GENEREX BIOTECHNOLOGY CORP - Annual Report: 2007 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
x
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d)
OF
THE
SECURITIES EXCHANGE ACT OF 1934
For
the
fiscal year ended July 31, 2007
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF
THE
SECURITIES EXCHANGE ACT OF 1934
For
the
transition period from _______ to _______
Commission
file number 000-25169
GENEREX
BIOTECHNOLOGY CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware
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98-0178636
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(State
or other jurisdiction of
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(I.R.S.
Employer
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incorporation
or organization)
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Identification
No.)
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33
Harbour Square, Suite 202, Toronto, Canada
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M5J
2G2
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(Address
of principal executive offices)
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(Zip
Code)
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(416)
364-2551
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last
report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
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Name
of each exchange on which registered
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Common
Stock, $.001 par value per share
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The
NASDAQ Stock Market LLC
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Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act. Yes
o No
þ
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act.
Yes
o No
þ
Indicate
by check mark
whether the registrant (1) has filed all reports required to be filed
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.
Yes
þ
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No
o
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Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to
this
Form 10-K. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer o
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Accelerated
filer þ
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Non-accelerated
filer o
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Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes
o
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No
þ
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As
of
January 31, 2007, the aggregate market value of the registrant’s common stock
held by non-affiliates of the registrant was $166,240,654 based on the closing
sale price as reported on the NASDAQ Capital Market. Generex Biotechnology
Corporation has no non-voting common equity. At October 03, 2007, there were
109,985,836 shares of common stock outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE: Portions of the Proxy Statement for the registrant’s
Annual Meeting of Stockholders, or an amendment to this Annual Report on Form
10-K, to filed within 120 after the end of the fiscal year ended July 31, 2007,
are incorporated by reference into Part III of this Annual Report on Form 10-K.
Generex
Biotechnology Corporation
Form
10-K
July
31, 2007
Index
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Page
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Forward-Looking
Statements
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1
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Part
I
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Item
1.
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Business.
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2
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Item
1A.
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Risk
Factors.
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21
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Item
1B.
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Unresolved
Staff Comments.
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28
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Item
2.
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Properties.
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28
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Item
3.
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Legal
Proceedings.
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29
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Item
4.
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Submission
of Matters to a Vote of Security Holders.
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30
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Part
II
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Item
5.
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Market
For Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities.
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31
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Item
6.
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Selected
Financial Data.
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33
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Item
7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
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34
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Item
7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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43
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Item
8.
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Financial
Statements and Supplementary Data.
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44
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Item
9.
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Changes
in and Disagreements With Accountants on Accounting and Financial
Disclosure.
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45
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Item
9A.
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Controls
and Procedures.
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45
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Item
9B.
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Other
Information.
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46
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Part
III
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Item
10.
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Directors,
Executive Officers and Corporate Governance.
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46
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Item
11.
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Executive
Compensation.
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46
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Item
12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters.
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46
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Item
13.
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Certain
Relationships and Related Transactions, and Director
Independence.
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46
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Item
14.
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Principal
Accountant Fees and Services.
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46
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Part
IV
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Item
15.
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Exhibits
and Financial Statement Schedules.
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47
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Signatures
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55
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Schedule
II
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56
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As
used
herein, the terms the “Company,” “Generex,” “we,” “us,” or “our” refer to
Generex Biotechnology Corporation, a Delaware corporation.
Forward-Looking
Statements
Certain
matters in this Annual Report on Form 10-K, including, without limitation,
certain matters discussed under Item
1 - Business,
Item
1A - Risk Factors,
Item
7 - Management’s Discussion and Analysis of Financial Condition and Results of
Operations
and
Item
7A - Quantitative and Qualitative Disclosures about Market Risk,
constitute “forward-looking statements” within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. All statements, other than statements of historical
facts, included in this Annual 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," “anticipates,” "plans," "intends," "believes," "will,"
"estimates," "projects" 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:
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our
expectations concerning product candidates for our
technologies;
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our
expectations concerning existing or potential development and license
agreements for third-party collaborations and joint
ventures;
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our
expectations of when different phases of clinical activity may
commence;
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our
expectations of when regulatory submissions may be filed or when
regulatory approvals may be received; and
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our
expectations of when commercial sales of our products may commence
and
when actual revenue from the product sales may be
received.
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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:
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the
inherent uncertainties of product development based on our new and
as yet
not fully proven technologies;
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the
risks and uncertainties regarding the actual effect on humans of
seemingly
safe and efficacious formulations and treatments when tested
clinically;
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the
inherent uncertainties associated with clinical trials of product
candidates;
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the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product candidates; and
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the
inherent uncertainties associated with commercialization of products
that
have received regulatory approval.
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Additional
factors that could affect future results are set forth below under Item
1A. Risk Factors.
We
caution investors that the forward-looking statements contained in this Report
must be interpreted and understood in light of conditions and circumstances
that
exist as of the date of this Report. We expressly disclaim any obligation or
undertaking to update or revise forward-looking statements made in this Annual
Report 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.
1
Part
I
Item
1. Business.
General
We
were
incorporated in Delaware in September 1997 for the purpose of acquiring Generex
Pharmaceuticals Inc., a Canadian corporation formed in November 1995 to engage
in pharmaceutical and biotechnological research and development and other
activities. Our acquisition of Generex Pharmaceuticals was completed in October
1997 in a transaction in which the holders of all outstanding shares of Generex
Pharmaceuticals exchanged their shares for shares of our common stock.
In
January 1998, we participated in a "reverse acquisition" with Green Mt. P.
S.,
Inc., an inactive Idaho corporation formed in 1983. As a result of this
transaction, our shareholders (the former shareholders of Generex
Pharmaceuticals) acquired a majority (approximately 90%) of the outstanding
capital stock of Green Mt., we became a wholly-owned subsidiary of Green Mt.,
Green Mt. changed its corporate name to Generex Biotechnology Corporation
("Generex Idaho"), and we changed our corporate name to GB Delaware, Inc.
Because the reverse acquisition resulted in our shareholders becoming the
majority holders of Generex Idaho, we were treated as the acquiring corporation
in the transaction for accounting purposes. Thus, our historical financial
statements, which essentially represented the historical financial statements
of
Generex Pharmaceuticals, were deemed to be the historical financial statements
of Generex Idaho.
In
April
1999, we completed a reorganization in which we merged with Generex Idaho.
In
this transaction, all outstanding shares of Generex Idaho were converted into
our shares, Generex Idaho ceased to exist as a separate entity, and we changed
our corporate name back to "Generex Biotechnology Corporation." This
reorganization did not result in any material change in our historical financial
statements or current financial reporting.
Subsidiaries
Following
our reorganization in 1999, Generex Pharmaceuticals Inc., which is incorporated
in Ontario, Canada, remained as our wholly-owned subsidiary. All of our Canadian
operations are performed by Generex Pharmaceuticals.
In
August
2003, we acquired Antigen Express, Inc. Antigen is engaged in the research
and
development of technologies and immunomedicines for the treatment of malignant,
infectious, autoimmune and allergic diseases.
We
formed
Generex (Bermuda), Inc., which is organized in Bermuda, in January 2001 in
connection with a joint venture with Elan International Services, Ltd., a
wholly-owned subsidiary of Elan Corporation, plc, to pursue the application
of
certain of our and Elan's drug delivery technologies, including our platform
technology for the buccal delivery of pharmaceutical products. In December
2004,
we and Elan agreed to terminate the joint venture. Under the termination
agreement, we retained all of our intellectual property rights and obtained
full
ownership of Generex (Bermuda). Generex (Bermuda) currently does not conduct
any
business activities.
We
formed
Generex Pharmaceuticals (USA) LLC, which is organized in North Carolina, USA,
in
February 2006 as a wholly-owned subsidiary. Generex Pharmaceuticals (USA) LLC
has not yet commenced any business operations. We formed Generex Marketing
&
Distribution Inc., which is organized in Ontario, Canada, in September 2006.
Generex Marketing & Distribution Inc. has not yet commenced any business
operations.
Overview
of Business
We
are
engaged primarily in the research, development and commercialization of drug
delivery systems and technologies. Our primary focus at the present time is
our
proprietary technology for the administration of formulations of large molecule
drugs to the oral (buccal) cavity using a hand-held aerosol applicator. Through
our wholly-owned subsidiary, Antigen, we have expanded our focus to include
immunomedicines incorporating proprietary vaccine formulations.
2
We
seek
to develop proprietary formulations of large molecule drugs that can be
administered through the buccal mucosa, primarily the inner cheek walls, thereby
eliminating or reducing the need for injections. All injection therapies involve
varying degrees of discomfort and inconvenience. With chronic and sub-chronic
diseases, the discomfort and inconvenience associated with injection therapies
frequently results in less than optimal patient acceptance of, and compliance
with, the prescribed treatment plan. Poor acceptance and compliance can lead
to
medical complications and higher disease management costs. Also, elderly, infirm
and pediatric patients with chronic or sub-chronic conditions may not be able
to
self-inject their medications. In such cases, assistance is required which
increases both the cost and inconvenience of the therapy.
We
believe that our buccal delivery technology is a platform technology that has
application to many large molecule drugs and provides a convenient,
non-invasive, accurate and cost-effective way to administer such drugs. We
have
identified several large molecule drugs as possible candidates for development,
including estrogen, heparin, monoclonal antibodies, human growth hormone and
fertility hormone, but to date have focused our development efforts primarily
on
one pharmaceutical product, Generex Oral-lyn™, an insulin formulation
administered as a fine spray into the oral cavity using our proprietary
hand-held aerosol spray applicator known as RapidMist™. Using our buccal
delivery technology, we have also launched a line of over-the-counter glucose
and energy sprays , including Glucose RapidSpray™, GlucoBreak™, and BaBOOM!™
Energy Spray.
Our
subsidiary, Antigen, concentrates on developing proprietary vaccine formulations
that work by stimulating the immune system to either attack offending agents
(i.e., cancer cells, bacteria, and viruses) or to stop attacking benign elements
(i.e., self proteins and allergens). Our immunomedicine products are based
on
two platform technologies and are in the early stages of development.
Development efforts are underway in breast cancer, prostate cancer, influenza
virus, avian influenza, HIV, smallpox, SARS and Type I diabetes mellitus. We
have established collaborations with clinical investigators at academic centers
to advance these technologies.
We
are a
development stage company although we have four products available for
commercial sale. In fiscal 2007, we received revenues from sales of only one
of
our commercially available products, our confectionary, Glucose RapidSpray™.
Glucose RapidSpray™, introduced in August 2006, is currently available in retail
stores and independent pharmacies in the United States and Canada. We recently
introduced in retail stores in the United States and Canada two other
over-the-counter glucose sprays using our proprietary delivery technology,
a
flavored glucose “energy” spray supplemented with vitamins, BaBOOM!™ Energy
Spray, and a fat-free glucose spray to aid in dieting, GlucoBreak™. In fiscal
2008, we expect to receive revenues from sales of our over-the-counter glucose
and energy sprays in the United States and Canada. We expect other distribution
territories for these products to include the Middle East, South Africa, India,
South America and other jurisdictions worldwide.
We
operate in only one segment: the research, development and commercialization
of
drug delivery systems and technologies for metabolic and immunological
diseases.
Buccal
Delivery Technology and Products
Our
buccal delivery technology involves the preparation of proprietary formulations
in which an active pharmaceutical agent is placed in a solution with a
combination of absorption enhancers and other excipients classified “generally
recognized as safe” ("GRAS") by the United States Food and Drug Administration
(the "FDA") when used in accordance with specified quantities and other
limitations. The resulting formulations are aerosolized with a pharmaceutical
grade chemical propellant and are administered to patients using our proprietary
RapidMist™ device. The device is a small, lightweight, hand-held, easy-to-use
aerosol applicator comprised of a container for the formulation, a metered
dose
valve, an actuator and dust cap. Using the device, patients self-administer
the
formulations by spraying them into the mouth. The device contains multiple
applications, the number being dependent, among other things, on the
concentration of the formulation. Absorption of the pharmaceutical agent occurs
in the buccal cavity, principally through the inner cheek walls. In clinical
studies of our flagship oral insulin product Generex Oral-lyn™, insulin
absorption in the buccal cavity has been shown to be very efficacious.
