GENEREX BIOTECHNOLOGY CORP - Quarter Report: 2006 October (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT OF 1934
For
the
quarterly period ended October 31, 2006
o
TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934
For
the transition period from _________________ to
________________
COMMISSION
FILE NUMBER: 0-25169
GENEREX
BIOTECHNOLOGY CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware
|
|
98-0178636
|
(State
of other jurisdiction of incorporation
or
organization)
|
|
(IRS
Employer Identification
No.)
|
33
HARBOUR SQUARE, SUITE 202
TORONTO,
ONTARIO
CANADA
M5J 2G2
(Address
of principal executive offices)
416/364-2551
(Registrant's
telephone number, including area code)
Not
applicable
(Former
name, former address and former fiscal year
if
changed since last report)
Indicate
by check mark whether the registrant: (1) has filed all reports required by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for the
past
90 days. x
Yes o
No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨ Accelerated
filer x Non-accelerated
filer ¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
o
Yes
x
No
The
number of outstanding shares of the registrant's common stock, par value $.001,
was 108,149,354 as of December 4, 2006.
GENEREX
BIOTECHNOLOGY CORPORATION
INDEX
PART
I. FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial
Statements.
|
1
|
|
|
(Unaudited)
|
|
Consolidated
Balance Sheets -
|
|
October
31, 2006 and July 31, 2006
|
1
|
|
|
Consolidated
Statements of Operations —
for the
three month
|
|
periods
ended October 31, 2006 and 2005, and cumulative from
|
|
November
2, 1995 to October 31, 2006
|
2
|
|
|
Consolidated
Statements of Cash Flows — For the three month
|
|
periods
ended October 31, 2006 and 2005, and cumulative from
|
|
November
2, 1995 to October 31, 2006
|
3
|
|
|
Notes
to Consolidated Financial Statements
|
4
|
|
|
Item
2. Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
|
|
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
|
21
|
|
|
Item
4. Controls
and Procedures
|
22
|
|
|
PART
II: OTHER INFORMATION
|
|
|
|
Item
1. Legal
Proceedings
|
22
|
Item
1A. Risk
Factors
|
22
|
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
|
23
|
|
|
Item
3. Defaults
Upon Senior Securities
|
25
|
|
|
Item
4. Submission
of Matters to a Vote of Security Holders
|
25
|
|
|
Item
5. Other
Information
|
25
|
|
|
Item
6. Exhibits
|
26
|
|
|
Signatures
|
33
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
BALANCE SHEETS
October
31,
|
July
31,
|
||||||
2006
|
2006
|
||||||
ASSETS
|
|||||||
Current
Assets:
|
|||||||
Cash
and cash equivalents
|
$
|
34,603,817
|
$
|
38,208,493
|
|||
Short-term
investments
|
14,374,721
|
14,372,653
|
|||||
Accounts
receivable
|
129,842
|
—
|
|||||
Inventory
|
18,554
|
—
|
|||||
Other
current assets
|
520,272
|
237,752
|
|||||
Total
Current Assets
|
49,647,206
|
52,818,898
|
|||||
Property
and Equipment, Net
|
2,487,819
|
2,585,744
|
|||||
Assets
Held for Investment, Net
|
3,605,950
|
3,602,773
|
|||||
Patents,
Net
|
5,051,079
|
5,097,827
|
|||||
TOTAL
ASSETS
|
$
|
60,792,054
|
$
|
64,105,242
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
4,847,526
|
$
|
5,444,790
|
|||
Current
maturities of long-term debt
|
77,110
|
428,059
|
|||||
Convertible
Debentures, Net of Debt Discount of $385,418 and
|
|||||||
$608,737
at October 31, 2006 and July 31, 2006, respectively
|
153,044
|
160,494
|
|||||
Total
Current Liabilities
|
5,077,680
|
6,033,343
|
|||||
Long-Term
Debt, Net
|
2,969,254
|
2,608,105
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
Equity:
|
|||||||
Special
Voting Rights Preferred stock, $.001 par value;
|
|||||||
authorized,
issued and outstanding 1,000 shares at
|
|||||||
October
31, 2006 and July 31, 2006
|
1
|
1
|
|||||
Common
stock, $.001 par value; authorized 500,000,000 shares at
|
|||||||
October
31, 2006 and July 31, 2006; 107,990,540 and 107,398,360
|
|||||||
shares
issued and outstanding, respectively
|
107,990
|
107,397
|
|||||
Additional
paid-in capital
|
244,018,721
|
243,097,627
|
|||||
Deficit
accumulated during the development stage
|
(192,153,357
|
)
|
(188,495,312
|
)
|
|||
Accumulated
other comprehensive income
|
771,765
|
754,081
|
|||||
Total
Stockholders’ Equity
|
52,745,120
|
55,463,794
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
60,792,054
|
$
|
64,105,242
|
The Notes to Consolidated Financial Statements are an integral
part of these statements.
1
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
|
Cumulative
From
|
|||||||
|
|
|
November
2, 1995
|
|||||||
|
For
the Three Months Ended
|
(Date
of Inception)
|
||||||||
|
October
31,
|
to
October 31,
|
||||||||
|
2006
|
2005
|
2006
|
|||||||
Revenues
|
$
|
139,005
|
$
|
43,750
|
$
|
2,333,301
|
||||
|
||||||||||
Cost
of Goods Sold
|
31,515
|
—
|
31,515
|
|||||||
|
||||||||||
Operating
Expenses:
|
||||||||||
Research
and development
|
1,592,933
|
676,379
|
62,702,906
|
|||||||
Research
and development -
|
||||||||||
related
party
|
—
|
—
|
220,218
|
|||||||
General
and administrative
|
2,494,739
|
1,474,856
|
80,635,308
|
|||||||
General
and administrative -
|
||||||||||
related
party
|
—
|
—
|
314,328
|
|||||||
Total
Operating Expenses
|
4,087,672
|
2,151,235
|
143,872,760
|
|||||||
|
||||||||||
Operating
Loss
|
(3,980,182
|
)
|
(2,107,485
|
)
|
(141,570,974
|
)
|
||||
|
||||||||||
Other
Income (Expense):
|
||||||||||
Miscellaneous
income (expense)
|
—
|
—
|
196,193
|
|||||||
Income
from Rental Operations, net
|
34,473
|
4,853
|
353,836
|
|||||||
Interest
income
|
603,772
|
1,337
|
4,765,850
|
|||||||
Interest
expense
|
(257,590
|
)
|
(6,739,575
|
)
|
(42,685,966
|
)
|
||||
Loss
on extinguishment of debt
|
(58,518
|
)
|
(162,348
|
)
|
(13,955,424
|
)
|
||||
|
||||||||||
Net
Loss Before Undernoted
|
(3,658,045
|
)
|
(9,003,218
|
)
|
(192,896,485
|
)
|
||||
|
||||||||||
Minority
Interest Share of Loss
|
—
|
—
|
3,038,185
|
|||||||
|
||||||||||
Net
Loss
|
(3,658,045
|
)
|
(9,003,218
|
)
|
(189,858,300
|
)
|
||||
|
||||||||||
Preferred
Stock Dividend
|
—
|
—
|
2,295,057
|
|||||||
|
||||||||||
Net
Loss Available to Common
|
||||||||||
Shareholders
|
$
|
(3,658,045
|
)
|
$
|
(9,003,218
|
)
|
$
|
(192,153,357
|
)
|
|
|
||||||||||
Basic
and Diluted Net Loss Per
|
||||||||||
Common
Share
|
$
|
(.03
|
)
|
$
|
(.20
|
)
|
||||
|
||||||||||
Weighted
Average Number of Shares
|
||||||||||
of
Common Stock Outstanding
|
107,608,541
|
45,798,108
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
2
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Cumulative
From
|
||||||||||
November
2, 1995
|
||||||||||
For
the Three Months Ended
|
(Date
of Inception)
|
|||||||||
October
31,
|
to
October 31,
|
|||||||||
2006
|
2005
|
2006
|
||||||||
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
$
|
(3,658,045
|
)
|
$
|
(9,003,218
|
)
|
$
|
(189,858,300
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
||||||||||
in
operating activities:
|
||||||||||
Depreciation
and amortization
|
288,593
|
279,984
|
5,004,449
|
|||||||
Minority
interest share of loss
|
—
|
—
|
(3,038,185
|
)
|
||||||
Reduction
of notes receivable - common stock in exchange
|
||||||||||
for
services rendered
|
—
|
—
|
423,882
|
|||||||
Write-off
of uncollectible notes receivable - common stock
|
—
|
—
|
391,103
|
|||||||
Write-off
of deferred offering costs
|
—
|
—
|
3,406,196
|
|||||||
Write-off
of abandoned patents
|
3,097
|
1,278
|
152,882
|
|||||||
Loss
on disposal of property and equipment
|
—
|
162,348
|
911
|
|||||||
Loss
on extinguishment of debt
|
58,518
|
—
|
13,955,424
|
|||||||
Common
stock issued as employee compensation
|
183,000
|
—
|
1,728,504
|
|||||||
Common
stock issued for services rendered
|
160,639
|
(27,211
|
)
|
5,461,942
|
||||||
Amortization
of prepaid services in conjunction with common
|
||||||||||
stock
issuance
|
—
|
46,125
|
138,375
|
|||||||
Non-cash
compensation expense
|
—
|
—
|
45,390
|
|||||||
Stock
options and warrants issued for services rendered
|
—
|
—
|
7,006,323
|
|||||||
Issuance
of warrants as additional exercise right inducement
|
—
|
—
|
21,437,909
|
|||||||
Preferred
stock issued for services rendered
|
—
|
—
|
100
|
|||||||
Treasury
stock redeemed for non-performance of services
|
—
|
—
|
(138,000
|
)
|
||||||
Amortization
of deferred debt issuance costs and loan
|
||||||||||
origination
fees
|
—
|
147,630
|
1,482,879
|
|||||||
Amortization
of discount on convertible debentures
|
223,319
|
3,415,992
|
18,545,009
|
|||||||
Common
stock issued as interest payment on convertible
|
||||||||||
debentures
|
10,628
|
3,151,489
|
279,371
|
|||||||
Interest
on short-term advance
|
—
|
6,658
|
30,856
|
|||||||
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
|
(97,691
|
)
|
—
|
(97,691
|
)
|
|||||
Miscellaneous
receivables
|
--
|
—
|
43,812
|
|||||||
Inventory
|
(18,552
|
)
|
—
|
(18,552
|
)
|
|||||
Other
current assets
|
(143,487
|
)
|
5,562
|
(246,132
|
)
|
|||||
Accounts
payable and accrued expenses
|
(601,675
|
)
|
173,525
|
9,035,578
|
||||||
Other,
net
|
—
|
—
|
110,317
|
|||||||
Net
Cash Used in Operating Activities
|
(3,591,656
|
)
|
(1,639,838
|
)
|
(104,248,868
|
)
|
||||
Cash
Flows From Investing Activities:
|
||||||||||
Purchase
of property and equipment
|
(42,496
|
)
|
(13
|
)
|
(4,485,203
|
)
|
||||
Costs
incurred for patents
|
(55,571
|
)
|
(22,795
|
)
|
(1,664,567
|
)
|
||||
Change
in restricted cash
|
—
|
29,295
|
45,872
|
|||||||
Proceeds
from maturity of short term investments
|
7,841,384
|
—
|
143,128,430
|
|||||||
Purchases
of short-term investments
|
(7,843,452
|
)
|
—
|
(157,503,151
|
)
|
|||||
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
|
(170,546
|
)
|
—
|
(677,379
|
)
|
|||||
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
|
(270,681
|
)
|
6,487
|
(24,455,733
|
)
|
|||||
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
|
(18,305
|
)
|
(52,693
|
)
|
(1,797,523
|
)
|
||||
Change
in due to related parties
|
—
|
—
|
154,541
|
|||||||
Proceeds
from exercise of warrants
|
125,000
|
6,391,999
|
44,015,049
|
|||||||
Proceeds
from exercise of stock options
|
153,133
|
101,545
|
4,405,328
|
|||||||
Proceeds
from minority interest investment
|
—
|
—
|
3,038,185
|
|||||||
Proceeds
from issuance of preferred stock
|
—
|
—
|
12,015,000
|
|||||||
Proceeds
from issuance of convertible debentures, net
|
—
|
2,485,000
|
20,254,930
|
|||||||
Repayments
of convertible debentures
|
—
|
—
|
(461,358
|
)
|
||||||
Purchase
of treasury stock
|
—
|
—
|
(119,066
|
)
|
||||||
Proceeds
from issuance of common stock, net
|
—
|
—
|
80,283,719
|
|||||||
Purchase
and retirement of common stock
|
—
|
—
|
(483,869
|
)
|
||||||
Net
Cash Provided by Financing Activities
|
259,828
|
8,925,851
|
163,288,355
|
|||||||
Effect
of Exchange Rates on Cash
|
(2,167
|
)
|
1,051
|
20,063
|
||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(3,604,676
|
)
|
7,293,551
|
34,603,817
|
||||||
Cash
and Cash Equivalents, Beginning of Period
|
38,208,493
|
586,530
|
—
|
|||||||
Cash
and Cash Equivalents, End of Period
|
$
|
34,603,817
|
$
|
7,880,081
|
$
|
34,603,817
|
The
Notes to Consolidated Financial Statements are an
integral part of these statements.
