,000 shares of our common stock and a five-year warrant to purchase 125,000
restricted shares of our common stock at an exercise price of $3.75 per share.
We issued such securities in reliance on the exemption set forth in Section
4(2)
of the Securities Act. Newbridge Securities Corporation represented to us that
it is an “accredited investor” as such term is defined in Rule 501 of Regulation
D promulgated under the Securities Act. The sales of such securities did not
involve the use of underwriters, and no commissions were paid in connection
therewith.
On
March
31, 2008, we issued 8% secured convertible notes and warrants in a private
placement to certain institutional investors , as described in our Current
Report on Form 8-K filed on April 2, 2008.
32
Issuer
Purchases of Equity Securities
On
March
20, 2008, pursuant to a private transaction, we repurchased 326,255 shares
of
our common stock from a third party at an aggregate purchase price of
USD$378,456,
which amount represented the value of USD$1.16 per share based upon the average
closing price of Generex’s common stock on the NASDAQ Capital Market for the 20
trading days immediately preceding March 20, 2008. We have no obligation to
repurchase any other shares of our common stock from this party.
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.
33
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)
|
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)
|
34
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)
|
35
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)
|
36
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).
|
37
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)
|
4.22.1
|
|
Securities
Purchase Agreement, dated March 31, 2008, 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 April 2, 2008).
|
4.22.2
|
|
Registration
Rights Agreement, dated March 31, 2008, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.7 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on April 2,
2008).
|
4.22.3
|
|
Form
of 8% Secured Convertible Note, as amended issued in connection with
Exhibit 4.22.1 (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Registration Statement on Form S-3 filed on
April 30, 2008)
|
4.22.4
|
|
Form
of Series A Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.3 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008)
|
4.22.5
|
|
Form
of Series A-1 Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008)
|
4.22.6
|
|
Form
of Series B Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008)
|
4.22.7
|
|
Form
of Series C Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.6 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008).
|
4.22.8
|
|
Security
Agreement entered into in connection with Exhibit 4.22.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on April 2, 2008).
|
38
4.22.8
|
|
Guaranty
entered into in connection with Exhibit 4.22.1 (incorporated by reference
to Exhibit 4.9 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on April 2, 2008).
|
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.
|
|
39
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
|
|
|
GENEREX
BIOTECHNOLOGY CORPORATION
(Registrant)
|
|
|
|
|
Date:
June 9, 2008
|
By:
|
/s/ Anna
E. Gluskin
|
|
Anna
E. Gluskin
President
and Chief Executive Officer
|
|
|
|
|
Date:
June 9, 2008
|
By:
|
/s/ Rose
C. Perri
|
|
Rose
C. Perri
Chief
Financial Officer
|
40
Generex
Biotechnology Corporation
Form
10-Q
April
30,
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)
|
41
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)
|
42
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)
|
43
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)
|
44
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)
|
4.22.1
|
|
Securities
Purchase Agreement, dated March 31, 2008, 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 April 2, 2008).
|
4.22.2
|
|
Registration
Rights Agreement, dated March 31, 2008, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.7 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on April 2,
2008).
|
4.22.3
|
|
Form
of 8% Secured Convertible Note, as amended issued in connection with
Exhibit 4.22.1 (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Registration Statement on Form S-3 filed on
April 30, 2008)
|
4.22.4
|
|
Form
of Series A Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.3 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008)
|
4.22.5
|
|
Form
of Series A-1 Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008)
|
4.22.6
|
|
Form
of Series B Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008)
|
4.22.7
|
|
Form
of Series C Warrant, as amended issued in connection with Exhibit
4.22.1
(incorporated by reference to Exhibit 4.6 to Generex Biotechnology
Corporation’s Registration Statement on Form S-3 filed on April 30,
2008)
|
45
4.22.8
|
|
Security
Agreement entered into in connection with Exhibit 4.22.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on April 2, 2008).
|
4.22.8
|
|
Guaranty
entered into in connection with Exhibit 4.22.1 (incorporated by reference
to Exhibit 4.9 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on April 2, 2008).
|
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.
|
|
46