3
Buccal
Insulin Product - Generex Oral-Lyn™
Insulin
is a hormone that is naturally secreted by the pancreas to regulate the level
of
glucose, a type of sugar, in the bloodstream. The term “diabetes” refers to a
group of disorders that are characterized by the inability of the body to
properly regulate blood glucose levels. When glucose is abundant, it is
converted into fat and stored for use when food is not available. When glucose
is not available from food, these fats are broken down into free fatty acids
that stimulate glucose production. Insulin acts by stimulating the use of
glucose as fuel and by inhibiting the production of glucose. In a healthy
individual, a balance is maintained between insulin secretion and glucose
metabolism.
There
are
two major types of diabetes. Type 1 diabetes (juvenile onset diabetes or insulin
dependent diabetes) refers to the condition where the pancreas produces little
or no insulin. Type 1 diabetes accounts for 5-10 percent of diabetes cases.
It
often occurs in children and young adults. Type 1 diabetics must take daily
insulin injections, typically three to five times per day, to regulate blood
glucose levels.
In
Type 2
diabetes (adult onset or non-insulin dependent diabetes mellitus), the body
does
not produce enough insulin, or cannot properly use the insulin produced. Type
2
diabetes is the most common form of the disease and accounts for 90-95 percent
of diabetes cases. In addition to insulin therapy, Type 2 diabetics may take
oral drugs that stimulate the production of insulin by the pancreas or that
help
the body to more effectively use insulin.
Current
studies in Diabetes have identified a new condition closely related to diabetes,
called Impaired Glucose Tolerance (IGT). People with IGT do not usually meet
the
criteria for the diagnosis of diabetes mellitus. They have normal fasting
glucose levels but two hours after a meal their blood glucose level is far
above
normal.. With the increase use of glucose tolerance tests the number of people
diagnosed with this pre-diabetic condition is expanding
exponentially.
If
not
treated, diabetes can lead to blindness, kidney disease, nerve disease,
amputations, heart disease and stroke. Each year, between 12,000 and 24,000
people suffer vision impairment or complete blindness because of diabetes.
Diabetes is also the leading cause of end-stage renal disease (kidney failure),
accounting for about 40 percent of new cases.
In
addition, about 60-70 percent of people with diabetes have mild to severe forms
of diabetic nerve damage, which, in severe forms, can lead to lower limb
amputations. Diabetics are also two to four times more likely to have heart
disease, which is present in 75 percent of diabetes-related deaths, and are
two
to four times more likely to suffer a stroke.
There
is
no known cure for diabetes. The World Health Organization estimates that there
are currently over 180 million diabetics worldwide. It is further estimated
that
this number will almost double by the year 2030. There are estimated to be
18
million people suffering from diabetes in North America alone, not including
approximately 5 million of whom are undiagnosed, and diabetes is the second
largest cause of death by disease in North America.
A
substantial number of large molecule drugs (i.e.,
drugs
composed of molecules with a higher than specified molecular weight) have been
approved for sale in the United States or are presently undergoing clinical
trials as part of the process to obtain such approval, including various
proteins, peptides, monoclonal antibodies, hormones and vaccines. Unlike small
molecule drugs, which generally can be administered by various methods, large
molecule drugs historically have been administered predominately by injection.
The principal reasons for this have been the vulnerability of large molecule
drugs to digestion and the relatively large size of the molecule itself, which
makes absorption into the blood stream through the skin inefficient or
ineffective.
We
conducted the first clinical trials of our buccal insulin formulation with
human
subjects in Ecuador in January 1998. We ultimately conducted a total of
approximately 13 studies in Ecuador and an additional 26 trials in other
countries over the period from 1998 to 2007. Each of these trials involved
a
selection of between 8 and 20 patients and some of the patients were taking
our
oral insulin product for the period of twelve month. The principal purpose
of
these studies was to evaluate the effectiveness of our oral insulin formulation
in humans as well as to show safety and efficacy of our product compared with
injected insulin and placebos. In March 2004, we entered into a Letter of Intent
for the establishment of a joint venture with PharmaBrand S.A., a distributor
of
pharmaceutical products in Central and Latin America. In August 2004, we sought
approval for the manufacturing, marketing, distribution and sale of Generex
Oral-lyn™ and the RapidMist™ Diabetes Management System from the Ecuadorian
Ministry of Public Health. In May 2005, we received approval from the Ecuadorian
Ministry of Public Health for the commercial marketing and sale of Generex
Oral-lyn™ for treatment of Type 1 and Type 2 diabetes. We have successfully
completed of the delivery and installation of a turnkey Generex Oral-lyn™
filling operation at the facilities of PharmaBrand in Quito, Ecuador. The first
commercial production run of Generex Oral-lyn™ in Ecuador was completed in May,
2006.
4
Our
business partner for the commercialization of Generex Oral-lyn™ in Latin
America, PharmaBrand, was responsible for the commercial sales of Generex
Oral-lyn™ in Ecuador upon launch in 2006. We are in the process of refining our
relationship with PharmaBrand to transition their role to primarily that of
a
manufacturer for the commercial orders placed worldwide. We expect additional
commercial manufacturing runs of the product at its facilities in Quito, Ecuador
in the second half of calendar year 2007. In addition, PharmaBrand will continue
its marketing and sales efforts in Ecuador in 2008 with a focus towards the
IGT
population.
On
the
basis of the test results in Ecuador and other pre-clinical data, we made an
Investigatory New Drug submission to the Health Protection Branch in Canada
(Canada's equivalent to the FDA) in July 1998, and received permission from
the
Canadian regulators to proceed with clinical trials in September 1998. We filed
an Investigational New Drug application with the FDA in October 1998, and
received FDA approval to proceed with human trials in November 1998. Annual
reports have been filed with the FDA each year since that time.
We
began
our clinical trial programs in Canada and the United States in January 1999.
Between January 1999 and September 2000, we conducted clinical trials of our
insulin formulation involving approximately 200 Type 1 and Type 2 diabetic
patients and healthy volunteers. The study protocols in most trials involved
administration of two different doses of our insulin formulation following
either a liquid Sustacal meal or a standard meal challenge. The objective of
these studies was to evaluate our insulin formulation's efficacy in controlling
post-prandial (meal related) glucose levels. These trials demonstrated that
our
insulin formulation controlled post-prandial hyperglycemia in a manner
comparable to injected insulin. In April 2003, a Phase II-B clinical trial
protocol was approved in Canada. In September 2006, a Clinical Trial Application
relating to our Generex Oral-lyn™ protocol for late-stage trials was approved by
Health Canada. The FDA’s review period for the protocol also recently lapsed
without objection.
The
preparation for the Phase III clinical trials for Generex Oral-lyn ™ has already
commenced. The key vendors for the management of the Phase III program have
already been identified and some of the formal Clinical Trial Agreements have
been executed. A number of centers for the Phase III clinical studies have
also
been chosen in the United States, Canada, Europe and Eastern Europe including
Russia, Ukraine, Romania, Bulgaria, and Poland. The six-month trial with the
six-month follow-up is expected to include 750 patients with Type 1 diabetes
mellitus. Patient enrollment is expected to begin at some of the sites during
the fourth quarter of calendar year 2007 and expand to several global centers
over the course of the study. The primary objective of the study is to compare
the efficacy of Generex Oral-lyn™ and the RapidMist™ Diabetes Management System
with that of standard regular injectable human insulin therapy as measured
by
HbA1c, in patients with Type-1 diabetes mellitus. We expect to use the data
collected from these trials in the New Drug Submission that will be prepared
concurrently with the progression of the late-stage trials for Health Canada,
European Union (EMEA) and the FDA. We have engaged a global Clinical Research
Organization to provide many study related site services including initiation,
communication with sites and documentation; a global central lab service company
that will arrange for the logistics of kits and blood samples shipment and
an
Internet-based clinical data management company to assist us with global project
management of the Phase III clinical trial and regulatory processes. In
anticipation of undertaking such trials, we have secured a manufacturer to
produce clinical trial batches of Generex Oral-lyn™.
5
Buccal
Glucose and Energy Products - Glucose RapidSpray™, BaBOOM! ™ Energy Spray and
GlucoBreak™
Using
our
proprietary buccal delivery technology, we have developed several formulations
of glucose sprays that are available over-the-counter. In the first quarter
of
fiscal year 2007, we introduced, Glucose RapidSpray™. This product uses our
proprietary RapidMist™ platform technology to provide an alternative for people
who require or want additional glucose in their diet and delivers a fat-free,
low-calorie glucose formulation directly into the mouth. Glucose RapidSpray™ is
currently available in the United States and Canada through a number of leading
retail chains and online. It is to be available in a total of 15 countries
in
the Middle East, South Africa and expected to expand in other markets in
2008.
Glucose
RapidSpray™ offers another aid to diabetics who require or need additional
glucose to their diets or daily intake.. Recent studies conducted by scientists
at the University Campus Bio-Medico, Rome, Italy in conjunction with Generex
have demonstrated that Glucose RapidSpray™ used early in the onset of a
hypoglycaemia episode can stop such an episode and prevent a further drop in
blood glucose and the noxious feelings that ensue. With our easy-to-use
RapidSpray™ bottle, individuals can easily add additional glucose to their diets
and serves as a medium for first signs of low blood sugar levels.
We
believe that we can market Glucose RapidSpray™ as a complementary product
Generex Oral-lyn™. We believe that a combination therapy of Generex Oral-lyn™,
Glucose RapidSpray™ and other oral agents, including a metformin gum which we
are jointly developing with Fertin Pharma A/S, could provide a full range of
products used in the treatment of Type-2 diabetes and people with Impaired
Glucose Tolerance (IGT).
In
the
fourth quarter of fiscal year 2007, we expanded our line of over-the-counter
products using our proprietary RapidSpray™ delivery device with the introduction
of two new products. GlucoBreak™ is a fat-free glucose spray that is marketed as
an aid for dieters and can be used between meals as part of a daily diet
routine, during exercise and before bedtime. GlucoBreak™ is the first product
related to weight loss that we have launched.
A
separate study also conducted by scientists at the University Campus Bio-Medico,
Rome, Italy had demonstrated that delivery of small amounts of glucose during
the day appeared to reduce the body mass index of subjects using GlucoBreak
™ as
compared to a control group. Such a benefit may be of benefit individuals with
obesity and diabetes. It is estimated that there are over 70 million dieters
in
the United States, the majority of whom try to lose weight by
themselves.
Our
other
new product, BaBOOM!™ Energy Spray is a convenient and pleasant-tasting instant
energy spray designed to enhance energy levels for sports, work, study, travel
and overall fatigue. Its primary ingredients include glucose, caffeine, ginseng
and Vitamins B and C. It is fat-free, has fewer than five calories per serving
and is available in watermelon flavor. BaBOOM! ™ Energy Spray is our first
energy product.
Currently,
BaBOOM!™ Energy Spray and GlucoBreak™ are being considered for commercial sale
in several of the largest national and regional retailers and drug store chains
in the United States and Canada. Glucose RapidSpray™ is currently being marketed
in the Middle East through the Master Distributor Agreement with Leosons General
Trading Company and in South Africa and six neighboring countries trough the
Master Distributor Agreement with Adcock Ingram LLP and Adcock Ingram Healthcare
(Pty) Ltd.. We expect to expand to other markets in 2008.
The
strategy to develop and launch these over-the-counter products are threefold.
The first is to demonstrate the expansion of our proprietary RapidSpray ™
technology. The second is to create a brand name in the marketplace particularly
in the diabetes shelf space with Glucose RapidSpray ™ and GlucoBreak ™ and on a
mainstream scale with BaBOOM! ™ Energy Spray. Finally, the product pipeline
provides us with an additional revenue stream while we attain registrations
and
approvals worldwide for our oral insulin product.
Metformin
Gum Product/Strategic Alliance
In
May
2006, we established a collaborative alliance with Fertin Pharma A/S, a leading
Danish manufacturer of medicinal chewing gum, for the development of a metformin
medicinal chewing gum for the treatment of Type-2 diabetes mellitus and obesity.
Metformin is a generic drug used to regulate blood glucose levels by reducing
the amount of glucose produced by the liver, reducing the amount of glucose
absorbed from food in the stomach, and by making the insulin produced by the
body work more effectively to reduce the amount of glucose already in the blood.
It is an important staple of the standard of care for patients with Type-2
diabetes mellitus.