3
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. |
Basis
of Presentation
|
The
accompanying unaudited interim consolidated financial statements have been
prepared pursuant to the rules and regulations for reporting on Form 10-Q.
Accordingly, certain information and disclosures required by generally accepted
accounting principles for complete financial statements are not included herein.
The interim statements should be read in conjunction with the financial
statements and notes thereto included in the Company’s latest Annual Report on
Form 10-K. The results for the three months may not be indicative of the results
for the entire year.
Interim
statements are subject to possible adjustments in connection with the annual
audit of the Company’s accounts for the fiscal year 2007. In the Company’s
opinion all adjustments necessary for a fair presentation of these interim
statements have been included and are of a normal and recurring
nature.
The
Company is in the development stage and has realized minimal revenues to date.
The Company currently has one approved product, Glucose RapidSpray, which has
generated revenue commencing during the three months ended October 31, 2006.
The
Company will continue to require substantial funds to continue research and
development, including preclinical studies and clinical trials of its product
candidates, and to commence sales and marketing efforts if the FDA or other
regulatory approvals are obtained. Management’s plans in order to meet its
operating cash flow requirements include financing activities such as private
placement of its common stock, preferred stock offerings and offerings of debt
and convertible debt instruments. Management is also actively pursuing industry
collaboration activities including product licensing and specific project
financing.
While
the
Company believes that it will be successful in obtaining the necessary financing
to fund its operations, there are no assurances that such additional funding
will be achieved and that it will succeed in its future operations. The
financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or amounts of
liabilities that might be necessary should the Company be unable to continue
in
existence.
2. |
Summary
of Significant Accounting
Policies
|
Accounts
Receivable
Accounts
receivable are customer obligations due under normal trade terms. The Company
sells its product to various pharmacies. The Company performs ongoing credit
evaluations of customers’ financial condition and does not require collateral.
Management
reviews accounts receivable on a monthly basis to determine collectibility.
Balances that are determined to be uncollectible are written off to the
allowance for doubtful accounts. The allowance for doubtful accounts contains
a
general accrual for estimated bad debts and had a balance of $-0- and at October
31, 2006 and July 31, 2006, however, actual write-offs may exceed the
allowance.
Inventory
Inventories
consist primarily of Glucose RapidSpray product and components. Inventories
are
stated at the lower of cost or market with cost determined using the first-in
first-out (“FIFO”) method. In evaluating whether inventory is stated at the
lower of cost or market, management considers such factors as the amount of
inventory on hand and in the distribution channel, estimated time required
to
sell such inventory, remaining shelf life and current and expected market
conditions, including levels of competition. As appropriate, a provision is
recorded to reduce inventories to their net realizable value.
4
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Revenue
Recognition
Revenues
are recognized when the following fundamental criteria are met: (i) persuasive
evidence of an arrangement exists; (ii) delivery has occurred; (iii) the price
to the customer is fixed or determinable; and (iv) collection of the sales
price
is reasonably assured. Delivery occurs when goods are shipped and title and
risk
of loss transfer to the customer, in accordance with the terms specified in
the
arrangement with the customer. Revenue recognition is deferred in all instances
where the earnings process is incomplete. Certain product sales are made to
retailers under agreements allowing for a right to return unsold products.
Recognition of revenue on all sales to these retailers is deferred until a
provision for returns can be reasonably estimated based on historical
experience or the products are sold to a third party.
3. |
Effects
of Recent Accounting
Pronouncements
|
In
March
2006, the FASB issued SFAS No. 156, “Accounting for Servicing of Financial
Assets”, to simplify accounting for separately recognized servicing assets and
servicing liabilities. SFAS No. 156 amends SFAS No. 140, “Accounting for
Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.
Additionally, SFAS No. 156 permits, but does not require, an entity to choose
either the amortization method or the fair value measurement method for
measuring each class of separately recognized servicing assets and servicing
liabilities. SFAS No. 156 applies to all separately recognized servicing assets
and servicing liabilities acquired of issued after the beginning of an entity’s
fiscal year that begins after September 15, 2006, although early adoption is
permitted. The
Company does not expect that the adoption of SFAS No. 156 will have a
significant impact on the consolidated results of operations or financial
position of the Company.
In
July
2006, FASB has published FASB Interpretation No. 48 (FIN No. 48), “Accounting
for Uncertainty in Income Taxes”, to address the noncomparability in reporting
tax assets and liabilities resulting from a lack of specific guidance in SFAS
No. 109, “Accounting for Income Taxes”, on the uncertainty in income taxes
recognized in an enterprise’s financial statements. FIN No. 48 will apply
to fiscal years beginning after December 15, 2006, with earlier adoption
permitted. The
Company does not expect that the adoption of FIN No. 48 will have a significant
impact on the consolidated results of operations or financial position of the
Company.
5
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,”
to
eliminate the diversity in practice that exists due to the different definitions
of fair value and the limited guidance for applying those definitions in GAAP
that are dispersed among the many accounting pronouncements that require fair
value measurements. SFAS No. 157 retains the exchange price notion in earlier
definitions of fair value, but clarifies that the exchange price is the price
in
an orderly transaction between market participants to sell an asset or liability
in the principal or most advantageous market for the asset or liability.
Moreover, the SFAS states that the transaction is hypothetical at the
measurement date, considered from the perspective of the market participant
who
holds the asset or liability. Consequently, fair value is defined as the price
that would be received to sell an asset or paid to transfer a liability in
an
orderly transaction between market participants at the measurement date (an
exit
price), as opposed to the price that would be paid to acquire the asset or
received to assume the liability at the measurement date (an entry
price).
SFAS
No.
157 also stipulates that, as a market-based measurement, fair value measurement
should be determined based on the assumptions that market participants would
use
in pricing the asset or liability, and establishes a fair value hierarchy that
distinguishes between (a) market participant assumptions developed based on
market data obtained from sources independent of the reporting entity
(observable inputs) and (b) the reporting entity's own assumptions about market
participant assumptions developed based on the best information available in
the
circumstances (unobservable inputs). Finally, SFAS No. 157 expands disclosures
about the use of fair value to measure assets and liabilities in interim and
annual periods subsequent to initial recognition. Entities are encouraged to
combine the fair value information disclosed under SFAS No. 157 with the fair
value information disclosed under other accounting pronouncements, including
SFAS
No.
107,
“Disclosures about Fair Value of Financial Instruments,” where practicable. The
guidance in this Statement applies for derivatives and other financial
instruments measured at fair value under
SFAS
No.
133,
“Accounting for Derivative Instruments and Hedging Activities,” at initial
recognition and in all subsequent periods.
SFAS
No.
157 is effective for financial statements issued for fiscal years beginning
after November 15, 2007, and interim periods within those fiscal years, although
earlier application is encouraged. Additionally, prospective application of
the
provisions of SFAS No. 157 is required as of the beginning of the fiscal year
in
which it is initially applied, except when certain circumstances require
retrospective application. The Company is currently evaluating the impact of
this statement on its results of operations or financial position of the
Company.
In
September 2006, the FASB issued “Statement of Financial Accounting Standards No.
158, Employers’ Accounting for Defined Benefit Pension and Other Postretirement
Plans (an amendment of FASB Statements No. 87, 88, 106, and 132R)”, which will
require employers to fully recognize the obligations associated with
single-employer defined benefit pension, retiree healthcare and other
postretirement plans in their financial statements. Under past accounting
standards, the funded status of an employer’s postretirement benefit plan (i.e.,
the difference between the plan assets and obligations) was not always
completely reported in the balance sheet. Past standards only required an
employer to disclose the complete funded status of its plans in the notes to
the
financial statements. SFAS No. 158 applies to plan sponsors that are public
and
private companies and nongovernmental not-for-profit organizations. The
requirement to recognize the funded status of a benefit plan and the disclosure
requirements are effective as of the end of the fiscal year ending after
December 15, 2006, for entities with publicly traded equity securities, and
at
the end of the fiscal year ending after June 15, 2007, for all other entities.
The requirement to measure plan assets and benefit obligations as of the date
of
the employer’s fiscal year-end statement of financial position is effective for
fiscal years ending after December 15, 2008. The Company does not expect that
the adoption of SFAS No. 158 will have a significant impact on the consolidated
results of operations or financial position of the Company.
6
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
4. |
Stock-Based
Compensation
|
As
of
October 31, 2006, the Company had two stockholder-approved stock incentive
plans
under which options exercisable for shares of common stock have been or may
be
granted to employees, directors, consultants and advisors. A total of 2,000,000
shares of common stock are reserved for issuance under the 2000 Stock Option
Plan (the 2000 Plan) and a total of 12,000,000 shares of common stock are
reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan). There
were 1,900,000 and 1,222,331 shares of common stock reserved for future awards
under the 2000 Plan and 2001 Plan, respectively, as of October 31,
2006.
The
2000
and 2001 Plans (the Plans) are administered by the Compensation Committee (the
Committee). The Committee is authorized to select from among eligible employees,
directors, advisors and consultants those individuals to whom options are to
be
granted and to determine the number of shares to be subject to, and the terms
and conditions of the options. The Committee is also authorized to prescribe,
amend and rescind terms relating to options granted under the Plans. Generally,
the interpretation and construction of any provision of the Plans or any options
granted hereunder is within the discretion of the Committee.
The
Plans
provide that options may or may not be Incentive Stock Options (ISOs) within
the
meaning of Section 422 of the Internal Revenue Code. Only employees of the
Company are eligible to receive ISOs, while employees and non-employee
directors, advisors and consultants are eligible to receive options which are
not ISOs, i.e. “Non-Qualified Options.” The options granted by the Board in
connection with its adoption of the Plans are Non-Qualified
Options.
The
following information relates to stock options that have been granted under
the
Company’s stockholder-approved incentive plans. The stock option exercise price
is typically granted at 100 percent of the fair market value on the date the
options are granted. Options may be exercised for a period of five years
commencing on the date of grant and typically vesting over two years from the
date of grant.
The
fair
value of each option award is estimated on the date of grant using the
Black-Scholes option pricing model. No options were granted to employees during
the three months ended October 31, 2006.
The
summary of the stock option activity for the three months ended October 31,
2006
is as follows:
Weighted
|
Weighted
|
||||||||||||
Average
|
Average
|
||||||||||||
Exercise
|
Remaining
|
Aggregate
|
|||||||||||
Price
|
Contractual
|
Instrinsic
|
|||||||||||
Shares
|
Share
|
Term
(Years)
|
Value
|
||||||||||
Outstanding,
August 1, 2006
|
8,429,597
|
$
|
1.15
|
||||||||||
Granted
|
—
|
$
|
—
|
||||||||||
Cancelled
|
(180,000
) $
|
8.12
|
|||||||||||
Exercised
|
(96,800
|
)
|
$
|
1.58
|
|||||||||
Outstanding,
October 31, 2006
|
8,152,797
|
$
|
0.99
|
2.58
|
$
|
8,640,721
|
|||||||
Exercisable,
October 31, 2006
|
8,152,797
|
$
|
0.99
|
2.58
|
$
|
8,640,721
|
|||||||
Grant
Date Fair of Cancelled Options
|
$
|
5.88
|
|||||||||||
Total
Intrinsic Value of Options Exercised
|
$
|
39,500
|
7
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company had no non-vested stock options outstanding as of October 31, 2006
and
July 31, 2006. Accordingly, there was no unrecognized compensation related
to
non-vested stock options granted under the Company’s stock option
plans.
5. |
Comprehensive
Income/(Loss)
|
Comprehensive
loss, which includes net loss and the change in the foreign currency translation
account during the period, for the three months ended October 31, 2006 and
2005,
was $3,640,361 and $8,914,561, respectively.
6. |
Accounts
Payable and Accrued
Expenses
|
Accounts
payable and accrued expenses consist of the following:
October
30,
|
July
31,
|
||||||
2006
|
2006
|
||||||
Accounts
Payable
|
$
|
1,470,200
|
$
|
624,543
|
|||
Research
and Development
|
368,933
|
696,769
|
|||||
Executive
Compensation
|
1,596,455
|
2,121,389
|
|||||
Financial
Services
|
1,411,938
|
1,411,938
|
|||||
Total
|
$
|
4,847,526
|
$
|
5,444,790
|
8
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
7. |
Convertible
Debentures
|
The
convertible debentures are accounted for in accordance with EITF 98-5 and 00-27.
The following summarizes the significant terms and accounting for each
convertible debenture entered into by the Company.
Debenture
|
||||
3rd
$4,000,000
|
||||
Date
Issued
|
2/2006 | |||
Promissory
Note Amount
|
$
|
1,000,000
|
||
#
of Promissory Notes
|
4 | |||
Terms
|
(A | ) | ||
Conversion
Price
|
$
|
1.25
|
||
Gross
Proceeds
|
$
|
4,000,000
|
||
Net
Cash Proceeds
|
$
|
4,000,000
|
||
Warrants
Issued to Investor
|
3,200,000 | |||
Warrant
Exercise Price
|
$
|
1.25
|
||
Warrant
Fair Value (WFV)
|
$
|
2,374,507
|
||
Black
Scholes Model Assumptions
|
(B1 | ) | ||
Beneficial
Conversion Feature (BCF)
|
$
|
1,625,493
|
||
Amortization
of WFV and BCF as
|
||||
Non-cash
Interest Expense
|
$
|
3,614,582
|
||
Principal
and Interest Converted
|
$
|
2,850,739
|
||
Loss
on Extinguishment (C)
|
$
|
2,373,363
|
||
Shares
Issued Upon Conversion
|
2,280,592 | |||
Principal
and Interest Repayments
|
||||
in
Shares of Common Stock
|
$
|
680,684
|
||
Loss
on Extinguishment (C)
|
$
|
470,075
|
||
Shares
Issued for Principal and
|
||||
Interest
Repayments
|
514,665 | |||
Principal
and Interest Repayments
|
||||
in
Cash
|
$
|
—
|
As
of
October 31, 2006, the $153,044 net outstanding balance of convertible debentures
is comprised of $538,462 of debt net of unamortized debt discount of $385,418
related to the 3rd
$4,000,000 convertible debentures. All other convertible debentures have either
been repaid or converted to shares of common stock and the related debt
discounts have been fully amortized.
(A) |
The
notes carry a 6% coupon and a 15-month term and amortization in 13
equal
assignments commencing in the third month of the term. The principal
and
interest payments are payable in cash or, at the Company's option,
the
lesser of registered stock valued at a 10% discount to the average
of the
20-day VWAP as of the payment date or predetermined conversion price,
subject to certain conditions.
|
(B) |
Black
Scholes pricing model assumptions:
|
Risk
Free
|
Expected
|
||||||
Interest
Rate
|
Volatility
|
Life
(Years)
|
|||||
4.49%
|
0.9380
|
5.50
|
9
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(C) |
Loss
on extinguishment represents the difference between the quoted market
price of the Company's common stock and lower of predetermined conversion
price or the 10% discount to the average of the 20-day
VWAP.
|
8. |
Pending
Litigation
|
In
February 2001, a former business associate of the former Vice President of
Research and Development (VP), and an entity called Centrum Technologies Inc.
(“CTI”) commenced an action in the Ontario Superior Court of Justice against the
Company and the VP seeking, among other things, damages for alleged breaches
of
contract and tortious acts related to a business relationship between this
former associate and the VP that ceased in July 1996. The plaintiffs’ statement
of claim also seeks to enjoin the use, if any, by the Company of three patents
allegedly owned by the company called CTI. On July 20, 2001, the Company filed
a
preliminary motion to dismiss the action of CTI as a nonexistent entity or,
alternatively, to stay such action on the grounds of want of authority of such
entity to commence the action. The plaintiffs brought a cross motion to amend
the statement of claim to substitute Centrum Biotechnologies, Inc. (“CBI”) for
CTI. CBI is a corporation of which 50 percent of the shares are owned by the
former business associate and the remaining 50 percent are owned by the Company.
Consequently, the shareholders of CBI are in a deadlock. The court granted
the
Company’s motion to dismiss the action of CTI and denied the plaintiffs’ cross
motion without prejudice to the former business associate to seek leave to
bring
a derivative action in the name of or on behalf of CBI. The former business
associate subsequently filed an application with the Ontario Superior Court
of
Justice for an order granting him leave to file an action in the name of and
on
behalf of CBI against the VP and the Company. The Company opposed the
application. In September 2003, the Ontario Superior Court of Justice granted
the request and issued an order giving the former business associate leave
to
file an action in the name of and on behalf of CBI against the VP and the
Company. A statement of claim was served in July 2004. The Company is not able
to predict the ultimate outcome of this legal proceeding at the present time
or
to estimate an amount or range of potential loss, if any, from this legal
proceeding.
In
September, 2006, The Shemano Group, Inc. (“Shemano”), a San Francisco-based
investment banking firm, commenced an arbitration proceeding against the Company
before the National Association of Securities Dealers (the “NASD”) alleging
entitlements to cash and warrant compensation under a November 1, 2004 finder’s
agreement in respect of certain subsequent financing transactions concluded
by
the Company. The Company has since filed an answer with the NASD. The Company
is
not able to predict the ultimate outcome of this legal proceeding at the present
time.
10
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
Company is involved in certain other legal proceedings in addition to those
specifically described herein. Subject to the uncertainty inherent in all
litigation, the Company does not believe at the present time that the resolution
of any of these legal proceedings is likely to have a material adverse effect
on
the Company’s financial position, operations or cash flows.
With
respect to all litigation, as additional information concerning the estimates
used by the Company becomes known, the Company reassesses its position both
with
respect to accrued liabilities and other potential exposures.
9. |
Net
Loss Per Share
|
Basic
EPS
and Diluted EPS for the three months ended October 31, 2006 and 2005 have been
computed by dividing the net loss for each respective period by the weighted
average number of shares outstanding during that period. All outstanding
warrants and options, approximately 23,894,549 and 29,821,353 incremental shares
at October 31, 2006 and 2005, respectively, have been excluded from the
computation of Diluted EPS as they are anti-dilutive.
10. |
Supplemental
Disclosure of Cash Flow
Information
|
For
the Three Months Ended
|
|||||||
October
31,
|
|||||||
2006
|
2005
|
||||||
Cash
paid during the period for:
|
|||||||
Interest
|
$
|
56,265
|
$
|
56,427
|
|||
Income
taxes
|
$
|
—
|
$
|
—
|
|||
Disclosure
of non-cash investing and financing activities:
|
|||||||
Value
of common stock issued in conjunction with capitalized
|
|||||||
services
upon issuance of convertible debentures
|
$
|
—
|
$
|
140,000
|
|||
Value
of warrants issued in conjunction with capitalized
|
|||||||
services
upon issuance of convertible debentures
|
$
|
—
|
$
|
44,850
|
|||
Increase
in deferred debt issuance costs included in accounts
|
|||||||
payable
and accrued expenses in conjunction with capitalized
|
|||||||
services
upon issuance of convertible debentures
|
—
|
$
|
35,000
|
||||
Costs
paid from proceeds in conjunction with capitalized
|
|||||||
services
upon issuance of convertible debentures
|
$
|
—
|
$
|
15,000
|
|||
Value
of warrants issued in conjunction with issuance of
|
|||||||
convertible
debentures and related beneficial conversion
|
|||||||
feature
|
$
|
—
|
$
|
2,470,370
|
|||
Satisfaction
of accounts payable through the issuance of
|
|||||||
common
stock
|
$
|
—
|
$
|
133,605
|
|||
Principal
repayment of convertible debentures through the
|
|||||||
issuance
of common stock
|
$
|
—
|
$
|
782,308
|
|||
Issuance
of common stock in conjunction with convertible
|
|||||||
debenture
repayments
|
$
|
230,769
|
$
|
—
|
|||
Issuance
of common stock in conjunction with convertible
|
|||||||
debenture
conversion
|
$
|
—
|
$
|
3,685,217
|
|||
Increase
in subscription receivable as a result of warrant
|
|||||||
exercises
|
$
|
—
|
$
|
500,000
|
|||
Increase
in other current assets for the prepayment of services
|
|
||||||
through
the issuance of common stock
|
$
|
—
|
$
|
184,500
|
11
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
11. |
Stockholders’
Equity
|
During
the three months ended October 31, 2006, the Company issued an aggregate of
193,118 shares of common stock as monthly principal and interest payments
totaling $299,915 of convertible debentures (see Note 7).
During
the three months ended October 31, 2006, the Company issued 102,262 shares
of
common stock to various consultants for services rendered in the amount of
$160,639. The shares were valued at $1.43 to $1.83 per share based on the quoted
market price of the Company’s common stock on the dates of the
issuances.
During
the three months ended October 31, 2006, the Company issued 100,000 shares
of
common stock valued at $183,000 as employee compensation based on the quoted
market price of the Company’s common stock on the dates of the
issuances.
During
the three months ended October 31, 2006, the Company received aggregate cash
proceeds of $153,132 from exercises of stock options. The Company issued 96,800
shares of common stock as a result of these transactions.
During
the three months ended October 31, 2006, the Company received aggregate cash
proceeds of $125,000 from exercises of stock warrants. The Company issued
100,000 shares of common stock as a result of these transactions.
The
issuances of common stock as described above are summarized as
follow:
Additional
|
Total
|
||||||||||||
Common
Stock
|
Paid-In
|
Stockholders’
|
|||||||||||
Shares
|
Amount
|
Capital
|
Equity
|
||||||||||
Convertible
Debenture Monthly
|
|||||||||||||
Repayments
|
193,118
|
$
|
193
|
$
|
299,722
|
$
|
299,915
|
||||||
Warrants
and Stock Options Exercised for Cash
|
196,800
|
197 | 277,935 |
278,132
|
|||||||||
Issuance
for Services
|
102,262
|
102 | 160,537 |
160,639
|
|||||||||
Issuance
as Employee Compensation
|
100,000
|
100 | 182,900 |
183,000
|
|||||||||
Total
|
592,180
|
$
|
592
|
$
|
921,094
|
$ |
921,686
|
12
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
As
used
herein, the terms the “Company,” “Generex,” “we,” “us,” or “our” refer to
Generex Biotechnology Corporation, a Delaware corporation. The following
discussion and analysis by management provides information with respect to
our
financial condition and results of operations for the three month period ended
October 31, 2006. This discussion should be read in conjunction with the
information contained in Part
I, Item 1A - Risk Factors
and
Part
II, Item 8 - Financial Statements and Supplementary Data
in our
Annual Report on Form 10-K for the year ended July 31, 2006, and the information
contained in Part
I, Item 1 - Financial Statements
and
Part
II, Item 1A- Risk Factors in
this
Quarterly Report on Form 10-Q for the fiscal quarter ended October 31,
2006.