6
Through
this collaborative relationship, we will seek to combine our proprietary buccal
drug delivery platform technologies with Fertin's know-how related to gum base
formulations, solubilization systems, and taste masking/modification to create
a
metformin medicinal chewing gum that will deliver metformin into the body via
the buccal mucosa rather than in its current tablet form. We anticipate that
this delivery method, in addition to being much more rapid and providing a
much
more specific and effective dosing regimen, could avoid some of the adverse
side
effects associated with taking metformin in tablet form, such as nausea,
vomiting, abdominal pain, diarrhea, abdominal bloating, and increased gas
production. In addition, metformin gum could avoid the bitter taste and large
doses associated with the tablet form and thus improve therapeutic compliance,
particularly among younger patients.
The
initial product samples have been developed for test marketing prior to clinical
batch. We anticipate that we will conduct a clinical study in Canada in the
spring of 2008 to establish bioequivalence with a Canadian Reference
Product. This will encompass the preparation and submission of a Clinical
Trial Application (“CTA”) to Health Canada, the authorization to proceed, and
the actual execution of the clinical study, which we estimate will be completed
in the third or fourth quarter of our 2008 fiscal year. Once completed, we
anticipate that an Abbreviated New Drug Submission with full support data will
be prepared and submitted to Health Canada, where we will be seeking regulatory
approval/authorization for the manufacturing, marketing, and sale of the
product. A pre-CTA meeting may be initiated to provide Health Canada with
the Study plans and receive concurrence of our initiatives. We expect to conduct
similar regulatory activities in the U.S., Europe and other strategic markets
within an 18 - 24 month period.
If
we
successfully develop the metformin medicinal chewing gum, we would market it
as
a companion product to Generex Oral-lyn™. We believe that a combination therapy
of Generex Oral-lyn™, metformin gum, and other traditional oral agents could
optimize the treatment of Type-2 diabetes and, possibly, delay the onset of
certain complications associated with diabetes.
Potential
Buccal Morphine and Fentanyl Products
The
delivery of morphine and fentanyl by oral formulation (pills) and injection
for
the treatment of moderate to severe breakthrough and postoperative pain often
fails to provide patients with adequate relief and control because, among other
reasons, breakthrough and postoperative pain are characterized as being moderate
to severe in intensity and have a rapid onset of action and a short to medium
duration. Not only does delivery by pills have a slow onset of action, it is
often difficult for patients to adjust their doses, with the result that
patients are either over or under medicated. Injections are invasive and require
an attendant to administer the medication which reduces the patient's control
over the pain and may cause increased anxiety. We believe that a buccal delivery
formulation for morphine and fentanyl would have a critical series of attributes
well suited for the treatment of breakthrough and post operative pain, would
be
cost-effective and would have a demonstrable improvement over current delivery
methods, including fast access to the circulatory system, precise dosing control
and a simple, self-administration procedure.
We
made
an Investigatory New Drug submission for buccal morphine to the Health
Protection Branch in Canada in January 2002, and received permission from the
Canadian regulators to proceed with clinical trials in March 2002. We made
an
Investigatory New Drug submission for fentanyl to the Health Protection Branch
in Canada in August 2002, and received permission from the Canadian regulators
to proceed with clinical trials in October 2002. During fiscal year ended July
31, 2007, we did not actively pursue our buccal morphine and buccal fentanyl
projects. The development of these products will most likely be delayed while
the company focuses on late stage trials of the oral insulin formulation in
the
United States, Canada and Europe.
Other
Potential Buccal Products
We
have
had discussions of possible research collaborations with various pharmaceutical
companies concerning use of our large molecule drug delivery technology with
other compounds, including monoclonal antibodies, human growth hormone,
fertility hormone, estrogen and heparin, and a number of vaccines. We have
not
aggressively pursued development opportunities apart from insulin because we
believe it is more advantageous to concentrate our resources, particularly
our
financial resources, on commercializing the insulin product.
7
Immunomedicine
Technology and Products
Our
wholly-owned subsidiary Antigen is developing proprietary vaccine formulations
based upon two platform technologies that were discovered by its founder, the
Ii-Key hybrid peptides and Ii-Suppression. These technologies are applicable
for
either antigen-specific immune stimulation or suppression, depending upon the
dosing and formulation of its products. Using active stimulation, we are
focusing on major diseases such as breast and prostate cancer, H5N1 avian
influenza and HIV. Autoimmune disease such as diabetes, multiple sclerosis
and
allergic asthma are the focus of our antigen-specific immune suppression work.
Antigen’s
immunotherapeutic vaccine AE37 is currently in Phase II clinical trials for
patients with HER-2/neu positive breast cancer. The trial is being conducted
with the United States Military Cancer Institute's (USMCI) Clinical Trials
Group
and will examine the rate of relapse in patients with node-positive or high-risk
node-negative breast cancer after two years. The study is randomized and will
compare patients treated with AE37 plus the adjuvant GM-CSF versus GM-CSF alone.
The Phase II trial follows a Phase I trial that demonstrated safety,
tolerability, and immune stimulation of the AE37 vaccine in breast cancer
patients.
Based
on
positive results in trials of the AE37 vaccine in breast cancer patients, we
entered into an agreement in August 2006 with the Euroclinic, a private center
in Athens, Greece, to commence clinical trials with the same compound as an
immunotherapeutic vaccine for prostate cancer. We expect that the new prostate
cancer studies will involve 30 patients and will evaluate primarily
immunological responsiveness to a dose of the vaccine previously shown to be
well tolerated in breast cancer patients. These studies are currently underway.
The
same
technology used to enhance immunogenicity is being applied in the development
of
a synthetic peptide vaccine for H5N1 avian influenza. In April 2007, a Phase
I
clinical trial of Antigen’s proprietary peptides derived from the hemagglutinin
protein of the H5N1 avian influenza virus was initiated in healthy volunteers
in
the Lebanese-Canadian Hospital in Beirut, Lebanon. We anticipate that the trial
will be completed by the fall of 2008. Modified peptide vaccines for avian
influenza offer several advantages over traditional egg-based or cell-culture
based vaccines. Modified peptide vaccines can be manufactured by an entirely
synthetic process which reduces cost and increases both the speed and quantity
of production egg- or cell-culture based vaccines. Another advantage is that
the
peptides are derived from regions of the virus that are similar enough in all
H5N1 virus strains such that they would not have to be newly designed for the
specific strain to emerge in a pandemic.
In
March
2007, Antigen entered into an agreement with Beijing Daopei Hospital in Beijing,
China to conduct clinical trials using Antigen’s pioneering technology for RNA
interference (RNAi) stimulation of the immune response against patients’ immune
cells. The strategy developed by Antigen involves modifying the patient's cancer
cells to increase their immunogenicity and thereby enable the immune system
to
fight off the cancer anywhere in the patient's body. Antigen has developed
proprietary methods using RNAi to specifically inhibit expression of the Ii
protein in cancer cells already expressing MHC class II molecules that are
amenable to clinical use. Cancer cells from patients with acute myelogenous
leukemia will be transfected with a vector expressing RNAi to silence Ii
expression. After lethal irradiation, the cells are re-introduced as a
subcutaneous immunization to the patient. The
trial
is expected to commence after stabilization of regulatory affairs in the
region.
We
have
filed a Physician’s Investigational New Drug application for the Phase I and
Phase II trials in patients with stage II HER-2/neu positive breast cancer.
Applications were filed and approvals obtained for Phase I prostate cancer
using
AE37 in Athens, Greece from the Hellenic Organization of Drugs. The Ministry
of
Health in Lebanon gave approval for Phase I trial of our experimental H5N1
prophylactic vaccine in Beirut, Lebanon following submission of an application.
All other immunomedicine products are in the pre-clinical stage of development.
8
Government
Regulation
Our
research and development activities and the manufacturing and marketing of
our
pharmaceutical products are subject to extensive regulation by the FDA in the
United States, Health Protection Branch in Canada and comparable regulatory
authorities in other countries. Among other things, extensive regulation puts
a
burden on our ability to bring products to market. While these regulations
apply
to all competitors in our industry, many of our competitors have more experience
in dealing with the FDA and other regulators. Also, other companies in our
industry are not limited primarily to products which still need to be approved
by government regulators, as we are now.
If
requisite regulatory approvals are not obtained and maintained, our business
will be substantially harmed. In many cases, we expect that extant and
prospective development partners will participate in the regulatory approval
process. The following discussion summarizes the principal features of food
and
drug regulation in the United States and other countries as they affect our
business.
United
States
All
aspects of our research, development and foreseeable commercial activities
relating to pharmaceutical products are subject to extensive regulation by
the
FDA and other regulatory authorities in the United States. United States federal
and state statutes and regulations govern, among other things, the testing,
manufacturing, safety, efficacy, labeling, storage, record keeping, approval,
advertising and promotion of pharmaceutical products. The regulatory approval
process, including clinical trials, usually takes several years and requires
the
expenditure of substantial resources. If regulatory approval of a product is
granted, the approval may include significant limitations on the uses for which
the product may be marketed.
The
steps
required before a pharmaceutical product may be marketed in the United States
include:
·
|
Quality
test/studies;
|
|
|
·
|
pre-clinical
tests /studies;
|
|
|
·
|
submission
to the FDA of Investigational New Drug Applications (“INDs”) and/or
Amendments for each planned human clinical trial;
|
|
|
·
|
FDA
acceptance of INDs, which permit human clinical trials to
commence;
|
|
|
·
|
commencement
and completion of numerous human clinical trials to establish the
safety
and efficacy of the subject drug;
|
|
|
·
|
submission
of a New Drug Application to the FDA; and
|
|
|
·
|
FDA
approval of the New Drug Application, including approval of all product
labeling
|
Quality
and pre-clinical tests and studies include: laboratory evaluation of Drug
Substance and Drug Product chemistry, formulation/manufacturing, and stability
profiling, as well as a large number of animal studies to assess the potential
safety and efficacy of each product. Typically, the pre-clinical studies consist
of the following:
Pharmacology
· |
Primary
and Secondary Pharmacodynamics
|
· |
Safety
Pharmacology
|
· |
Other
Pharmacodynamics
|
9
Pharmacokinetics
(“PK”)
· |
Single
and Multiple Dose Kinetics
|
· |
Tissue
Distribution
|
· |
Metabolism
|
· |
PK
Drug Interactions
|
· |
Other
PK studies
|
Toxicology
· |
Single
and Multiple Dose Toxicity
|
· |
Genotoxicity
|
· |
Carcinogenicity
|
· |
Reproduction
Toxicity
|
· |
Other
Toxicity
|
The
results of the quality and pre-clinical tests/studies, in addition to any
non-clinical pharmacology, are submitted to the FDA along with the initial
clinical study protocol (see descriptive of process below) as part of the
initial IND and are reviewed by the FDA before the commencement of human
clinical trials. Unless the FDA objects to it, the IND becomes effective 30
days
following its receipt by the FDA. Subsequent clinical studies may begin as
soon
as the protocols are submitted. FDA reviews all protocols, protocol amendments,
adverse event reports, study reports, and annual reports in connection with
a
new pharmacological product.
The
IND
for our oral insulin formulation became effective in November 1998. Amendments
are also subsequently filed as new Clinical Studies and their corresponding
Study Protocols are proposed. In July 2007, we received a no objection clearance
to initiate our Phase III study protocol for our oral insulin product. We filed
an Investigational New Drug Application for buccal morphine in January
2002. The Physician’s Investigational New Drug Application for the Phase 1
and Phase II trial of AE37, Antigen’s synthetic peptide vaccine designed to
stimulate a potent and specific immune response against tumors expressing the
HER-2/neu oncogene, in patients with stage II HER-2/neu positive breast cancer
became effective in March 2006.
Clinical
trials involve the administration of a new drug to humans under the supervision
of qualified investigators. The protocols for the trials must be submitted
to
the FDA as part of the IND. Also, each clinical trial must be approved and
conducted under the auspices of an Institutional Review Board (IRB), which
considers, among other things, ethical factors, the safety of human subjects,
and the possible liability of the institution conducting the clinical trials.
Clinical
trials are typically conducted in three sequential phases (Phase I, Phase II,
and Phase III), but the phases may overlap. Phase I clinical trials test the
drug on healthy human subjects for safety and other aspects, but not
effectiveness. Phase II clinical trials are conducted in a limited patient
population to gather evidence about the efficacy of the drug for specific
purposes, to determine dosage tolerance and optimal dosages, and to identify
possible adverse effects and safety risks. When a compound has shown evidence
of
efficacy and acceptable safety in Phase II evaluations, Phase III clinical
trials are undertaken to evaluate clinical efficacy and to test for safety
in an
expanded patient population at clinical trial sites in different geographical
locations. The FDA and other regulatory authorities require that the
safety and efficacy of therapeutic product candidates be supported through
at
least two adequate and well-controlled Phase III clinical trials (known as
“Pivotal Trials”). The successful completion of Phase III clinical trials
is a mandatory step in the approval process for the manufacturing, marketing,
and sale of products.