Forward-Looking
Statements
We
have
made statements in this Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
and
elsewhere in this Quarterly Report on Form 10-Q of Generex Biotechnology
Corporation for the fiscal quarter ended October 31, 2006 that may constitute
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 (the "Act"). The Act limits our liability in
any
lawsuit based on forward-looking statements that we have made. All statements,
other than statements of historical facts, included in this Quarterly Report
that address activities, events or developments that we expect or anticipate
will or may occur in the future, including such matters as our projections,
future capital expenditures, business strategy, competitive strengths, goals,
expansion, market and industry developments and the growth of our businesses
and
operations, are forward-looking statements. These statements can be identified
by introductory words such as "expects," "plans," "intends," "believes," "will,"
"estimates," “anticipates,” "projects," “predicts,” “foresees” or words of
similar meaning, and by the fact that they do not relate strictly to historical
or current facts. Our forward-looking statements address, among other
things:
|
·
|
our
expectations concerning product candidates for our
technologies;
|
|
·
|
our
expectations concerning existing or potential development and license
agreements for third-party collaborations and joint
ventures;
|
|
·
|
our
expectations of when different phases of clinical activity may commence
and conclude;
|
|
·
|
our
expectations of when regulatory submissions may be filed or when
regulatory approvals may be received; and
|
|
·
|
our
expectations of when commercial sales of our products may commence
and
when actual revenue from the product sales may be
received.
|
Any
or
all of our forward-looking statements may turn out to be wrong. They may be
affected by inaccurate assumptions that we might make or by known or unknown
risks and uncertainties. Actual outcomes and results may differ materially
from
what is expressed or implied in our forward-looking statements. Among the
factors that could affect future results are:
|
·
|
the
inherent uncertainties of product development based on our new and
as yet
not fully proven technologies;
|
|
·
|
the
risks and uncertainties regarding the actual effect on humans of
seemingly
safe and efficacious formulations and treatments when tested
clinically;
|
|
·
|
the
inherent uncertainties associated with clinical trials of product
candidates;
|
|
·
|
the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product candidates;
|
|
·
|
the
inherent uncertainties associated with commercialization of products
that
have received regulatory approval; and
|
|
·
|
our
ability to obtain the necessary financing to fund our
operations.
|
Additional
factors that could affect future results are set forth in Part
I, Item 1A Risk Factors
of our
Annual Report on Form 10-K for the year ended July 31, 2006 and in Part
II, Item 1A. Risk Factors
of this
Quarterly Report on Form 10-Q. We caution investors that the forward-looking
statements contained in this Quarterly Report must be interpreted and understood
in light of conditions and circumstances that exist as of the date of this
Quarterly Report. We expressly disclaim any obligation or undertaking to update
or revise forward-looking statements to reflect any changes in management's
expectations resulting from future events or changes in the conditions or
circumstances upon which such expectations are based.
13
Executive
Summary
About
the Company
We
are
engaged primarily in the research, development, and commercialization of drug
delivery systems and technologies. Our primary focus at the present time is
our
proprietary technology for the administration of formulations of large molecule
drugs to the oral (buccal) cavity. In our wholly-owned subsidiary, Antigen
Express, Inc., we focus on immunomedicines. We operate in only one segment:
the
research, development and commercialization of drug delivery systems and
technologies for metabolic and immunological diseases.
We
are a
development stage company and, from inception through the end of the 2006 fiscal
year, had not received any revenues from operations other than the $1,000,000
upfront payment which we received from Eli Lilly and Company pursuant to a
development and license agreement that we entered into in September 2000 and
subsequently terminated as of June 2003. In the quarterly period ended October
31, 2006, we realized revenue of approximately $95,000 from sales of our
confectionary, Glucose RapidSpray™, which we introduced in August 2006 and which
is currently available in certain independent pharmacies in the United States
and Canada. In September 2006, we entered into wholesale purchase agreement
with
Cardinal Health for the distribution of Glucose RapidSpray™ in retail stores
across United States. We subsequently entered into distribution agreements
with
AmerisourceBergen Corporation and McKesson Canada and received purchase orders
from Shoppers Drug Mart. We expect to procure additional distribution
arrangements with wholesalers and retail chains to distribute this product
in
other stores throughout the United States and Canada.
We
have
begun the regulatory approval process for five products: our oral insulin
formulation (late-stage), our oral morphine formulation (pre-clinical), the
Antigen HER-2/neu positive breast cancer vaccine (Phase 2), the Antigen avian
influenza vaccine (Phase 1), and the Antigen prostate cancer vaccine (Phase
1).
Our oral insulin formulation, Generex Oral-lyn™, was approved for commercial
marketing and sale in Ecuador in May 2005 and is presently available for sale
there. Our joint partner for the commercialization of Generex Oral-lyn™ in Latin
America, PharmaBrand S.A., has reported commercial sales of Generex Oral-lyn™ in
Ecuador and expects additional commercial manufacturing runs of the product
at
its facilities in Quito, Ecuador in early 2007. We expect to receive the
revenues from the sale of Generex Oral-lyn™ in Ecuador in the second quarter of
this fiscal year.
Our
organizational structure consists of Generex Biotechnology Corporation and
five
wholly-owned subsidiaries: Generex Pharmaceuticals Inc., which is incorporated
in Ontario, Canada and which performs all of our Canadian operations; Generex
(Bermuda), Inc., which is incorporated in Bermuda and which currently does
not
conduct any business activities; Antigen Express, Inc., which is incorporated
in
Delaware and which we acquired in 2003; Generex Pharmaceuticals (USA) LLC,
which
we organized in North Carolina in February 2006 and which has not yet commenced
any business operations; and Generex Marketing & Distribution Inc., which we
organized in Ontario, Canada in September 2006 and which has not yet commenced
any business operations.
Strategy
With
the
launch of commercial sales of our oral insulin product in Ecuador and our oral
glucose product in independent pharmacies in the United States and Canada,
we
will receive revenues from product sales in the 2007 fiscal year. We project
that this revenue will not be sufficient for all of our cash needs during the
year. In the past, we were able to fund Antigen expenses with some revenue
from
research grants for Antigen's immunomedicine products. During the fiscal quarter
ended October 31, 2006, we received a total of $43,750 in such research grants,
and we have received a total of $1,238,046 in such research grants. We do not
expect to receive such grants on a going forward basis.
We
expect
to satisfy the majority of our cash needs during the current year from previous
capital raised through equity and debt financings with a limited group of
investors. We believe that the terms of such financings were favorable to us.
Through the financing transactions that we closed in our last two fiscal years,
we believe that we have secured the funds necessary to continue with the
commercialization of Generex Oral-lyn™ in Ecuador, to seek regulatory approval
for this product in certain other Latin American countries and to pursue
late-stage clinical trials of this product in Canada and Europe. We also project
that we will have the funds to support further research and development and
clinical testing of the Antigen Express vaccine technologies.
In
fiscal
2007, we plan to continue with the commercialization of Generex Oral-lyn™ in
Ecuador and efforts to obtain regulatory approval of this product in other
Latin
American countries, Canada, and Europe. In September 2006 a Clinical Trial
Application relating to our Generex Oral-lyn™ protocol for late-stage trials was
approved by Health Canada. We anticipate being in a position to commence
late-stage clinical trials of Generex Oral-lyn™ in Canada by the spring of 2007.
In anticipation of undertaking late-stage clinical trials in Canada, we have
secured a manufacturer to produce clinical trial batches of Generex Oral-lyn™.
14
We
face
competition from other providers of alternate forms of insulin, including Pfizer
which could capture a large portion of the market with its inhalable form of
insulin, marketed as Exubera®, initial supplies of which became available in the
U.S. in September 2006. We understand that an expanded roll-out of Exubera® to
primary-care physicians in the U.S., which Pfizer previously targeted for
November 2006, will begin in January 2007. We believe that our buccal delivery
technology offers several advantages over alternate forms of
insulin.
In
fiscal
2007, we expect to continue collaborations to develop other products. We will
continue joint development activities with Fertin Pharma A/S with respect to
a
metformin medicinal chewing gum for the treatment of Type-2 diabetes mellitus
and obesity. We expect to continue clinical development of Antigen’s synthetic
peptide vaccines designed to stimulate a potent and specific immune response
against tumors expressing the HER-2/neu oncogene for patients with stage II
HER-2/neu positive breast cancer and patients with prostate cancer and against
avian influenza.
Accounting
for Research and Development Projects
Our
major
research and development projects are the refinement of our platform buccal
delivery technology, our buccal insulin project (Generex Oral-lyn™), our buccal
morphine product and Antigen’s peptide immunotherapeutic vaccines.
During
the last fiscal quarter, we expended resources on the clinical testing and
commercialization, of our buccal insulin product, Generex Oral-lyn™. We filed a
Clinical Trial Application with Health Canada for the commencement of late-stage
trials for Generex Oral-lyn™, which application was approved by Health Canada in
September, 2006. 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, Europe 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. Our South American joint venture partner, PharmaBrand
S.A.,
completed the first commercial production run of Generex Oral-lyn™ in Ecuador in
June, 2006. During the last fiscal quarter, we and PharmaBrand have implemented
education, marketing and training programs for physicians in Ecuador to support
sales of Generex Oral-lyn™, which is available through physician referrals and
pharmacies. While we anticipate generating revenue from sales of Generex
Oral-lyn™ in Ecuador in fiscal 2007, we do not expect that such revenues will be
sufficient to sustain our research and development and regulatory activities
in
Latin America.
Although
we initiated regulatory approval process for our morphine buccal product, we
did
not expend resources to further this product during our last fiscal
quarter.
During
the last fiscal quarter, we expended resources on research and development
relating to Antigen’s peptide immunotherapeutic vaccines and related
technologies. One Antigen vaccine is currently in Phase 2 clinical trials
involving patients with HER-2/neu positive breast cancer. We expect to begin
clinical trials in Greece in the second quarter of fiscal 2007 with the same
compound as an immunotherapeutic vaccine for prostate cancer. We also expect
to
initiate clinical trials of a synthetic immunotherapeutic vaccine for avian
influenza in Lebanon in fiscal 2007.
Because
of various uncertainties, we cannot predict the timing of completion and
commercialization of our buccal insulin or buccal morphine products or Antigen’s
peptide immunotherapeutic vaccines or related technologies. These uncertainties
include the success of current studies, our ability to obtain the required
financing and the time required to obtain regulatory approval even if our
research and development efforts are completed and successful. For the same
reasons, we cannot predict when any products may begin to produce net cash
inflows.
Most
of
our buccal delivery research and development activities to date have involved
developing our platform technology for use with insulin and morphine.
Insubstantial amounts have been expended on projects with other drugs, and
those
projects involved a substantial amount of platform technology development.
As a
result, we have not made significant distinctions in the accounting for research
and development expenses among products, as a significant portion of all
research has involved improvements to the platform technology in connection
with
insulin, which may benefit all of our potential buccal products. During the
last
fiscal quarter ended October 31, 2006, approximately 68% of our $1,592,933
in
research expenses was attributable to insulin and platform technology
development, and we did not have any research expenses related to morphine
or
other buccal projects. During the fiscal quarter ended October 31, 2005,
approximately 64% of our $676,379 in research expenses was attributable to
insulin and platform technology development, and we did not spend any money
on
morphine or fentanyl buccal projects.
15
Approximately
32% or $509,408 of our research and development expenses for the fiscal quarter
ended October 31, 2006 was related to Antigen's immunomedicine products compared
to approximately 36% or $246,358 for the fiscal quarter ended October 31, 2005.
Because these products are in the pre-clinical or Phase 1 stages of development
(with the exception of the Antigen HER-2/neu positive breast cancer vaccine
for
which Phase 2 clinical trials have been initiated), all of the expenses were
accounted for as basic research and no distinctions were made as to particular
products. Because of the early stage of development, we cannot predict the
timing of completion of any products arising from this technology, or when
products from this technology might begin producing revenues.
Results
of Operations
Three
Months Ended October 31, 2006 Compared to Three Months Ended October 31,
2005
Our
net
loss for the quarter ended October 31, 2006 was $3,658,045 versus $9,003,218
in
the corresponding quarter of the prior fiscal year. The decrease in net loss
in
this fiscal quarter versus the corresponding quarter of the prior fiscal year
is
primarily due to the decrease in interest expense and loss on extinguishment
of
debt incurred in connection with convertible debentures entered into during
2006
fiscal year. Our operating loss for the quarter increased to $3,980,182 compared
to $2,107,485 in the first fiscal quarter of 2006. The increase resulted from
an
increase in general and administrative expenses (to $2,494,739 from $1,474,856),
and an increase in research and development expenses (to $1,592,933 from
$676,379). Our revenues increased from $43,750 in the first quarter of the
prior
fiscal year to $139,005 for the quarter ended October 31, 2006.
The
increase in general and administrative expenses for the quarter ended October
31, 2006 is due primarily to the increase of cash and non cash compensation
to
financial and other consultants in the quarter ended October 31, 2006 compared
to such compensation paid in the first quarter of the prior fiscal year,
increase in legal and accounting and travel expenses and an increase in
executive and other employee compensation.
The
increase in research and development expenses for the quarter ended October
31,
2006 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.
Our
interest expense in the first fiscal quarter of 2007 decreased to $257,590
compared to interest expense of $6,739,575 in the first fiscal quarter of 2006
due to smaller number of convertible debentures still outstanding and none
entered during first fiscal quarter of 2007. Our loss on extinguishment of
debt,
also incurred in connection with convertible debentures, was $58,518 in the
first fiscal quarter of 2007 compared to $162,348 in the same quarter for the
last year. Our interest income increased to $603,772 in the first fiscal quarter
of 2007 compared to $1,337 in the same quarter for the last year primarily
due
to substantially higher cash and short term investment balances during the
current fiscal quarter. We received a slightly higher income from rental
operations (net of expense) of $34,473 in the first fiscal quarter of 2007
compared to $4,853 in the same quarter for the last year.
Developments
In
August
2006, we introduced our new Glucose RapidSpray™ product which became available
in independent retail pharmacies in the United States and Canada in October,
2006.
In
August, 2006, we entered into an agreement with the Euroclinic in Athens, Greece
to commence clinical trials on an immunotherapeutic vaccine for prostate cancer
developed by Antigen. The compound has been in clinical trials for more than
a
year at the Walter Reed Army Medical Center in patients with breast cancer.
We
believe that the trials conducts at Walter Reed are promising and have
consequently deemed it appropriate to expand the studies to include patients
with prostrate cancer. We expect that these studies will begin in December
2006.
In
September, 2006, we executed a clinical supply agreement and a related quality
agreement with Cardinal Health PTS, LLC. We have contracted with Cardinal Health
for the manufacture of clinical trial batches of our oral insulin product,
Generex Oral-lyn™.
In
November, 2006, we entered into an agreement with the Lebanese-Canadian Hospital
in Beirut, Lebanon to conduct a human clinical trial of a synthetic avian
influenza vaccine developed by Antigen Express, representing the first studies
to be conducted in humans. This vaccine is based upon peptide-synthesis
technology which we believe can be manufactured rapidly, easily and at
inexpensive cost. The study is being undertaken with the approval of the
appropriate Lebanese governmental and regulatory bodies.
16
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
October 31, 2006, we had cash and short-term investments of approximately $49
million, a decrease of $3.6 from the balance as of the end of the prior fiscal
year. As of October 31, 2006, we believed that our anticipated cash position
was
sufficient to meet our working capital needs for the next nine 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. While we
have
generally been able to raise equity capital as required, our cash balances
were
very low during parts of 2005 and unforeseen problems with our clinical program
or materially negative developments in general economic conditions could
interfere with our ability to raise additional equity capital as needed, or
materially adversely affect the terms upon which such capital is available.
If
we are unable to raise additional capital as needed, we could be required to
“scale back” or otherwise revise our business plan. Any significant scale back
of operations or modification of our business plan due to a lack of funding
could be expected to affect our prospects materially and adversely.
At
October 31, 2006, we had 6% secured convertible debentures outstanding in the
aggregate principal amount of $538,462, which were issued in connection with
the
Securities Purchase Agreement dated November 10, 2004 and the amendments
thereto. The outstanding debentures have a term of fifteen months and amortize
over thirteen months in thirteen equal monthly installments beginning on the
first day of the third month following their issuance (May 1, 2006). Interest
on
the principal amount outstanding accrues at a rate of 6% per annum. We may
pay
principal and accrued interest in cash or, at our option, in shares of our
common stock. If the we elect to pay principal and interest in shares of our
common stock, the value of each share of common stock will be equal to the
lesser of (i) $1.25 and (ii) ninety percent (90%) of the average of the daily
volume weighted average price for the common stock over the twenty trading
day
period immediately preceding the date of payment. At the option of the holder
of
each debenture, the principal amount outstanding under each such debenture
is
initially convertible into shares of our common stock at a conversion price
of
$1.25.
Upon
the
occurrence of an “Event of Default” with respect to each debenture, the full
principal amount of each such debenture, together with interest and other
amounts owing in respect thereof, may be accelerated at the holder’s option and
payable in cash. The aggregate amount payable upon an Event of Default shall
be
equal to the “Mandatory Prepayment Amount.” The Mandatory Prepayment Amount for
a debenture shall equal the sum of (i) the greater of: (A) 130% of the principal
amount of the debentures to be prepaid, plus all accrued and unpaid interest
thereon, or (B) the principal amount of the debentures to be prepaid, plus
all
other accrued and unpaid interest thereof, divided by the conversion price
on
(x) the date the Mandatory Prepayment Amount is demanded or otherwise due or
(y)
the date the Mandatory Prepayment Amount is paid in full, whichever is less,
multiplied by the daily volume weighted average price of the common stock on
(x)
the date the Mandatory Prepayment Amount is demanded or otherwise due or (y)
the
date the Mandatory Prepayment Amount is paid in full, whichever is greater,
and
(ii) all other amounts, costs, expenses and liquidated damages due in respect
of
such debentures. The interest rate on the debentures will accrue at the rate
of
18% per annum, or such lower maximum amount of interest permitted to be charged
under applicable law, beginning five days after the occurrence of any Event
of
Default that results in the acceleration of the debentures. A late fee of 18%
per annum, or such lower maximum amount of interest permitted to be charged
under applicable law, will accrue on a daily basis on all overdue accrued and
unpaid interest under the debentures from the due date to the date of
payment.
Since
November 2004, we have issued an aggregate of 20,285,658 shares of common stock
resulting from the conversion and repayment of an aggregate of $17,122,435
of
debenture principal and accrued interest issued under the auspices of the
Securities Purchase Agreement dated November 10, 2004 and amendments thereto.
As
of
October 31, 2006, warrants issued under the auspices of the Securities Purchase
Agreement dated November 10, 2004 and amendments thereto were exercised to
purchase an aggregate of 34,385,904 shares of our common stock at varying
exercise prices for an aggregate proceeds to us of $35,092,210.
All
of
the shares issued upon the conversion and repayment of debentures and exercise
of warrants have been registered with the SEC for resale by the
investors.
17
At
October 31 2006, the following warrants issued under the auspices of the
Securities Purchase Agreement dated November 10, 2004 and amendments thereto
and
the Securities Purchase Agreement dated June 1, 2006 were
outstanding:
Date
Issued
|
Aggregate
No.
of Shares
Unexercised
|
|
Exercise
Price*
|
|
Exercise
Date
|
|
Expiration
Date
|
||||||
January
26, 2006
|
522,226
|
$
|
1.60
|
June
2, 2006
|
July
22, 2011
|
||||||||
February
27, 2006
|
4,770,617
|
$
|
3.00
|
August
27, 2006
|
August
27, 2011
|
||||||||
February.
28, 2006
|
272,120
|
$
|
1.25
|
August
31, 2006
|
August
31, 2011
|
||||||||
March
1, 2006
|
800,000
|
$
|
3.00
|
September
6, 2006
|
September
6, 2011
|
||||||||
June
1, 2006
|
2,560,980
|
$
|
2.45
|
June
1, 2006
|
June
1, 2011
|
||||||||
June
2, 2006
|
3,273,144
|
$
|
2.35
|
June
2, 2006
|
June
2, 2011
|
*subject
to anti-dilution adjustments upon issuance of securities at a price per share
of
common stock less than the then applicable exercise price or the market price
of
our common stock at that time, whichever is lower
Critical
Accounting Policies
Our
discussion and analysis of our financial condition and results of operations
is
based on our consolidated financial statements which have been prepared in
conformity with accounting principles generally accepted in the United States
of
America. It requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual results
could differ from those estimates.
We
consider certain accounting policies related to impairment of long-lived assets,
intangible assets and accrued liabilities to be critical to our business
operations and the understanding of our results of operations:
Revenue
Recognition.
Revenues are recognized when the following fundamental criteria are met: (i)
persuasive evidence of an arrangement exists; (ii) delivery has occurred; (iii)
the price to the customer is fixed or determinable; and (iv) collection of
the
sales price is reasonably assured. Delivery occurs when goods are shipped and
title and risk of loss transfer to the customer, in accordance with the terms
specified in the arrangement with the customer. Revenue recognition is deferred
in all instances where the earnings process is incomplete. Certain product
sales
are made to retailers under agreements allowing for a right to return unsold
products. Recognition of revenue on all sales to these retailers is deferred
until a provision for returns can be reasonably estimated based on
historical experience or the products are sold to a third party.
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.
18
Contractual
Obligations
Payments
Due by Period
Contractual
Obligations
|
Total
|
Less
than 1
Year
|
1-3
years
|
3-5
years
|
More
than
5
years
|
|||||||||||
Long-Term
Debt Obligations
|
3,584,826
|
972,847
|
1,386,327
|
1,225,652
|
0
|
|||||||||||
Capital
Lease Obligations
|
0
|
0
|
0
|
0
|
0
|
|||||||||||
Operating
Lease Obligations
|
76,730
|
25,146
|
48,229
|
3,355
|
0
|
|||||||||||
Purchase
Obligations
|
0
|
0
|
0
|
0
|
0
|
|||||||||||
Other
Long-Term Liabilities Reflected on the Registrant's
Balance Sheet under GAAP
|
0
|
0
|
0
|
0
|
0
|
|||||||||||
Total
|
$
|
3,661,556
|
$
|
997,993
|
$
|
1,434,556
|
$
|
1,229,007
|
$
|
0
|
Related
Party Transactions
On
May 3,
2001, we advanced $334,300 to each of three senior officers, who are also our
stockholders, in exchange for promissory notes. These notes bore interest at
8.5% per annum and were payable in full on May 1, 2002. These notes were
guaranteed by a related company owned by these officers and secured by a pledge
of 2,500,000 shares of our common stock owned by this related company. On June
3, 2002, our Board of Directors extended the maturity date of the loans to
October 1, 2002. The other terms and conditions of the loans and guaranty
remained unchanged and in full force and effect. As of July 31, 2002, the
balance outstanding on these notes, including accrued interest, was $1,114,084.