In
the
United States, the results of quality, pre-clinical studies and clinical trials,
if successful, are submitted to the FDA in a New Drug Application (“NDA”) to
seek approval to market and commercialize the drug product for a specified
use.
The NDA is far more specific than the IND and must also include proposed
labeling and detailed technical sections based on the data collected. The FDA
has 10 months to take an action for a standard application (and shorter for
a
priority application). It may deny a NDA if it believes that applicable
regulatory criteria are not satisfied. The FDA also may require additional
testing for safety and efficacy of the drug. We cannot be sure that any of
our
proposed products will receive FDA approval. The multi-tiered approval process
means that our products could fail to advance to subsequent steps without the
requisite data, studies, and FDA approval along the way. Even if approved by
the
FDA, our products and the facilities used to manufacture our products will
remain subject to review and periodic inspection by the FDA.
10
To
supply
drug products for use in the United States, foreign and domestic manufacturing
facilities must be registered with, and approved by, the FDA. Manufacturing
facilities must also comply with the FDA's current Good Manufacturing Practices
(cGMPs), and such facilities are subject to periodic inspection by the FDA.
Products manufactured outside the United States are inspected by regulatory
authorities in those countries under agreements with the FDA. To comply
with cGMPs, manufacturers must expend substantial funds, time and effort in
the
area of production and quality control. The FDA stringently applies its
regulatory standards for manufacturing. Discovery of previously unknown problems
with respect to a product, manufacturer or facility may result in consequences
with commercial significance. These include restrictions on the product,
manufacturer or facility, suspensions of regulatory approvals, operating
restrictions, delays in obtaining new product approvals, withdrawals of the
product from the market, product recalls, fines, injunctions and criminal
prosecution.
One
final
hurdle that is closely associated with the cGMP inspections is the Pre Approval
Inspection that FDA carries out prior to the issuance of a marketing license.
FDA inspectors combine cGMP compliance with a review of research and development
documents that were used in the formal New Drug Application. A close inspection
of historic data is reviewed to confirm data and to demonstrate that a company
has carried out the activities as presented in the New Drug Application. This
is
generally a long inspection and requires a team of individuals from the company
to “host” the FDA inspector(s).
Foreign
Countries
Before
we
are permitted to market any of our products outside of the United States, those
products will be subject to regulatory approval by foreign government agencies
similar to the FDA. These requirements vary widely from country to
country. Generally, however, no action can be taken to market any drug product
in a country until an appropriate application has been submitted by a sponsor
and approved by the regulatory authorities in that country. Again, similar
to
the FDA, each country will mandate a specific financial consideration for the
Marketing Application dossiers being submitted. Although an important
consideration, FDA approval does not assure approval by other regulatory
authorities. The current approval process varies from country to country, and
the time spent in gaining approval varies from that required for FDA approval.
The Canadian regulatory process is substantially similar to that of the United
States. We obtained regulatory approval to begin clinical trials of our oral
insulin formulation in Canada in November 1998. We obtained regulatory approval
to begin clinical trials of our buccal morphine product in Canada in March
2002. In April 2003, we received approval of an Oral-lyn™ Phase II-B
clinical trial protocol in Canada. We received regulatory approval to
begin clinical trials of our fentanyl product in Canada in October 2002.
In May 2005, we received approval from the Ecuadorian Ministry of Public Health
for the commercial marketing and sale of Generex Oral- lyn™ for treatment of
Type 1 and Type 2 diabetes. In September 2006 Health Canada approved our
Clinical Trial Application in respect of our proposed Generex Oral-lyn™ protocol
for late-stage trials; we expect to use the data collected from these trials
in
the New Drug Submission that will be prepared concurrently with the progression
of the late-stage trials.
Applications
were filed and approvals obtained for Phase I prostate cancer using AE37 in
Athens, Greece from the Hellenic Organization of Drugs. The Ministry of Health
in Lebanon gave approval for Phase I trial of our experimental H5N1 prophylactic
vaccine in Beirut, Lebanon following submission of an application.
Marketing
and Distribution
We
market
our products through collaborative arrangements with companies that have
well-established pharmaceutical marketing and distribution capabilities.
11
PharmaBrand,
our business partner for the commercialization of Generex Oral-lyn™ in Latin and
South America, has generated some commercial sales of the product in Ecuador
to
date. Currently, our relationship with PharmaBrand is governed by a letter
of
intent, and we are in the process of refining our relationship with PharmaBrand
to transition their role to primarily that of a manufacturer for the commercial
orders placed worldwide. In addition, PharmaBrand will continue its marketing
and sales efforts in Ecuador in 2008 with a focus towards the population with
Impaired Glucose Tolerance. We expect to receive revenues from such sales
sometime in 2008, but we do not expect that such sales will be reflected in
our
financial statements until we have entered into a definitive agreement with
PharmaBrand. We also recently entered into a licensing and distribution
agreement with a multinational distributor to initiate the regulatory approval
and commercialization process for Generex Oral-lyn™ in 15 Middle Eastern
countries. In July 2007, we also entered into a licensing and distribution
agreement with the Armenian Development Agency and the Canada Armenia Trading
House Ltd. for the commercialization of Generex Oral-lyn™ in the Republic of
Armenia, Georgia and the Republic of Kazakhstan. Under both of these agreements,
we will not receive an upfront license fee, but the distributor will bear any
and all costs associated with the procurement of governmental approvals for
the
sale of Generex Oral-Lyn™, including any clinical and regulatory costs. We
possess the worldwide marketing rights to our oral insulin product.
We
have
entered into distribution agreements with Cardinal Health, AmerisourceBergen
Corporation and McKesson Canada for the distribution of Glucose RapidSpray™ in
retail stores in the United States and Canada. Glucose RapidSpray™ is currently
sold in the United States and Canada through a number of leading retail chains,
including Amerimark Direct, Butler Drug Store, DIK Drug Co., Fruth Pharmacy,
H.D. Smith Wholesale Drug, Hy-Vee Inc., Kerr Drug Inc., Kinney Drug, Inc.,
Kinray Inc., Meijer, Smith Drug Company, ShopKo, Weiss Markets Inc., Value
Drug
Company, RDC, Aurora Pharmacy, Bainder International Drug Stores, Kohl &
Frisch Limited, Shoppers Drug Mart and UniPharm Wholesale Drugs Ltd. Glucose
RapidSpray™ is also available for sale on the Internet through Amazon.com,
Walgreens.com and DiabeticExpress.com. We are also seeking to expand our
distribution network in other markets around the world for our over-the-counter
line of products. As a result of this effort, Glucose RapidSpray™ is currently
being marketed in the Middle East through the Master Distributor Leosons General
Trading Company.
We
have
also established relationships with brokers who serve as a liaison to retail
outlets throughout the U.S. and Canada. These brokers represent multiple
products that are presented to specific product buyers. We believe that our
relationships with the brokers will place us in a stronger position to get
our
products listed and on the shelf in major chains throughout the United States
and Canada.
Our
newly
introduced over-the-counter glucose and energy spray products, BaBOOM!™ Energy
Spray and GlucoBreak™, are being reviewed for commercial sale in several of the
largest national and regional retailers and drug store chains in the United
States and Canada. We are also seeking to expand distribution of these products
in other countries.
Recently,
we have begun limited direct marketing of our glucose sprays on the Internet
and
have established web sites for each of Glucose RapidSpray™, BaBOOM!™ Energy
Spray and GlucoBreak™ where consumers may purchase these products directly.
With
respect to marketing all of our products, we intend to rely primarily on
contracting or collaborative arrangements with other companies that possess
strong pharmaceutical marketing and distribution resources to perform these
functions for us. Accordingly, we may not have the same control over marketing
and distribution that we would have if we conducted these functions ourselves.
Manufacturing
In
December 2000, we completed our pilot manufacturing facility for Generex
Oral-lyn™ in Toronto, Canada in the same commercial complex in which our
laboratories are located. In the first quarter of fiscal year 2006, we initiated
a scale-up commercial production run of several thousand canisters of Generex
Oral-lyn™ at this facility. We will need to significantly increase our
manufacturing capability or engage contract manufacturers in order to
manufacture any product in significant commercial quantities.
In
March
2006, we successfully completed of the delivery and installation of a turnkey
Generex Oral-lyn™ filling operation at the facilities of PharmaBrand, S.A. in
Quito, Ecuador for the purposes of commercial supply and sales in Ecuador and
other countries that can procure registrations and import licenses. We
anticipate that the capacity of this facility will be sufficient to support
commercial sales in Ecuador, other countries in Latin America and around the
world.
12
In
anticipation of undertaking late-stage clinical trials of Generex Oral-lyn™ in
Canada, we entered into an agreement with Cardinal Health PTS, LLC, now known
as
Catalent Pharma Solutions, in June 2006, pursuant to which Catalent will
manufacture clinical trial batches of Generex Oral-lyn™. Pursuant to pre-extant
supply arrangements, our third-party suppliers have been manufacturing the
quantities of the RapidMist™ device components (valves, canisters, actuators,
and dust caps), the insulin, and the formulary excipients that will be required
for the Catalent production. In addition, our Regulatory Affairs, Quality
Control and R&D personnel have been working with Catalent to prepare and
validate the Catalent production processes.
Our
subsidiary Antigen leases office and laboratory space in Worcester,
Massachusetts, which is sufficient for its present needs. The laboratory has
permission to store and use biohazardous (including recombinant DNA materials)
and flammable chemicals.
Our
over-the-counter glucose and energy products in Canada are manufactured by
Pax-All Manufacturing, Inc., contract manufacturing company with the emphasis
on
over-the-counter and personal care products. The products are manufactured
at
Pax-All’s manufacturing facility located in Mississauga, Canada.
Raw
Material Supplies
The
excipients used in our formulation are available from numerous sources in
sufficient quantities for clinical purposes, and we believe that they will
be
available in sufficient quantities for commercial purposes when required,
although we have not yet attempted to secure a guaranteed commercial supply
of
any such products. Components suitable for our RapidMist™ device are available
from a limited number of potential suppliers, as is the chemical propellant
used
in the device. The components which now comprise the device will be utilized
with the commercial version of our insulin product in Ecuador and other South
American countries, as well as the components for the commercial version of
our
new glucose spray products in the United States and Canada. We have secured
supply arrangements with manufacturers for each of the components and the
propellant that we presently use in our RapidMist™ device for commercial
quantities of such components. All such suppliers are prominent, reputable
and
reliable suppliers to the pharmaceutical industry. Because we now have a single
supplier for each of these components and propellant, however, we are more
vulnerable to supply interruptions than would be the case if we had multiple
suppliers for each component. We do not believe that the risk of supply for
proprietary raw materials or device components is unusual in the pharmaceutical
industry.
Insulin
is available worldwide from only a few sources. However, alternative supplies
of
insulin are under development. We currently procure recombinant human insulin
crystals for clinical trials and commercial production in Ecuador from time
to
time from a European supplier whose production facility is GMP certified by
the
FDA and European health authorities. We are working towards the establishment
of
a guaranteed long-term supply arrangement with this supplier. We are also
exploring potential alternative sources of supply. We also believe future
development and marketing partners under licensing and development agreements,
if any, will provide, or assist us to obtain, pharmaceutical compounds that
are
used in products covered under such agreements.
Components
used in the production of our over-the-counter glucose sprays products,
including glucose and all excipients, are available from a number of potential
suppliers. We have not secured commercial supply agreements with any of them
as
they are readily available in the commercial quantities.
While
morphine is a controlled substance, it is readily available for use in clinical
trials. We currently have the appropriate licenses and facilities for acquiring
and storing morphine in Canada. Various regulatory issues surround the import
of
morphine into the United States, and we will need to address these issues prior
to commencing clinical trials in the United States.
13
Raw
materials for our pre-clinical development stage immunomedicine products include
amino acids (for peptide therapeutics) and oligonucleotides (for genetic
constructs). These materials are readily available from commercial suppliers.
We
utilize the services of several commercial laboratories for the manufacturing
of
our pre-clinical development stage immunomedicine products.
Intellectual
Property
We
hold a
number of patents in the United States and foreign countries covering our buccal
and other delivery technologies. We also have developed brand names and
trademarks for products in all areas. We consider the overall protection of
our
patent, trademark and other intellectual property rights to be of material
value
and acts to protect these rights from infringement.
Patents
are a key determinant of market exclusivity for most branded pharmaceutical
products. Protection for individual products or technologies extends for varying
periods in accordance with the expiration dates of patents in the various
countries. The protection afforded, which may also vary from country to country,
depends upon the type of patent, its scope of coverage and the availability
of
meaningful legal remedies in the country.
We
currently have twenty issued U.S. patents and two pending U.S. patent
application pertaining to aspects of buccal delivery technology including oral
administration of macromolecular formulations (including insulin) as well as
pain relief medications such as morphine and fentanyl. We currently hold
two issued Canadian patents and ten pending Canadian patent applications also
relating to aspects of buccal drug delivery technology. We also hold
eighty-seven issued patents and seventy-nine pending patent applications
covering our drug delivery technology, including our over-the-counter glucose
and energy spray products and metformin gum, in jurisdictions other than the
U.S. and Canada, including Japan, Mexico, Australia and several European
countries. We plan to continue to expand our patent portfolio for
additional products, formulations and device inventions. We also plan to expand
the territorial coverage of our existing patent portfolio and new additions
to
more markets around the world where we plan to do business.
In
addition, we have one issued Canadian patent, one U.S. patent and one pending
U.S. patent application pertaining to delivery technologies other than our
buccal delivery technology.
We
also
have an indirect interest in seven drug delivery patents held by another
company, Centrum Biotechnologies, Inc.
Our
subsidiary Antigen currently holds eight issued U.S. patents, three Australian
patents, four other foreign patents, six pending U.S. patent applications ,
2
pending U.S provisional patents and twenty eight foreign patent applications
concerning technology for modulating the immune system via activation of
antigen-specific helper T lymphocytes. Some of these patents are held under
exclusive licenses from the University of Massachusetts. Dr. Robert Humphreys,
a
retired officer of Antigen, and Dr. Minzhen Xu, an officer of Antigen, are
the
listed inventors or co-inventors on all of these patents and patent
applications, including those licensed from the University of
Massachusetts.
In
addition to patents, we hold intellectual property in the form of trademark
applications worldwide on products such as Generex Oral-lyn™. Trademarks have no
effect on market exclusivity for a product, but are considered to have marketing
value. Trademark protection continues in some countries as long as used; in
other countries, as long as registered. Registration is for fixed terms and
can
be renewed indefinitely.
We
possess the worldwide manufacturing and marketing rights to our oral insulin
product.
Our
long-term success will substantially depend upon our ability to obtain patent
protection for our technology and our ability to protect our technology from
infringement, misappropriation, discovery and duplication. We cannot be sure
that any of our pending patent applications will be granted, or that any patents
which we own or obtain in the future will fully protect our position. Our patent
rights and the patent rights of biotechnology and pharmaceutical companies
in
general, are highly uncertain and include complex legal and factual issues.
We
believe that our existing technology and the patents which we hold or for which
we have applied do not infringe any one else's patent rights. We believe our
patent rights will provide meaningful protection against others duplicating
our
proprietary technologies. We cannot be sure of this, however, because of the
complexity of the legal and scientific issues that could arise in litigation
over these issues. See Part
I - Item 3. Legal Proceedings
for a
discussion of certain legal proceedings involving intellectual property
issues.
14
We
also
rely on trade secrets and other unpatented proprietary information. We seek
to
protect this information, in part, by confidentiality agreements with our
employees, consultants, advisors and collaborators.
Competition
We
expect
that products based upon our buccal delivery technology and any other products
that we may develop will compete directly with products developed by other
pharmaceutical and biotechnology companies, universities, government agencies
and public and private research organizations.
Products
developed by our competitors may use a different active pharmaceutical agent
or
treatment to treat the same medical condition or indication as our product
or
may provide for the delivery of substantially the same active pharmaceutical
ingredient as our products using different methods of administration. For
example, a number of pharmaceutical and biotechnology companies are engaged
in
various stages of research, development and testing of alternatives to insulin
therapy for the treatment of diabetes, as well as new methods of delivering
insulin. These methods, including nasal, transdermal, needle-free (high
pressure) injection and pulmonary, may ultimately successfully deliver insulin
to diabetic patients. Some biotechnology companies also have developed different
technologies to enhance the presentation of peptide antigens. Some of our
competitors and potential competitors have substantially greater scientific
research and product development capabilities, as well as financial, marketing
and human resources, than we do.
Where
the
same or substantially the same active ingredient is available using alternative
delivery means or the same or substantially the same result is achievable with
a
different treatment or technology, we expect that competition among products
will be based, among other things, on product safety, efficacy, ease of use,
availability, price, marketing and distribution. When different active
pharmaceutical ingredients are involved, these same competitive factors will
apply to both the active agent and the delivery method.
We
consider other drug delivery and biotechnology companies to be direct
competitors for the cooperation and support of major drug and biotechnology
companies that own or market proprietary pharmaceutical compounds and
technologies, as well as for the ultimate patient market. Of primary concern
to
us are the competitor companies that are known to be developing delivery systems
for insulin and other pharmaceutical agents that we have identified as product
candidates and technologies to enhance the presentation of peptide antigens.
The
following descriptions of our competitors and their products were obtained
from
their filings with the Securities and Exchange Commission and/or information
available on their web sites.
Buccal
Insulin Product
Nektar
Therapeutics, formerly Inhale Therapeutic Systems, Inc. ("Nektar"), has
developed, in collaboration with Pfizer Inc., a customized insulin formulation
that is processed into a fine, dry powder and administered to the deep lung
using a proprietary inhalation device developed for this purpose. This product,
which is marketed as Exubera®, has been approved in the United States and the
European Union for the treatment of adults with Type 1 or Type 2 diabetes for
the control of high blood sugar levels. Since May 2006, Pfizer has launched
Exubera® in Germany, Ireland, the U.K. and in the U.S. Although initial supplies
of Exubera® were available across the U.S. beginning in September 2006, Pfizer
has expressed disappointment with its slow acceptance. Pfizer has devoted
additional resources to educating and marketing this product. In the U.S.,
Pfizer began branded direct-to-consumer advertising of Exubera® in print ads in
mid-June 2007 and television ads in July 2007. Pfizer also has been sued by
Novo
Nordisk, which claims that Exubera® infringes a patent now owned by Novo
Nordisk. A U.S. district court has denied a preliminary injunction that would
have blocked further sales of Pfizer’s inhalable insulin.
15
Nektar
and Pfizer are also collaborating on the development of a next generation
inhaled insulin device, which would have improved portability, convenience,
reliability and ease of use over Exubera®. On its own, Nektar is developing
pulmonary products with large molecule drugs other than insulin and has stated
that it is investigating the use of its inhalation technology with small
molecule drugs.
Aradigm
Corporation ("Aradigm") and Novo Nordisk A/S, which are collaborating on the
development of a pulmonary delivery system for insulin by inhalation, also
may
be considered our direct competitors. Novo Nordisk is one of the two leading
manufacturers of insulin in the world, the other being Eli Lilly and
Company. The AERx® insulin Diabetes Management System, or AERx iDMS,
initially developed by Aradigm, is currently in Phase III clinical trials which
began in May 2006. The Phase III clinical trials are expected to include a
total
of approximately 3,000 Type 1 and Type 2 diabetes patients. The trials include
treatment comparisons with other medicaments for the treatment of diabetes.
The
longest trial is expected to last 27 months. Novo Nordisk announced in
October 2006 that it expects the commercial launch of the product in 2010
with a second generation device that is significantly smaller and lighter than
its predecessor.
Other
companies have announced development efforts relating to non-injection methods
of delivering insulin or other large molecule drugs, including Alkermes Inc.,
which announced collaboration with Lilly in April 2000 to develop a pulmonary
method of administering insulin and is currently conducting Phase III clinical
trials. MannKind Corporation is developing an inhaled insulin product
named Technosphere™ Insulin, which is currently conducting Phase III clinical
trials in the United States and in Europe. Following its November 2006
acquisition of Kos Pharmaceuticals, Inc., Abbott Laboratories is expected to
continue development of Kos’ inhaled insulin product to complement Abbott’s
significant presence in the diabetes market. Bentley Pharmaceuticals, Inc.
is
developing its intranasal insulin product candidate, Nasulin™, and has concluded
a Phase IIA study of Nasulin in Type 1 diabetic patients and has advanced its
Phase IIA studies in the U.S. Bentley Pharmaceuticals Inc. has recently received
approval from the Drug Controller General of India (DCGI) to proceed with Phase
II trials of Nasulin™ in Type 2 diabetic patients. Nastech Pharmaceutical
Company Inc. recently started a Phase II clinical trial evaluating its insulin
nasal spray in Type 2 diabetics. Another
inhalable insulin product, QDose, developed in a joint venture between the
U.K.
firm Vectura and the U,S. company MicroDose Technologies, is in an early stage
of development, but has shown some encouraging results over Exubera®. Other
smaller companies, such as Emisphere Technologies, Inc., also are in various
stages of developing oral or buccal insulin formulations.
There
are
also a number of companies developing alternative means of delivering insulin
in
the form of oral pills, transdermal patches, and intranasal methods, which
are
at early stages of development.
In
addition to other delivery systems for insulin, there are numerous products
which have been approved for use in the treatment of Type 2 diabetics in
substitution of, or in addition to, insulin therapy. These products may also
be
considered competitive with insulin products.
Buccal
Morphine and Fentanyl Products
Cephalon,
Inc. currently markets Actiq® in the United States. Actiq® delivers buccal
transmucosal fentanyl to the cheek walls through the use of a lollipop. Barr
Laboratories, Inc. introduced a generic version of Actiq® in September 2006 in
the U.S. Cephalon received FDA approval in September 2006 for FENTORA™ and
launched the product in the United States shortly thereafter. FENTORA™ is a
fentanyl buccal tablet that is placed between the patient’s upper cheek and gum
and is indicated for the management of breakthrough pain in patients with cancer
who are already receiving and are tolerant to opioid therapy for their
underlying persistent cancer pain. Cephalon anticipates submitting a NDA to
the
FDA in late 2007 to expand the labeled indications for FENTORA™ to include
non-cancer breakthrough pain in opioid-tolerant patients. Other competing
products commonly prescribed to treat persistent pain are Johnson &
Johnson’s DURAGESIC® and Purdue Pharmaceuticals’ OXYCONTIN® and
MS-CONTIN®.
Nastech
Pharmaceuticals is developing an intranasal formulation of morphine that is
in
Phase II clinical trials. Results reported to date show the product to be
safe and efficacious in the treatment of episodes of breakthrough pain. Nastech
is currently seeking a licensing partner for this product.
16
Immunomedicine
Technology and Products
A
number
of companies that are engaged in the development of immunomedicines employ
technologies that are competitive to our subsidiary Antigen. The following
companies have initiated early stage clinical trials for several products for
the treatment of cancer, autoimmune, and allergic diseases. These companies
also
have established collaborations with academic centers and other companies for
the development of certain products. Zycos Inc. has developed the Biotope®
technology. Cel-Sci Corporation has developed the Ligand Epitope Antigen
Presentation System (L.E.A.P.S.) delivery technology. In April 2006, Cel-Sci
filed a provisional U.S. patent application covering CEL-1000, the lead product
developed from the L.E.A.P.S. technology, for the prevention/treatment of bird
flu and/or as an adjuvant to be included in a bird flu vaccine.
Pharmexa-Epimmune, a subsidiary of Pharmexa A/S, has developed the PADRE®
technology. Pharmexa, an international biotechnology company in the field of
active immunotherapy and vaccines for the treatment of cancer, serious chronic
and infectious diseases, is currently working on a conventional vaccine
targeting coat proteins, such as H5, using the Pharmexa-Epimmune PADRE®
technology. Pharmexa has announced that it plans to have one or more influenza
vaccine candidates ready for clinical development by the end of 2008.
Environmental
Compliance
Our
manufacturing, research and development activities involve the controlled use
of
hazardous materials and chemicals. We believe that our procedures for handling
and disposing of these materials comply with all applicable government
regulations. However, we cannot eliminate the risk of accidental contamination
or injury from these materials. If an accident occurred, we could be held liable
for damages, and these damages could severely impact our financial condition.
We
are also subject to many environmental, health and workplace safety laws and
regulations, particularly those governing laboratory procedures, exposure to
blood-borne pathogens, and the handling of hazardous biological materials.