Pursuant to a decision made by the Compensation Committee as of August 30,
2002,
these loans were satisfied through the application of 592,716 shares of pledged
stock, at a value of $1.90 per share, which represented the lowest closing
price
during the sixty days prior to August 30, 2002.
Prior
to
January 1, 1999, a portion of our general and administrative expenses resulted
from transactions with affiliated persons, and a number of capital transactions
also involved affiliated persons. Although these transactions were not the
result of "arms-length" negotiations, we do not believe that this fact had
a
material impact on our results of operations or financial position. Prior to
December 31, 1998, we classified certain payments to executive officers for
compensation and expense reimbursements as "Research and Development - related
party" and "General and Administrative - related party" because the executive
officers received such payments through personal services corporations rather
than directly. After December 31, 1998, these payments have been and will
continue to be accounted 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
August
7, 2002, we purchased real estate with an aggregate purchase price of
approximately $1.6 million from an unaffiliated party. In connection with that
transaction, Angara Enterprises, Inc., a licensed real estate broker that is
an
affiliate of Anna Gluskin, our Chairman, President and Chief Executive Officer,
received a commission from the proceeds of the sale to the seller in the amount
of 3% of the purchase price, or $45,714. We believe that this is less than
the
aggregate commission which would have been payable if a commission had been
negotiated with an unaffiliated broker on an arm's length basis.
On
December 9, 2005, our Board of Directors also approved a one-time recompense
payment in the aggregate amount of $1,000,000 for each of Ms. Gluskin and Ms.
Rose Perri, our Chief Operating Officer, Chief Financial Officer, Treasurer
and
Secretary, in recognition of the company’s failure to remunerate each of Ms.
Gluskin and Ms. Perri in each of the fiscal years ended July 31, 1998, 1999,
2000 and 2001 in a fair and reasonable manner commensurate with comparable
industry standards and Ms. Gluskin’s and Ms. Perri’s duties, responsibilities
and performance during such years. The payment of such amount to each of Ms.
Gluskin and Ms. Perri will be made (a) in cash at such time or times and in
such
amounts as determined solely by Ms. Gluskin or Ms. Perri, as applicable, and/or
(b) in shares of our common stock at such time or times as determined by Ms.
Gluskin or Ms. Perri, as applicable, provided that the conversion price for
any
such shares shall be equal to the average closing price of our common stock
on
the NASDAQ Capital Market for the 20 successive trading days immediately
preceding, but not including, December 9, 2005. The amounts were not paid as
of
November 17, 2006 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.
19
On
December 9, 2005, our Board of Directors also approved the grant to Ms. Perri
of
a right of first refusal in respect of any sale, transfer, assignment or other
disposition of either or both real properties municipally known as 1740 Sismet
Road, Mississauga, Ontario and 98 Stafford Drive, Brampton, Ontario
(collectively, the “Properties”). We granted Ms. Perri this right in recognition
of the fair market value transfer to us during the fiscal year ended July 31,
1998 by Ms. Perri (or parties related to her) of the Properties.
We
utilize a management company to manage all of our real properties. The property
management company is owned by Ms. Perri, Ms. Gluskin and the estate of Mark
Perri, our former Chairman of the Board. In the fiscal quarters ended October
31, 2005 and 2006, we paid the management company approximately $8,600 and
$11,856, respectively, in management fees.
David
Wires, one of our directors, is a partner of the firm Wires Jolley LLP. Wires
Jolley represents us in various matters. During fiscal 2006, we paid
approximately $85,000 in fees to Wires Jolley. We continue to use Wires Jolley
and expect to pay legal fees in similar amounts to the firm in fiscal 2007.
New
Accounting Pronouncements
In
February 2006, the FASB issued SFAS No. 155, “Accounting for Certain Hybrid
Financial Instruments - an amendment of FASB Statements No. 133 and 140,” to
simplify and make more consistent the accounting for certain financial
instruments. Specifically, SFAS No. 155 amends SFAS No. 133, “Accounting for
Derivative Instruments and Hedging Activities,” to permit fair value
remeasurement for any hybrid financial instrument with an embedded derivative
that otherwise would require bifurcation, provided that the whole instrument
is
accounted for on a fair value basis. SFAS No. 155 amends SFAS No. 140,
“Accounting for the Impairment or Disposal of Long-Lived Assets, “to allow a
qualifying special-purpose entity (SPE) to hold a derivative financial
instrument that pertains to a beneficial interest other than another derivative
financial instrument. SFAS No. 155 applies to all financial instruments acquired
or issued after the beginning of an entity’s first fiscal year that begins after
September 15, 2006, with earlier application allowed. We are currently
evaluating the impact of adopting this statement.
In
March
2006, the FASB issued SFAS No. 156, “Accounting for Servicing of Financial
Assets,” to simplify accounting for separately recognized servicing assets and
servicing liabilities. SFAS No. 156 amends SFAS No. 140, “Accounting for
Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.”
Additionally, SFAS No. 156 permits, but does not require, an entity to choose
either the amortization method or the fair value measurement method for
measuring each class of separately recognized servicing assets and servicing
liabilities. SFAS No. 156 applies to all separately recognized servicing assets
and servicing liabilities acquired or issued after the beginning of an entity’s
fiscal year that begins after September 15, 2006, although early adoption is
permitted. We are currently evaluating the impact of adopting this
statement.
In
July
2006, the FASB published FASB Interpretation No. 48 (FIN No. 48), “Accounting
for Uncertainty in Income Taxes”, to address the noncomparability in reporting
tax assets and liabilities resulting from a lack of specific guidance in SFAS
No. 109, “Accounting for Income Taxes,” on the uncertainty in income taxes
recognized in an enterprise’s financial statements. FIN No. 48 will apply to
fiscal years beginning after December 15, 2006, with earlier adoption permitted.
We do not expect that the adoption of FIN No. 48 will have a significant impact
on our consolidated results of operations or financial position.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,” to
eliminate the diversity in practice that exists due to the different definitions
of fair value and the limited guidance for applying those definitions in GAAP
that are dispersed among the many accounting pronouncements that require fair
value measurements. SFAS No. 157 retains the exchange price notion in earlier
definitions of fair value, but clarifies that the exchange price is the price
in
an orderly transaction between market participants to sell an asset or liability
in the principal or most advantageous market for the asset or liability.
Moreover, the SFAS states that the transaction is hypothetical at the
measurement date, considered from the perspective of the market participant
who
holds the asset or liability. Consequently, fair value is defined as the price
that would be received to sell an asset or paid to transfer a liability in
an
orderly transaction between market participants at the measurement date (an
exit
price), as opposed to the price that would be paid to acquire the asset or
received to assume the liability at the measurement date (an entry
price).
SFAS
No.
157 also stipulates that, as a market-based measurement, fair value measurement
should be determined based on the assumptions that market participants would
use
in pricing the asset or liability, and establishes a fair value hierarchy that
distinguishes between (a) market participant assumptions developed based on
market data obtained from sources independent of the reporting entity
(observable inputs) and (b) the reporting entity's own assumptions about market
participant assumptions developed based on the best information available in
the
circumstances (unobservable inputs). Finally, SFAS No. 157 expands disclosures
about the use of fair value to measure assets and liabilities in interim and
annual periods subsequent to initial recognition. Entities are encouraged to
combine the fair value information disclosed under SFAS No. 157 with the fair
value information disclosed under other accounting pronouncements, including
SFAS No. 107, “Disclosures about Fair Value of Financial Instruments,” where
practicable. The guidance in this Statement applies for derivatives and other
financial instruments measured at fair value under SFAS No. 133 , “Accounting
for Derivative Instruments and Hedging Activities,” at initial recognition and
in all subsequent periods. SFAS No. 157 is effective for financial statements
issued for fiscal years beginning after November 15, 2007, and interim periods
within those fiscal years, although earlier application is encouraged.
Additionally, prospective application of the provisions of SFAS No. 157 is
required as of the beginning of the fiscal year in which it is initially
applied, except when certain circumstances require retrospective application.
We
are currently evaluating the impact of adopting this statement.
20
In
September 2006, the FASB issued “Statement of Financial Accounting Standards No.
158, Employers’ Accounting for Defined Benefit Pension and Other Postretirement
Plans (an amendment of FASB Statements No. 87, 88, 106, and 132R)”, which will
require employers to fully recognize the obligations associated with
single-employer defined benefit pension, retiree healthcare and other
postretirement plans in their financial statements. Under past accounting
standards, the funded status of an employer’s postretirement benefit plan (i.e.,
the difference between the plan assets and obligations) was not always
completely reported in the balance sheet. Past standards only required an
employer to disclose the complete funded status of its plans in the notes to
the
financial statements. SFAS No. 158 applies to plan sponsors that are public
and
private companies and nongovernmental not-for-profit organizations. The
requirement to recognize the funded status of a benefit plan and the disclosure
requirements are effective as of the end of the fiscal year ending after
December 15, 2006, for entities with publicly traded equity securities, and
at
the end of the fiscal year ending after June 15, 2007, for all other entities.
The requirement to measure plan assets and benefit obligations as of the date
of
the employer’s fiscal year-end statement of financial position is effective for
fiscal years ending after December 15, 2008. We are currently evaluating the
impact of adopting this statement.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
We
are
exposed to market risks associated with changes in the exchange rates between
U.S. and Canadian currencies and with changes in the interest rates related
to
our fixed rate debt. We do not believe that any of these risks will have a
material impact on our financial condition, results of operations and cash
flows.
At
the
present time, we maintain our cash in short-term government or government
guaranteed instruments, short-term commercial paper, interest bearing bank
deposits or demand bank deposits which do not earn interest. A substantial
majority of these instruments and deposits are denominated in U.S. dollars,
with
the exception of funds denominated in Canadian dollars on deposit in Canadian
banks to meet short-term operating needs in Canada. At the present time, with
the exception of professional fees and costs associated with the conduct of
clinical trials in the United States and Europe, substantially all of our
operating expense obligations are denominated in Canadian dollars. We do not
presently employ any hedging or similar strategy intended to mitigate against
losses that could be incurred as a result of fluctuations in the exchange rates
between U.S. and Canadian currencies.
As
of
October 31, 2006, we have fixed rate debt totaling $3,046,364. This amount
consists of the following:
Loan
Amount
|
Interest
Rate
per
Annum
|
|||
427,861
|
6.82
|
%
|
||
265,284
|
6.82
|
%
|
||
647,970
|
7.60
|
%
|
||
356,920
|
8.50
|
%
|
||
206,223
|
10
|
%
|
||
1,142,106
|
6.07
|
%
|
||
3,046,364
|
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.
21
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, is recorded, processed,
summarized and reported within the time periods specified in the rules and
forms
of the Securities and Exchange Commission (the “SEC”) and is accumulated and
communicated to the Company’s management, as appropriate, to allow timely
decisions regarding required disclosures.
Changes
in internal control over financial reporting
There
was
no change in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15(d)-15(f) under the Exchange Act) during the period covered
by
this Quarterly Report on Form 10-Q that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
Shemano
Group, Inc.
On
September 26, 2006, Shemano Group, Inc. initiated a National Association of
Securities Dealers arbitration proceeding against us. Shemano claims it is
entitled to be paid fees in connection with our private placements in September
2005, January 2006 and June 2006, pursuant to an Exclusive Finder’s Agreement
dated November 1, 2004. Shemano claims it is entitled to fees of $945,000 in
cash and warrants exercisable for 405,000 shares of our common stock. We have
since filed an answer with the NASD and plan to defend this action vigorously.
We are not able to predict the ultimate outcome of this legal proceeding at
the
present time.
We
are
involved in certain other legal proceedings in addition to those specifically
described herein. Subject to the uncertainty inherent in all litigation, we
do
not believe at the present time that the resolution of any of these legal
proceedings is likely to have a material adverse effect on our financial
position, operations or cash flows.
With
respect to all litigation matters, as additional information concerning the
estimates used by us becomes known, we reassess each matter’s position both with
respect to accrued liabilities and other potential exposures.