Violations and the cost of compliance with these laws and regulations could
adversely affect us. However, we do not believe that compliance with the United
States, Canadian or other environmental laws will have a material effect on
us
in the foreseeable future.
Research
and Development Expenditures
A
substantial portion of our activities to date have been in research and
development. In the period from inception to July 31, 2007, our expenditures
on
research and development were $73,676,682. These included $11,983,626 in the
year ended July 31, 2007, $6,554,393 in the year ended July 31, 2006, and
$7,750,731 in the year ended July 31, 2005. The increase in our research and
development activities in 2007 compared to 2006 is due primarily to the
preparation for and the commencement of Phase III clinical trials of our oral
insulin product in Canada. The decrease in our research and development expenses
in 2006 compared to 2005 was due principally to reduced clinical trial
activities due to preparations for the Generex Oral-lyn™ Clinical Trial
Application in Canada.
Financial
Information About Geographic Areas
The
regions in which we had identifiable assets and revenues and the amounts of
such
identifiable assets and revenues for each of the last three fiscal years are
presented Note 17 in the Notes
to Consolidated Financial Statements
in
Part
II - Item. 8 Financial Statements and Supplementary Data
of this
Annual Report on Form 10-K. Identifiable assets are those that can be directly
associated with a geographic area.
Employees
At
September 30, 2007, we had twenty-five full-time employees, including our
executive officers and other individuals who work for us full-time but are
employed by management companies that provide their services, and ten employees
of our subsidiary Antigen. Eleven of our employees are executive and
administrative, eleven are scientific and technical personnel who engage
primarily in development activities and in preparing formulations for testing
and clinical trials, and three are engaged in corporate and product promotion
and product sales. We believe our employee relations are good. None of our
employees is covered by a collective bargaining agreement.
17
We
will
continue to need qualified scientific personnel and personnel with experience
in
clinical testing, government regulation and manufacturing. We may have
difficulty in obtaining qualified scientific and technical personnel as there
is
strong competition for such personnel from other pharmaceutical and
biotechnology companies, as well as universities and research institutions.
Our
business could be materially harmed if we are unable to recruit and retain
qualified scientific, administrative and executive personnel to support our
expanding activities, or if one or more members of our limited scientific and
management staff were unable or unwilling to continue their association with
us.
We have fixed-term agreements with only certain members of our key management
and scientific staff, including Anna Gluskin, our Chief Executive Officer and
President, Rose Perri, our Chief Operating Officer and Chief Financial Officer,
Mark Fletcher, our Executive Vice-President and General Counsel, Dr. Gerald
Bernstein, our Vice President Medical Affairs, Dr. Jaime Davidson, our Medical
Director, Eric von Hofe, our Vice-President Technology Development, Minzhen
Xu,
Vice-President Biology of Antigen, and Nikoletta Kallinteris, Senior Research
Associate.
We
use
non-employee consultants to assist us in formulating research and development
strategy, in preparing regulatory submissions, in developing protocols for
clinical trials, and in designing, equipping and staffing our manufacturing
facilities. We also use non-employee consultants to assist us in business
development. These consultants and advisors usually have the right to terminate
their relationship with us on short notice. Loss of some of these key advisors
could interrupt or delay development of one or more of our products or otherwise
adversely affect our business plans.
Executive
Officers and Directors
Name
|
|
Age
|
|
Position
Held with Generex
|
|
|
|
|
|
Anna
E. Gluskin
|
|
56
|
|
Chairman,
President, Chief Executive Officer and Director
|
|
|
|
|
|
Rose
C. Perri
|
|
40
|
|
Chief
Operating Officer, Chief Financial Officer, Treasurer, Secretary
and
Director
|
|
|
|
|
|
Gerald
Bernstein, M.D.
|
|
74
|
|
Director,
Vice President Medical Affairs
|
|
|
|
|
|
Mark
Fletcher, Esquire
|
|
41
|
|
Executive
Vice President and General Counsel
|
|
|
|
|
|
John
P. Barratt
|
|
63
|
|
Director
|
|
|
|
|
|
Brian
T. McGee
|
|
48
|
|
Director
|
|
|
|
|
|
Peter
G. Amanatides
|
|
43
|
|
Director
|
|
|
|
|
|
Nola
E. Masterson
|
|
61
|
|
Director
|
All
directors are elected to hold office until the next annual meeting of
stockholders following election and until their successors are duly elected
and
qualified. Executive officers are appointed by the Board of Directors and serve
at the discretion of the Board.
Anna
E. Gluskin:
Director since September 1997. Ms. Gluskin has served as the President and
Chief
Executive Officer of Generex since October 1997 and the Chairperson of the
Generex Board of Directors since November 2002. She held comparable positions
with Generex Pharmaceuticals Inc. from its formation in 1995 until its
acquisition by Generex in October 1997.
Rose
C. Perri.
Director since September 1997. Ms. Perri has served as Treasurer and Secretary
of Generex since October 1997 and as Chief Operating Officer since August 1998.
She served as Acting Chief Financial from November 2002 until April 2005 when
she was appointed Chief Financial Officer. She was an officer of Generex
Pharmaceuticals Inc. from its formation in 1995 until its acquisition by Generex
in October 1997.
18
Gerald
Bernstein, M.D.
Director since October 2002. Dr. Bernstein has served as Vice President Medical
Affairs of Generex since October 1, 2001. Dr. Bernstein acts as a key liaison
for Generex on medical and scientific affairs to the medical, scientific and
financial communities and consults with Generex under a consulting agreement
on
research and medical affairs and on development activities. Dr. Bernstein is
an
associate clinical professor at the Albert Einstein College of Medicine in
New
York and an attending physician at Beth Israel Medical Center, Lenox Hill
Hospital and Montefore Medical Center, all in New York. He was president of
the
American Diabetes Association from 1998 to 1999.
Mark
Fletcher, Esq.
Mr.
Fletcher has served as our Executive Vice President and General Counsel since
April 2003. From October 2001 to March 2003, Mr. Fletcher was engaged in the
private practice of law as a partner at Goodman and Carr LLP, a leading Toronto
law firm. From March 1993 to September 2001, Mr. Fletcher was a partner at
Brans, Lehun, Baldwin LLP, a law firm in Toronto. Mr. Fletcher received his
LL.B. from the University of Western Ontario in 1989 and was admitted to the
Ontario Bar in 1991.
John
P. Barratt.
Independent Director since March 2003. Mr. Barratt is currently the Chairman
of
the Generex Compensation Committee and the Corporate Governance and Nominating
Committee and a member of the Generex Audit Committee. Mr. Barratt currently
serves as the Board Liaison Officer of The Caldwell Partners International,
a
role he commenced in July 2006. From April 2005 to July 2006, Mr. Barratt served
as Chief Operating Officer of The Caldwell Partners International. The Caldwell
Partners International is a Canadian-based human capital professional services
company. Mr. Barratt from January 2002 until February 2007 served as the
court-appointed Responsible Person and Liquidation Manager of Beyond.com
Corporation, Debtor-in-Possession, a U.S. Chapter 11 Bankruptcy case, in which
capacity Mr. Barratt reported to the bankruptcy court and to the U.S. Trustee’s
Office. From September 2000 to January 2002, Mr. Barratt acted in the capacity
of Chief Operating Officer of Beyond.com Corporation, an electronic fulfillment
provider. Between 1996 and 2000, Mr. Barratt was partner-in-residence with
the
Quorum Group of Companies, an international investment partnership specializing
in providing debt and/or equity capital coupled with strategic direction to
emerging technology companies. Between 1988 and 1995, Mr. Barratt held a number
of positions with Coscan Development Corporation, a real estate development
company, the last position of which was Executive Vice-President and Chief
Operating Officer. Mr. Barratt currently serves on a number of Boards of
Directors, including Brascade Corporation and BAM Split Corporation, and is
a
member of the Board of Directors and Chairman of the Risk Policy Committee
of
the Bank of China (Canada). Mr. Barratt also serves on the Advisory Boards
of
the following Brascan SoundVest funds: Diversified Income Fund, Total Return
Fund, Rising Distribution Split Trust and Focused Business Trust. In addition,
Mr. Barratt is also a member of the Advisory Board of the Brascan Adjustable
Rate Trust I and Crystal Fountains Inc.
Brian
T. McGee.
Independent Director since March 2004. Mr. McGee is currently the Chairman
of
the Generex Audit Committee. Mr. McGee has been a partner of Zeifman &
Company, LLP ("Zeifman") since 1995. Mr. McGee began working at Zeifman shortly
after receiving a B.A. degree in Commerce from the University of Toronto in
1985. Zeifman is a Chartered Accounting firm based in Toronto, Ontario. A
significant element of Zeifman's business is public corporation accounting
and
auditing. Mr. McGee is a Chartered Accountant. Throughout his career, Mr. McGee
has focused on, among other areas, public corporation accounting and auditing.
In 1992, Mr. McGee completed courses focused on International Taxation and
Corporation Reorganizations at the Canadian Institute of Chartered Accountants
and in 2003, Mr. McGee completed corporate governance courses on compensation
and audit committees at Harvard Business School. In April 2004 Mr. McGee
received his CPA designation from The American Institute of Certified Public
Accountants.
Peter
G. Amanatides.
Independent Director since April 2005. Mr. Amanatides has been working in the
pharmaceutical and biotechnology industry since 1988. Since November 2004,
Mr.
Amanatides has been President and Chief Operating Officer of Pharmalogika,
Inc.,
a North Carolina-based service provider for the pharmaceutical and biotechnology
industry. Since April 2002, Mr. Amanatides has held the positions of Director
and Vice President within the Quality Organization for DSM Pharmaceuticals
and
DSM Biologics, both divisions of DSM Pharmaceutical Products, Inc. From February
1999 to April 2002, Mr. Amanatides served as Director of Quality Systems for
Celera Genomics, a division of Applied Biosystems involved in genomics and
pharmaceutical discovery. Mr. Amanatides received a B.S. degree in biology
from
Regents College, Albany, New York and a M.S. degree in Biotechnology and
Molecular Biology from Hood College, Frederick, Maryland. Mr. Amanatides has
also held ASQ Certification as a certified Quality Manager.
19
Nola
E. Masterson.
Independent Director since May 2007. Since 1982, she has been the chief
executive officer of Science Futures Inc., an investment and advisory firm.
Ms.
Masterson is currently Managing Member and General Partner of Science Futures
LLC, I, II and III, which are venture capital funds invested in life science
funds and companies. She also serves as a Senior Advisor to TVM Techno Venture
Management, an international venture capital company, and as a member of the
Board of Directors of Repros Therapeutics Inc., a development stage
biopharmaceutical company formerly known as Zonagen, Inc. (currently trading
on
The NASDAQ Global Market under the symbol “RPRX”). Ms. Masterson was the first
biotechnology analyst on Wall Street, working with Drexel Burnham Lambert and
Merrill Lynch, and is a co-founder of Sequenom, Inc., a genetic analysis company
located in San Diego and Hamburg, Germany. She also started the BioTech Meeting
in Laguna Nigel, CA, the annual Biopharmaceutical Conference in Europe, and
was
nominated to the 100 Irish American Business List in 2003. Ms. Masterson began
her career at Ames Company, a division of Bayer, and spent eight years at
Millipore Corporation in sales and sales management. Ms. Masterson has 31 years
of experience in the life science industry. She received her Masters in
Biological Sciences from George Washington University, and continued Ph.D.
work
at the University of Florida.
Two
of
our former directors, Mindy J. Allport-Settle and David E. Wires, elected not
to
stand for re-election to the Board of Directors at the Annual Meeting of
Stockholders held on May 29, 2007. Our Board of Directors nominated Ms.
Masterson for election as director at the 2007 Annual Meeting of the
Stockholders. Our Board now consists of seven directors, four of whom are
independent of Generex management.
Other
Key Employees and Consultants
Slava
Jarnitskii
is our
Financial Controller. He began his employment with Generex Pharmaceuticals
in
September 1996 and has been in the employment of Generex since its acquisition
of Generex Pharmaceuticals in October 1997. Before his employment with Generex
Pharmaceuticals, Mr. Jarnitskii received a Masters of Business Administration
degree from York University in September 1996.
William
D. Abajian
is our
Vice President, Global Business Development. Mr. Abajian has served
in Senior Management and Executive positions throughout the past twenty-five
years where he played pivotal roles in the development and launches of a number
of pharmaceutical and device products. In 1988 he founded CPG Inc.
in Lincoln Park, New Jersey where he served as Chief Executive Officer until
2002. CPG Inc. invented, manufactured and sold DNA Synthesis products,
chromatography media’s and molecular biology kits to researchers in over 40
countries worldwide. This privately-held company was sold to Millipore
Corporation in 2002. Prior to running his own company Mr. Abajian served
as the Vice President of Sales and Marketing at Electro Nucleonics Inc. in
Fairfield, New Jersey between 1981 and 1988. Electro Nucleonics Inc.
invented, manufactured and sold blood chemistry systems and diagnostic kits
worldwide. The company also launched the first FDA approved AIDS
test. At Electro Nucleonics Mr. Abajian was responsible for procuring $50
million of hospital instrumentation sales, opened up the veterinarian market
for
the company and was key to brokering a deal that required all Armed Forces
and
The American Red Cross to purchase all HIV tests from the company. The
organization included five regional managers, 45 sales representatives and
20
technical representatives. In 2004, he founded The Abajian Group LLC, a company
that advises CEOs on strategic planning and assists in the commercialization
of
technologies and sales and marketing. He continues to serve as a trustee
of Eva’s Village, a non-for-profit organization in Paterson, New Jersey, and of
St. Joseph’s Hospital in Paterson, New Jersey, where he previously held the
positions of Chairman of the OPEC Committee and a member of the hospital’s
Finance and Pension Committee and the Executive Committee.
George
Markus
is our
Manager of Regulatory Affairs. Mr. Markus holds a B.Sc. (Honours) in theoretical
chemistry from Dalhousie University and a M.Sc. in analytical chemistry from
McGill University. He is an instructor at the Academy of Applied Pharmaceutical
Sciences in Toronto, Canada. In his more than twenty years in the industry,
he
has been President & Chief Executive Officer of Consolidated Clinical
Research of Canada Inc., a site management organization (SMO) that manages
the
coordination of clinical research sites, and has worked in Quality Assurance
/
Special Projects / Clinical Operations and as a Director, Regulatory Affairs
for
Dimethaid Research Inc. Mr. Markus has also held regulatory affairs positions
with Pasteur Merieux Connaught, Biovail Corporation International, Sanofi
Winthrop, Genpharm Inc. Pharmaceuticals, and Sandoz Canada Inc.
20
Dr.
Jaime Davidson, MD, FACP, FACE
was
appointed a consultant Medical Director for Generex in July, 2006. Dr. Davidson
is the President of Endocrine and Diabetes Associates of Texas, based at the
Medical City Dallas Hospital complex, and a Clinical Associate Professor of
Internal Medicine at University of Texas Southwestern Medical Center in Dallas,
Texas. Dr. Davidson chaired the Diabetes Consensus Guidelines for the American
College of Endocrinology and serves as Director of the Annual Intensive
Diabetes, Endocrinology and Metabolic Diseases Course for the University of
Southern California Keck School of Medicine. He serves as a council member
for
the Texas Department of Health Services, appointed by Texas Governor Rick Perry.
In 2006 Dr. Davidson was distinguished by the American Association of Clinical
Endocrinologists with an award for his contributions to the improvement of
endocrine health for under-served populations, and by the American Diabetes
Association with the Harold Rifkin MD award for his international contributions
in the diabetes field. In the past, he has held positions with the National
Diabetes Advisory Board, the National Institutes of Health, the Centers for
Disease Control, the Institute of Medicine, and the boards of directors of
the
American Diabetes Association, the American Association of Clinical
Endocrinologists, and the American College of Endocrinology. He served in higher
education for a six year term as a Regent of Midwestern State University in
Texas appointed by then Governor George W. Bush. He has also served in the
President's Council for Fitness and Sports, chaired the Texas Diabetes Council
of the Texas Department of Health for several years where he instituted the
Texas Diabetes Algorithm, and under his guidance the Texas Diabetes Institute
was established with the University of Texas Health Science Center in San
Antonio, Texas. Dr. Davidson's experience in clinical pharmacology began with
a
Clinical Pharmacology Fellowship at Lilly Laboratories for Clinical Research
and
it continued with multiple clinical trials. In addition, he was an advisor
to
the Food and Drug Administration (FDA) on the Endocrinology and Metabolism
Advisory Board. Dr. Davidson's Internal Medicine training was completed at
Scott
and White Hospital (now known as Texas A&M University) and his Endocrinology
training at University Of Indiana.
Eric
von Hofe, Ph.D.,
is
currently President of Antigen. He has extensive experience with technology
development projects, including his previous position at Millennium
Pharmaceuticals as Director of Programs & Operations, Discovery Research.
Prior to that, Dr. von Hofe was Director, New Targets at Hybridon, Inc., where
he coordinated in-house and collaborative research that critically validated
gene targets for novel antisense medicines. Dr. von Hofe also held the position
of Assistant Professor of Pharmacology at the University of Massachusetts
Medical School, where he received a National Cancer Institute Career Development
Award for defining mechanisms by which alkylating carcinogens create cancers.
He
received his Ph.D. from the University of Southern California in Experimental
Pathology and was a postdoctoral fellow at both the University of Zurich and
Harvard School of Public Health. His work has been published in twenty-eight
articles in peer-reviewed journals, and he has been an inventor on four patents.
Dr.
Minzhen Xu
is Vice
President - Biology of Antigen. Dr. Xu received an M.D. from Shanghai Medical
University in China and a Ph.D. in immunology from University of Massachusetts
Medical School. He has been with Antigen since its inception and is the
company’s chief experimentalist.
Item
1A. Risk Factors
Our
business and results of operations are subject to numerous risks, uncertainties
and other factors that you should be aware of, some of which are described
below. The risks, uncertainties and other factors described 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.
Any
of the risks, uncertainties and other factors could have a materially adverse
effect on our business, financial condition or results of operations and could
cause the trading price of our common stock to decline substantially.
21
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 fiscal year ended July 31, 2007, we received nominal
revenues from sales of Glucose RapidSpray™. We did not recognize any revenue
from the sale of our oral insulin product in Ecuador in fiscal 2007 and do
not
expect to receive any until we enter into a final agreement with PharmaBrand
to
manufacture commercial orders of Generex Oral-lyn™ and to continue its marketing
and sales efforts in Ecuador in 2008 with a focus towards on the IGT population.
To date, we have not been profitable and our accumulated net loss was
$212,000,270 at July 31, 2007. Our losses have resulted principally from costs
incurred in research and development, including clinical trials, and from
general and administrative costs associated with our operations. While we seek
to attain profitability, we cannot be sure that we will ever achieve product
and
other revenue sufficient for us to attain this objective.
With
the
exception of Generex Oral-lyn™ which is currently available for sale in Ecuador
and our over-the-counter glucose and energy spray products, Glucose RapidSpray™,
BaBOOM!™ Energy Spray and GlucoBreak™, our product candidates are in research or
early stages of pre-clinical and clinical development. We will need to conduct
substantial additional research, development and clinical trials. We will also
need to receive necessary regulatory clearances both in the United States and
foreign countries and obtain meaningful patent protection for and establish
freedom to commercialize each of our product candidates. We must also complete
further clinical trials and seek regulatory approvals for Generex Oral-lyn™ in
countries outside of Ecuador. 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.
We
will need additional capital.
To
progress in product development or marketing, we will need additional capital
which may not be available to us. This may delay our progress in product
development or market.
We
will
require funds in excess of our existing cash resources:
|
·
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to
proceed with the development of our buccal insulin
product;
|
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·
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to
finance the research and development of new products based on our
buccal
delivery and immunomedicine technologies, including clinical testing
relating to new products;
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·
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to
finance the research and development activities of our subsidiary
Antigen
with respect to other potential technologies;
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|
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·
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to
commercially launch and market developed products;
|
|
·
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to
develop or acquire other technologies or other lines of
business;
|
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·
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to
establish and expand our manufacturing capabilities;
|
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·
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to
finance general and administrative activities that are not related
to
specific products under development; and
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·
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to
otherwise carry on business.
|
In
the
past, we have funded most of our development and other costs through equity
financing. We anticipate that our existing capital resources will enable us
to
maintain currently planned operations through the next 12 months. However,
this
expectation is based on our current operating plan, which could change as a
result of many factors, and we may need additional funding sooner than
anticipated. Because our operating and capital resources are insufficient to
meet future requirements, we will have to raise additional funds in the near
future to continue the development and commercialization of our products.
Unforeseen problems, including materially negative developments in our clinical
trials or in general economic conditions, could interfere with our ability
to
raise additional equity capital or materially adversely affect the terms upon
which such funding is available.
22
It
is
possible that we will be unable to obtain additional funding as and when we
need
it. If we were unable to obtain additional funding as and when needed, we could
be forced to delay the progress of certain development efforts. Such a scenario
poses risks. For example, our ability to bring a product to market and obtain
revenues could be delayed, our competitors could develop products ahead of
us,
and/or we could be forced to relinquish rights to technologies, products or
potential products.
Any
new equity financing will dilute current
stockholders.
If
we
raise funds through equity financing to meet the needs discussed above, it
will
have a dilutive effect on existing holders of our shares by reducing their
percentage ownership. The shares may be sold at a time when the market price
is
low because we need the funds. This will dilute existing holders more than
if
our stock price was higher. In addition, equity financings normally involve
shares sold at a discount to the current market price.
Our
research and development and marketing efforts may be highly dependent on
corporate collaborators and other third parties who may not devote sufficient
time, resources and attention to our programs, which may limit our efforts
to
successfully develop and market potential products.
Because
we have limited resources, we have sought to enter into collaboration agreements
with other pharmaceutical companies that will assist us in developing, testing,
obtaining governmental approval for and commercializing products using our
buccal delivery and immunomedicine technologies. Any collaborator with whom
we
may enter into such collaboration agreements may not support fully our research
and commercial interests since our program may compete for time, attention
and
resources with such collaborator's internal programs. Therefore, these
collaborators may not commit sufficient resources to our program to move it
forward effectively, or that the program will advance as rapidly as it might
if
we had retained complete control of all research, development, regulatory and
commercialization decisions.
Risks
Related to Our Technologies
With
the exception of Generex Oral-lyn™, Glucose RapidSpray™, BaBOOM! ™ Energy Spray
and GlucoBreak™, our technologies and products are at an early stage of
development and we cannot expect revenues in respect thereof in the foreseeable
future.
We
have
no products approved for commercial sale at the present time with the exception
of Generex Oral-lyn™ which is available only in Ecuador and our glucose sprays
which are available over-the-counter in retail outlets in the United States
and
Canada. To be profitable, we must not only successfully research, develop and
obtain regulatory approval for our products under development, but also
manufacture, introduce, market and distribute them once development is
completed. We may not be successful in one or more of these stages of the
development or commercialization of our products, and/or any of the products
we
develop may not be commercially viable.
Although
Generex Oral-lyn™, our proprietary oral insulin spray formulation, has been
approved for commercial marketing and sale in Ecuador, and our glucose spray
products are available for purchase in the United States and Canada, we have
yet
to manufacture, market and distribute these products on a large-scale commercial
basis. We expect to receive nominal revenues from sales of these products in
fiscal year 2008. Until we can establish that they are commercially viable
products, we will not receive significant revenues from ongoing operations.
23
Until
we receive regulatory approval to sell
our pharmaceutical products in additional countries, our ability to generate
revenues from operations may be limited and those revenues may be insufficient
to sustain operations. Many factors impact our ability to obtain approvals
for
commercially viable products.
Our
only
pharmaceutical product that has been approved for commercial sale by drug
regulatory authorities is our oral insulin spray formulation, and that approval
was obtained in Ecuador. We have begun the regulatory approval process for
our
oral insulin, buccal morphine and fentanyl products in other countries, and
we
expect to begin late stage clinical trials of Generex Oral-lyn™ at some of our
clinical trial sites according to the Phase III clinical plan before the end
of
calendar year 2007.
Our
immunomedicine products are in the pre-clinical stage of development, with
the
exception of a Phase II trial in human patients with stage II HER-2/neu positive
breast cancer, a Phase I trial in human volunteers of a peptide vaccine for
use
against the H5N1 avian influenza virus and Phase I trial of our experimental
H5N1 prophylactic vaccine in Beirut, Lebanon.
Pre-clinical
and clinical trials of our products, and the manufacturing and marketing of
our
technologies, are subject to extensive, costly and rigorous regulation by
governmental authorities in the United States, Canada and other countries.