Item
1A. Risk Factors.
In
addition to the other information included in this Quarterly Report on Form
10-Q, you should carefully review and consider the factors discussed in
Part
I, Item 1A - Risk Factors
of our
Annual Report on Form 10-K for the year ended July 31, 2006, certain of which
have been updated below. These factors materially affect our business, financial
condition or future results of operations. The risks, uncertainties and other
factors described in our Annual Report on Form 10-K and below are not the only
ones facing our company. Additional risks, uncertainties and other factors
not
presently known to us or that we currently deem immaterial may also impair
our
business operations, financial condition or operating results. Any of the risks,
uncertainties and other factors could cause the trading price of our common
stock to decline substantially.
22
Risks
Related to Our Financial Condition
We
have a history of losses and will incur additional
losses.
We
are a
development stage company with a limited history of operations, and do not
expect sufficient revenues to support our operation in the immediately
foreseeable future. In the quarterly period ending October 31, 2006, we have
received nominal revenues from sales of our confectionary, Glucose RapidSpray™,
and we expect to receive some revenue from the sale of our oral insulin product
in Ecuador in the second quarter of fiscal 2007. To date, we have not been
profitable and our accumulated net loss was $189,858,300 at October 31, 2006.
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 selling in Ecuador and Glucose
RapidSpray™ which we began selling in the United States in October 2006, our
product candidates are in research or early stages of pre-clinical and clinical
development. We will need to conduct substantial additional research,
development and clinical trials. We will also need to receive necessary
regulatory clearances both in the United States and foreign countries and obtain
meaningful patent protection for and establish freedom to commercialize each
of
our product candidates. We cannot be sure that we will obtain required
regulatory approvals, or successfully research, develop, commercialize,
manufacture and market any other product candidates. We expect that these
activities, together with future general and administrative activities, will
result in significant expenses for the foreseeable future.
Risks
Related to Marketing of Our Potential Products
We
may not be able to compete with treatments now being marketed and developed,
or
which may be developed and marketed in the future by other
companies.
Our
products will compete with existing and new therapies and treatments. We are
aware of a number of companies currently seeking to develop alternative means
of
delivering insulin, as well as new drugs intended to replace insulin therapy
at
least in part. We are also aware of a number of companies currently seeking
to
develop alternative means of enhancing and suppressing peptides. In the longer
term, we also face competition from companies that seek to develop cures for
diabetes and other malignant, infectious, autoimmune and allergic diseases
through techniques for correcting the genetic deficiencies that underlie such
diseases.
Numerous
pharmaceutical, biotechnology and drug delivery companies, hospitals, research
organizations, individual scientists and nonprofit organizations are engaged
in
the development of alternatives to our technologies. Some of these companies
have greater research and development capabilities, experience, manufacturing,
marketing, financial and managerial resources than we do. Accordingly, our
competitors may succeed in developing competing technologies, obtaining FDA
approval for products or gaining market acceptance more rapidly than we can.
In
January, 2006, the FDA approved Pfizer, Inc.’s inhalable form of insulin, the
first non-injected insulin to be approved by the FDA. Pfizer’s product in
inhaled through the mouth and absorbed in the lungs. Initial supplies of this
product, which is marketed as Exubera®, became available in the U.S. in
September 2006. We understand that an expanded roll-out of Exubera® to
primary-care physicians in the U.S., which Pfizer previously targeted for
November 2006, will begin in January 2007. While we believe that absorption
though the buccal cavity offers several advantages over absorption through
the
lungs, Pfizer’s early approval could allow it to capture a large portion of the
market.
Item.
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
Unregistered
Sales of Equity Securities
As
previously reported in our Quarterly Report on Form 10-Q for the three-month
period ended April 30, 2006, our Board of Directors on April 17, 2006 approved
the issuance of an aggregate of 72,000 shares of our restricted common stock
as
partial consideration the provision of services by The Abajian Group, LLC
(“Abajian”) under an agreement with us relating to the solicitation, evaluation
and design of third-party wholesale and retail distribution channels for certain
of our products. Subsequently, our Board of Directors approved the issuance
of
an additional 28,000 shares pursuant to this agreement and approved the
modification of certain provisions of this agreement. These shares (100,000
in
the aggregate) were qualified for public re-sale pursuant to the registration
statement, which we filed and which was declared effective by the SEC on July
21, 2006. During the three months ended October 31, 2006, we issued 25,000
of
such shares to Ananindeau, S.A., an entity controlled by the principal of
Abajian, pursuant to this agreement. As indicated in our Quarterly Report on
Form 10-Q for the quarterly period ended April 30, 2006, we believe that the
issuance of such shares is exempt from registration under the Securities Act
in
reliance upon Section 4(2) thereof. The issuance of such securities does
not involve the use of underwriters, and no commissions will be paid in
connection therewith.
23
As
previously reported in our Annual Report on Form 10-K for the fiscal year ended
July 31, 2006, our Board of Directors, on September 8, 2006, approved the
issuance of up to 300,000 shares our restricted common stock (in equal monthly
installments of 25,000 shares) in payment of services to be rendered by CEOcast,
Inc., a consultant, pursuant to an agreement to provide us with investor
relation services for the period August 22, 2006 to August 21, 2007. During
the
three months ended October 31, 2006, the Company issued 75,000 shares of common
stock to CEOcast, Inc. pursuant to this agreement. The sale of such shares
was
exempt from registration under the Securities Act in reliance upon Section
4(2)
thereof. We believe that CEOcast, Inc. is an “accredited investor” as that term
is defined in Rule 501(a) of Regulation D under the Securities Act. The
certificates issued for the shares of common stock will be legended to indicate
that they are restricted. The sales of such securities did not involve the
use
of underwriters, and no commissions were paid in connection therewith.
On
October 6, 2006, our Board of Directors approved the issuance of an aggregate
of
100,000 shares of common stock (valued at $183,000 based on the closing trading
price of our common stock on the date of the issuance) to
three
of employees in respect of research and development work on our metformin gum
product and the preparation and filing of patent applications in respect
thereof. Each employee received an aggregate of 33,333 shares of our common
stock. The sales of such shares were exempt from registration under the
Securities Act in reliance upon Section 4(2) thereof. Each of the three
employees is a resident of Canada. The issuances of such shares did not involve
the use of underwriters, and no commissions were paid in connection with the
issuances or sales, if any, thereof.
In
October 2006, we issued 2,262 shares of our common stock (qualified for public
re-sale by a registration statement declared effective by the SEC on July 21,
2006) to a consultant as partial consideration pursuant to a consulting
agreement between the consultant and us. The issuance of such shares was exempt
from registration under the Securities Act, in reliance upon Section 4(2)
thereof. The consultant is a resident of Canada. The issuance of such shares
did
not involve the use of underwriters, and no commissions were paid in connection
with the issuance or sale, if any, thereof.
The
following unregistered sales of our equity securities occurred during our
previous quarterly period which ended July 31, 2006:
Pursuant
to the Generex Biotechnology 2006 Stock Plan, we issued 5,000 shares of
restricted common stock as incentive compensation to an employee of our
subsidiary, Generex Pharmaceuticals Inc., in May 2006. The issuance of such
shares was exempt from registration under the Securities Act, in reliance upon
Section 4(2) thereof. The employee recipient is a resident of Canada. The
issuance of such shares did not involve the use of underwriters, and no
commissions were paid in connection with the issuance or sale, if any, thereof.
Pursuant
to an agreement for investor relation and financial communication services,
our
Board of Directors on May 30, 2006 approved the issuance of shares of our
restricted common stock to an individual consultant. In consideration of the
services to be provided pursuant to this agreement, the consultant will be
entitled to payment in the form of shares of our restricted common stock
(without any registration rights) for up to a maximum of 12 months in the
following monthly amount: USD $7,000 divided by the average closing price of
our
common stock on the NASDAQ Capital Market for the five-trading days immediately
preceding the commencement of the relevant 30-day period. The sale of such
shares is exempt from registration under the Securities Act in reliance upon
Section 4(2) thereof. We believe that the advisor is an “accredited investor” as
that term is defined in Rule 501(a) of Regulation D under the Securities Act.
The certificates issued for the shares of common stock will be legended to
indicate that they are restricted. The sales of such securities did not involve
the use of underwriters, and no commissions were paid in connection therewith.
In
May
2006, following approval by our Board of Directors, we issued to Sound Capital,
Inc. a warrant to purchase up to 25,000 shares of our restricted common stock
in
consideration of investor relation/communication activities performed by Sound
Capital for the company. The exercise price per share under the warrant is
$1.91, which represents the average closing price of our common stock on the
NASDAQ Capital Market for the ten trading days ended May 26, 2006. The sale
of
such shares was exempt from registration under the Securities Act in reliance
upon Section 4(2) thereof. We believe that Sound Capital is an “accredited
investor” as that term is defined in Rule 501(a) of Regulation D under the
Securities Act. The sale of such securities did not involve the use of
underwriters, and no commissions were paid in connection therewith. The shares
underlying the warrant were registered for re-sale pursuant to the registration
statement that was declared effective by the SEC on July 21, 2006.
24
Issuer
Purchases of Equity Securities
Neither
we nor any affiliated purchaser (as defined in Section 240.10 b-18(a)(3) of
the
Exchange Act) purchased any of our equity securities during the fiscal quarter
ended October 31, 2006.
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.
25
Item
6. Exhibits.
Exhibit
Number
|
Description of Exhibit(1) | |||
2
|
Agreement
and Plan of Merger among Generex Biotechnology Corporation, Antigen
Express, Inc. and AGEXP Acquisition Inc. (incorporated by reference
to
Exhibit 2.1 to Generex Biotechnology Corporation’s Current Report on Form
8-K filed on August 15, 2003)
|
|||
|
|
|||
3(I)
|
Restated
Certificate of Incorporation of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 3(II) to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on June 19,
2006)
|
|||
|
|
|||
3(II)
|
Bylaws
of Generex Biotechnology Corporation (incorporated by reference to
Exhibit
3.2 to Generex Biotechnology Corporation’s Registration Statement on Form
S-1 (File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|||
4.1
|
Form
of common stock certificate (incorporated by reference to Exhibit
4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|||
4.2
|
Warrant
issued to Elliott International, L.P. and Elliott Associates, L.P.,
dated
July 5, 2001 (incorporated by reference to Exhibit 9 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on July 17,
2001)
|
|||
|
|
|||
4.3.1
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|||
4.3.2
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|||
4.3.3
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|||
4.4.1
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.4 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|||
4.4.2
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.5 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|||
4.4.3
|
Form
of Warrant granted to Cranshire Capital, L.P. dated June 6, 2003
(incorporated by reference to Exhibit 4.6 to Generex Biotechnology
Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003
filed on August 13, 2003)
|
|||
|
|
|||
4.4.4
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to
Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|||
|
|
|||
4.5.1
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
26
Exhibit
Number
|
Description of Exhibit(1) |
4.5.2
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|||
4.5.3
|
Form
of Warrant issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|||
4.5.4
|
Form
of Additional Investment Right issued in connection with Exhibit
4.5.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|||
4.6.1
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.6.2
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.6.3
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|||
4.6.4
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.7.1
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.7.2
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.7.3
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|||
4.7.4
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.8.1
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|||
4.8.2
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|||
4.8.3
|
Warrant
issued in connection with Exhibit 4.8.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|||
4.8.4
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.8.5
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|||
4.9.1
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
27
Exhibit
Number
|
Description of Exhibit(1) |
4.9.2
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|||
4.9.3
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.10.1
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.10.2
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.10.3
|
Warrant
issued in connection with Exhibit 4.10.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|||
4.10.4
|
Additional
Investment Right issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|||
4.11.1
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|||
4.11.2
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|||
|
|
|||
4.11.3
|
Form
of Warrant issued in connection with Exhibit 4.11.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|||
4.11.4
|
Form
of Additional Investment Right issued in connection Exhibit 4.11.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|||
|
|
|||
4.12.1
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|||
4.12.2
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.12.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|||
4.12.3
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|||
4.12.4
|
Form
of Additional Investment Right issued in connection with Exhibit
4.12.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|||
4.12.5
|
Custodial
and Security Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation, Feldman Weinstein LLP, as custodian, and
the
investors named therein (incorporated by reference to Exhibit 4.6
to
Generex Biotechnology Corporation’s Report on Form 8-K filed on November
12, 2004)
|
28
Exhibit
Number
|
Description of Exhibit(1) |
4.12.6
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|||
4.13
|
Termination
Agreement, dated December 17, 2004, by and among Generex Biotechnology
Corporation and Elan Corporation plc and Elan International Services,
Ltd.
(incorporated by reference to Exhibit 4.19 to Generex Biotechnology
Corporation’s Quarterly Report on Form 10-Q filed on June 14,
2005)
|
|||
|
|
|||
4.14
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|||
|
|
|||
4.15.1
|
Amendment
No. 1 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on June 17, 2005)
|
|||
|
|
|||
4.15.2
|
Form
of AIR Debenture issued in connection with Exhibit 4.15.1 (incorporated
by
reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|||
4.15.3
|
Form
of AIR Warrant issued in connection with Exhibit 4.15.1(incorporated
by
reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|||
4.15.4
|
Form
of Additional AIR issued in connection with Exhibit 4.15.1 (incorporated
by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s
Report on Form 10-K filed on October 31, 2005)
|
|||
|
|
|||
4.16.1
|
Amendment
No. 2 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|||
4.16.2
|
Form
of Air Debenture issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|||
4.16.3
|
Form
of AIR Warrant issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|||
4.16.4
|
Form
of Additional AIR issued in connection with Exhibit 4.16.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on September 9, 2005)
|
|||
|
|
|||
4.17
|
Form
of Warrant issued by Generex Biotechnology Corporation on October
27, 2005
(incorporated by reference to Exhibit 4.31 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 31,
2005)
|
|||
|
|
|||
4.18.1
|
Amendment
to the Additional Investment Right issued by Generex Biotechnology
Corporation to Omicron Master Trust on June 17, 2005 (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on October 31, 2005)
|
|||
|
|
|||
4.18.2
|
Additional
AIR Debenture issued by Generex Biotechnology Corporation to Omicron
Master Trust on October 27, 2005 issued in connection with Exhibit
4.18.1
(incorporated by reference to Exhibit 4.37 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|||
4.18.3
|
Additional
AIR Warrant issued by Generex Biotechnology Corporation to Omicron
Master
Trust on October 27, 2005 issued in connection with Exhibit 4.18.1
(incorporated by reference to Exhibit 4.38 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|||
4.19.1
|
Amendment
No. 3 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and among Generex Biotechnology Corporation and the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
29
Exhibit
Number
|
Description of Exhibit(1) |
4.19.2
|
Form
of AIR Debentures issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|||
4.19.3
|
Form
of AIR Warrants issued in connection with Exhibit 4.19.1 (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
|||
|
|
|||
4.19.4
|
Form
of Additional AIRs issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|||
4.20
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on June 17, 2005 in connection with the
First
AIR Exercise (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|||
4.21
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on September 8, 2005 in connection with
the
Second AIR Exercise (incorporated by reference to Exhibit 4.3 to
Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|||
4.22
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|||
|
|
|||
4.23
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
|
|
|||
4.24
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.25
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.26
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|||
4.27
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006).
|
|||
4.28
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|||
4.29
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|||
4.30
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|||
4.31
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
30
Exhibit
Number
|
Description of Exhibit(1) |
4.32
|
Form
of Additional Air Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
|
|||
4.33
|
Form
of Additional Air Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
|
|||
4.34
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
|||
4.35
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
|
|||
4.36
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
|||
4.37
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
|||
4.38
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
|
|||
4.39
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
|
|||
4.40
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
|||
4.41
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.37 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
|||
9
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|||
10.1
|
Quotation
Amendment for Contract Manufacturing of Oral-lyn™ entered into between
Generex Biotechnology Corporation and Cardinal Health PTS, LLC on
August
18, 2006 (subject to confidential treatment) (incorporated by reference
to
Exhibit 10.26 to Generex Biotechnology Corporation’s Report on Form 10-K
filed on October 16, 2006)
|
|||
10.2
|
Clinical
Supply Agreement entered into between Generex Biotechnology Corporation
and Cardinal Health PTS, LLC on September 6, 2006 (subject to confidential
treatment) (incorporated by reference to Exhibit 10.27 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|||
10.3
|
Summary
of Bonuses Awarded to Executive Officers in Respect of FY 2006
(incorporated by reference to Exhibit 10 to Generex Biotechnology
Corporation’s Report on Form 10-K/A filed on November 28,
2006)
|
|||
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
31
Exhibit
Number
|
Description of Exhibit(1) |
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.
32
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
GENEREX
BIOTECHNOLOGY CORPORATION
(Registrant)
|
||
|
|
|
Date:
December 8, 2006
|
By: | /s/ Anna E. Gluskin |
Anna
E. Gluskin
President
and Chief Executive Officer
|
Date:
December 8, 2006
|
By: | /s/ Rose C. Perri |
Rose
C. Perri
Chief
Financial Officer
|
33
Generex
Biotechnology Corporation
Form
10-Q
October
31, 2006
Exhibit
Index
Exhibit Number | Description of Exhibit(1) | ||||
2
|
|
Agreement
and Plan of Merger among Generex Biotechnology Corporation, Antigen
Express, Inc. and AGEXP Acquisition Inc. (incorporated by reference
to
Exhibit 2.1 to Generex Biotechnology Corporation’s Current Report on Form
8-K filed on August 15, 2003)
|
|||
|
|
|
|||
3(I)
|
|
Restated
Certificate of Incorporation of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 3(II) to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on June 19,
2006)
|
|||
|
|
|
|||
3(II)
|
|
Bylaws
of Generex Biotechnology Corporation (incorporated by reference to
Exhibit
3.2 to Generex Biotechnology Corporation’s Registration Statement on Form
S-1 (File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|
|||
4.1
|
|
Form
of common stock certificate (incorporated by reference to Exhibit
4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|
|||
4.2
|
|
Warrant
issued to Elliott International, L.P. and Elliott Associates, L.P.,
dated
July 5, 2001 (incorporated by reference to Exhibit 9 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on July 17,
2001)
|
|||
|
|
|
|||
4.3.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|
|||
4.3.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|
|||
4.3.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.4 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.5 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P. dated June 6, 2003
(incorporated by reference to Exhibit 4.6 to Generex Biotechnology
Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003
filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.4
|
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to
Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|||
|
|
|
|||
4.5.1
|
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
34
Exhibit Number | Description of Exhibit(1) |
4.5.2
|
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.3
|
|
Form
of Warrant issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.5.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|||
4.6.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|
|||
4.8.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|
|||
4.8.3
|
|
Warrant
issued in connection with Exhibit 4.8.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
35
Exhibit Number | Description of Exhibit(1) |
4.9.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.9.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.9.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.3
|
|
Warrant
issued in connection with Exhibit 4.10.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.11.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|
|||
4.11.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|||
|
|
|
|||
4.11.3
|
|
Form
of Warrant issued in connection with Exhibit 4.11.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|
|||
4.11.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.11.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|||
|
|
|
|||
4.12.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|
|||
4.12.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.12.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.12.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|
|||
4.12.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.12.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.12.5
|
|
Custodial
and Security Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation, Feldman Weinstein LLP, as custodian, and
the
investors named therein (incorporated by reference to Exhibit 4.6
to
Generex Biotechnology Corporation’s Report on Form 8-K filed on November
12, 2004)
|
36
Exhibit Number | Description of Exhibit(1) |
4.12.6
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.13
|
|
Termination
Agreement, dated December 17, 2004, by and among Generex Biotechnology
Corporation and Elan Corporation plc and Elan International Services,
Ltd.
(incorporated by reference to Exhibit 4.19 to Generex Biotechnology
Corporation’s Quarterly Report on Form 10-Q filed on June 14,
2005)
|
|||
|
|
|
|||
4.14
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|||
|
|
|
|||
4.15.1
|
|
Amendment
No. 1 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on June 17, 2005)
|
|||
|
|
|
|||
4.15.2
|
|
Form
of AIR Debenture issued in connection with Exhibit 4.15.1 (incorporated
by
reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.15.3
|
|
Form
of AIR Warrant issued in connection with Exhibit 4.15.1(incorporated
by
reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.15.4
|
|
Form
of Additional AIR issued in connection with Exhibit 4.15.1 (incorporated
by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s
Report on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.16.1
|
|
Amendment
No. 2 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.16.2
|
|
Form
of Air Debenture issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.16.3
|
|
Form
of AIR Warrant issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.16.4
|
|
Form
of Additional AIR issued in connection with Exhibit 4.16.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.17
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on October
27, 2005
(incorporated by reference to Exhibit 4.31 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 31,
2005)
|
|||
|
|
|
|||
4.18.1
|
|
Amendment
to the Additional Investment Right issued by Generex Biotechnology
Corporation to Omicron Master Trust on June 17, 2005 (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.18.2
|
|
Additional
AIR Debenture issued by Generex Biotechnology Corporation to Omicron
Master Trust on October 27, 2005 issued in connection with Exhibit
4.18.1
(incorporated by reference to Exhibit 4.37 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|
|||
4.18.3
|
|
Additional
AIR Warrant issued by Generex Biotechnology Corporation to Omicron
Master
Trust on October 27, 2005 issued in connection with Exhibit 4.18.1
(incorporated by reference to Exhibit 4.38 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|
|||
4.19.1
|
|
Amendment
No. 3 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and among Generex Biotechnology Corporation and the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
37
Exhibit Number | Description of Exhibit(1) |
4.19.2
|
|
Form
of AIR Debentures issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.3
|
|
Form
of AIR Warrants issued in connection with Exhibit 4.19.1 (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.4
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.20
|
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on June 17, 2005 in connection with the
First
AIR Exercise (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|
|||
4.21
|
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on September 8, 2005 in connection with
the
Second AIR Exercise (incorporated by reference to Exhibit 4.3 to
Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|
|||
4.22
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|||
|
|
|
|||
4.23
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
|
|
|
|||
4.24
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.25
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.26
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|||
4.27
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006).
|
||||
4.28
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
||||
4.29
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
||||
4.30
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
||||
4.31
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
38
Exhibit Number | Description of Exhibit(1) |
4.32
|
Form
of Additional Air Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
|
||||
4.33
|
Form
of Additional Air Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to
Generex Biotechnology Corporation’s Report on Form 10-K filed on October
16, 2006).
|
||||
4.34
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
||||
4.35
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
|
|||
4.36
|
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
|||
4.37
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
|||
4.38
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
|
||||
4.39
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
|
||||
4.40
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
||||
4.41
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.37 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
||||
9
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
10.1
|
Quotation
Amendment for Contract Manufacturing of Oral-lyn™ entered into between
Generex Biotechnology Corporation and Cardinal Health PTS, LLC on
August
18, 2006 (subject to confidential treatment) (incorporated by reference
to
Exhibit 10.26 to Generex Biotechnology Corporation’s Report on Form 10-K
filed on October 16, 2006)
|
||||
10.2
|
Clinical
Supply Agreement entered into between Generex Biotechnology Corporation
and Cardinal Health PTS, LLC on September 6, 2006 (subject to confidential
treatment) (incorporated by reference to Exhibit 10.27 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
||||
10.3 | Summary of Bonuses Awarded to Executive Officers in Respect of FY 2006 (incorporated by reference to Exhibit 10 to Generex Biotechnology Corporation’s Report on Form 10-K/A filed on November 28, 2006) | ||||
31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
39
Exhibit Number | Description of Exhibit(1) |
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.
40