The
process of obtaining required regulatory approvals from the FDA and other
regulatory authorities often takes many years, is expensive and can vary
significantly based on the type, complexity and novelty of the product
candidates. For these reasons, it is possible we will not receive regulatory
approval for any prescription pharmaceutical product candidate in any country
other than Ecuador.
In
addition, we cannot be sure when or if we will be permitted by regulatory
agencies to undertake additional clinical trials or to commence any particular
phase of clinical trials. Because of this, statements in this Annual Report
regarding the expected timing of clinical trials cannot be regarded as actual
predictions of when we will obtain regulatory approval for any "phase" of
clinical trials.
Delays
in
obtaining United States or other foreign approvals for our pharmaceutical
products could result in substantial additional costs to us, and, therefore,
could adversely affect our ability to compete with other companies. If
regulatory approval is ultimately granted in any country other than Ecuador,
the
approval may place limitations on the intended use of the product we wish to
commercialize, and may restrict the way in which we are permitted to market
the
product.
Due
to legal and factual uncertainties regarding the scope and protection afforded
by patents and other proprietary rights, we may not have meaningful protection
from competition.
Our
long-term success will substantially depend upon our ability to protect our
proprietary technologies from infringement, misappropriation, discovery and
duplication and avoid infringing the proprietary rights of others. Our patent
rights, and the patent rights of biotechnology and pharmaceutical companies
in
general, are highly uncertain and include complex legal and factual issues.
Because of this, our pending patent applications may not be granted. These
uncertainties also mean that any patents that we own or will obtain in the
future could be subject to challenge, and even if not challenged, may not
provide us with meaningful protection from competition. Due to our financial
uncertainties, we may not possess the financial resources necessary to enforce
our patents. Patents already issued to us or our pending applications may become
subject to dispute, and any dispute could be resolved against us.
Because
a
substantial number of patents have been issued in the field of alternative
drug
delivery and because patent positions can be highly uncertain and frequently
involve complex legal and factual questions, the breadth of claims obtained
in
any application or the enforceability of our patents cannot be predicted.
Consequently, we do not know whether any of our pending or future patent
applications will result in the issuance of patents or, to the extent patents
have been issued or will be issued, whether these patents will be subject to
further proceedings limiting their scope, will provide significant proprietary
protection or competitive advantage, or will be circumvented or invalidated.
Also
because of these legal and factual uncertainties, and because pending patent
applications are held in secrecy for varying periods in the United States and
other countries, even after reasonable investigation we may not know with
certainty whether any products that we (or a licensee) may develop will infringe
upon any patent or other intellectual property right of a third party. For
example, we are aware of certain patents owned by third parties that such
parties could attempt to use in the future in efforts to affect our freedom
to
practice some of the patents that we own or have applied for. Based upon the
science and scope of these third-party patents, we believe that the patents
that
we own or have applied for do not infringe any such third-party patents;
however, we cannot know for certain whether we could successfully defend our
position, if challenged. We may incur substantial costs if we are required
to
defend our intellectual property in patent suits brought by third parties.
These
legal actions could seek damages and seek to enjoin testing, manufacturing
and
marketing of the accused product or process. In addition to potential liability
for significant damages, we could be required to obtain a license to continue
to
manufacture or market the accused product or process.
24
Risks
Related to Marketing of Our Potential Products
We
may not become, or stay, profitable even if our pharmaceutical products are
approved for sale.
Even
if
we obtain regulatory approval to market our oral insulin product or any other
prescription pharmaceutical product candidate in another country other than
Ecuador, many factors may prevent the product from ever being sold in commercial
quantities. Some of these factors are beyond our control, such as:
|
·
|
acceptance
of the formulation or treatment by health care professionals and
diabetic
patients;
|
|
·
|
the
availability, effectiveness and relative cost of alternative diabetes
or
immunomedicine treatments that may be developed by competitors;
and
|
|
·
|
the
availability of third-party (i.e., insurer and governmental agency)
reimbursements.
|
We
will
not receive significant revenues from Generex Oral-lyn™ in Ecuador or in the
United States or from any of our other pharmaceuticals products that may receive
regulatory approval until we can successfully manufacture, market and distribute
them in the relevant market.
Similarly,
the successful commercialization of our over-the-counter glucose spray products
may be hindered by manufacturing, marketing and distribution
limitations.
We
have
to depend upon others for marketing and distribution of our products, and we
may
be forced to enter into contracts limiting the benefits we may receive and
the
control we have over our products. We intend to rely on collaborative
arrangements with one or more other companies that possess strong marketing
and
distribution resources to perform these functions for us. We may not be able
to
enter into beneficial contracts, and we may be forced to enter into contracts
for the marketing and distribution of our products that substantially limit
the
potential benefits to us from commercializing these products. In addition,
we
will not have the same control over marketing and distribution that we would
have if we conducted these functions ourselves.
We
may not be able to compete with treatments now being marketed and developed,
or
which may be developed and marketed in the future by other
companies.
Our
products will compete with existing and new therapies and treatments. We are
aware of a number of companies currently seeking to develop alternative means
of
delivering insulin, as well as new drugs intended to replace insulin therapy
at
least in part. We are also aware of a number of companies currently seeking
to
develop alternative means of enhancing and suppressing peptides. In the longer
term, we also face competition from companies that seek to develop cures for
diabetes and other malignant, infectious, autoimmune and allergic diseases
through techniques for correcting the genetic deficiencies that underlie such
diseases.
Numerous
pharmaceutical, biotechnology and drug delivery companies, hospitals, research
organizations, individual scientists and nonprofit organizations are engaged
in
the development of alternatives to our technologies. Some of these companies
have greater research and development capabilities, experience, manufacturing,
marketing, financial and managerial resources than we do. Collaborations or
mergers between large pharmaceutical or biotechnology companies with competing
drug delivery technologies could enhance our competitors’ financial, marketing
and other resources. Developments by other drug delivery companies could make
our products or technologies uncompetitive or obsolete. Accordingly, our
competitors may succeed in developing competing technologies, obtaining FDA
approval for products or gaining market acceptance more rapidly than we can.
25
A
direct
competitor to Generex Oral-lyn™ is Exubera®, Pfizer, Inc.’s inhalable form of
insulin. Exubera®, which is inhaled through the mouth and absorbed in the lungs,
is the first non-injected insulin to be approved by the FDA. Since May 2006,
Pfizer has launched Exubera® has in Germany, Ireland, the U.K. and in the U.S.
Initial supplies of Exubera were available across the U.S. beginning in
September 2006, but Exubera® has had slow acceptance by patients and physicians
and underperformed according to sector analysts. Pfizer has had to increase
training of its sales force and diabetes educators to assist physicians and
patients in understanding the benefits of and in using Exubera®. Pfizer began
branded direct-to-consumer advertising of Exubera® in print ads in mid-June 2007
and television ads in July 2007. While we believe that absorption though the
buccal cavity offers several advantages over pulmonary absorption, Pfizer’s
early approval and significant resources could allow it to capture a large
portion of the market.
Pfizer
and Nektar are currently collaborating on the development of a next generation
inhaled insulin device, which would have improved portability, convenience,
reliability and ease of use over Exubera®. In addition to Pfizer and Nektar, we
have other direct competitors with development programs underway for inhaled
insulin products, which, if approved, could compete against Generex Oral-lyn™.
These companies include Novo Nordisk, Eli Lilly Company /Alkermes, Inc, MannKind
Corporation, Bentley Pharmaceuticals, Inc. and Abbott Laboratories through
its
acquisition of Kos Pharmaceuticals, all of which are working on various versions
of inhaled insulin products in either a liquid or a dry form. Some products
are
in late stage clinical testing including Alkermes’s inhalable insulin product
(AIR Insulin System™) in Phase III clinical development and Mannkind’s
Technosphere® Insulin System also in Phase III clinical development. Other
smaller companies, including Emisphere Technologies, Inc., are in various stages
of developing oral or buccal insulin formulations.
If
government programs and insurance companies do not agree to pay for or reimburse
patients for our pharmaceutical products, our success will be
impacted.
Sales
of
our oral insulin formulation in Ecuador and our other potential pharmaceutical
products in other markets depend in part on the availability of reimbursement
by
third-party payers such as government health administration authorities, private
health insurers and other organizations. Third-party payers often challenge
the
price and cost-effectiveness of medical products and services. Governmental
approval of health care products does not guarantee that these third-party
payers will pay for the products. Even if third-party payers do accept our
product, the amounts they pay may not be adequate to enable us to realize a
profit. Legislation and regulations affecting the pricing of pharmaceuticals
may
change before our products are approved for marketing and any such changes
could
further limit reimbursement.
Risks
Related to Potential Liabilities
We
face significant product liability risks, which may have a negative effect
on
our financial condition.
The
administration of drugs or treatments to humans, whether in clinical trials
or
commercially, can result in product liability claims whether or not the drugs
or
treatments are actually at fault for causing an injury. Furthermore, our
pharmaceutical products may cause, or may appear to have caused, serious adverse
side effects (including death) or potentially dangerous drug interactions that
we may not learn about or understand fully until the drug or treatment has
been
administered to patients for some time. Product liability claims can be
expensive to defend and may result in large judgments or settlements against
us,
which could have a severe negative effect on our financial condition. We
maintain product liability insurance in amounts we believe to be commercially
reasonable for our current level of activity and exposure, but claims could
exceed our coverage limits. Furthermore, due to factors in the insurance market
generally and our own experience, we may not always be able to purchase
sufficient insurance at an affordable price. Even if a product liability claim
is not successful, the adverse publicity and time and expense of defending
such
a claim may interfere with our business.
26
Risks
Related to the Market for Our Common Stock
Our
common stock could be delisted from The NASDAQ Capital
Market.
In
the
past, we have failed to comply with certain of NASDAQ’s listing requirements. In
late 2004, we did not comply with NASDAQ Rule 4310(c)(2)(B) which requires
us to
have a minimum of $2,500,000 in stockholders' equity or $35,000,000 market
value
of listed securities or $500,000 of net income from continuing operations for
the most recently completed fiscal year or two of the three most recently
completed fiscal years. While we regained compliance with this standard, we
are
still in the development stage. Consequently, there is no guarantee that we
will
sustain compliance with this standard. In the event we cannot sustain
compliance, our shares of common stock may be delisted from the NASDAQ Capital
Market and begin trading on the over-the-counter bulletin board, assuming we
meet the requisite criteria.
In
addition, from October 2004 until October 2005, we failed to comply with NASDAQ
Rule 4310(c)(4) which requires us to have a minimum bid price per share of
at
least $1.00. Although we regained compliance with the minimum bid price
requirement in November 2005, there is no guarantee that the bid price of our
common stock will remain at or above $1.00 per share. In the event that the
price of our common stock falls below $1.00 per share for thirty (30)
consecutive trading days, we would likely receive a notice from the NASDAQ
Stock
Market LLC informing us of our noncompliance with NASDAQ Rule 4310(c)(4) and
giving us 180 calendar days, subject to extension, to regain compliance with
the
rule. In the event that we could not demonstrate compliance with NASDAQ Rule
4310(c)(4) by the specified deadline and were not eligible for an additional
compliance period, the staff would notify us that our stock would be delisted,
at which time we could appeal the staff’s determination to a Listing
Qualifications Panel. Pending the decision of the Listing Qualification Panel,
our common stock would continue to trade on the NASDAQ Capital Market. If we
were not successful in such an appeal, our stock would likely trade on NASDAQ’s
over-the-counter bulletin board, assuming we meet the requisite
criteria.
If
we fail to maintain compliance with applicable NASDAQ Rules and our stock is
delisted from the NASDAQ Capital Market, it may become subject to Penny Stock
Regulations and there will be less interest for our stock in the market. This
may result in lower prices for our stock and make it more difficult for us
to
obtain financing.
If
our
stock is not listed on NASDAQ and fails to maintain a price of $5.00 or more
per
share, our stock would become subject to the Securities and Exchange
Commission's "Penny Stock" rules. These rules require a broker to deliver,
prior
to any transaction involving a Penny Stock, a disclosure schedule explaining
the
Penny Stock Market and its risks. Additionally, broker/dealers who recommend
Penny Stocks to persons other than established customers and accredited
investors must make a special written suitability determination and receive
the
purchaser's written agreement to a transaction prior to the sale. In the event
our stock becomes subject to these rules, it will become more difficult for
broker/dealers to sell our common stock. Therefore, it may be more difficult
for
us to obtain financing.
The
price of our common stock may be volatile.
There
may
be wide fluctuations in the price of our common stock. These fluctuations may
be
caused by several factors including:
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·
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announcements
of research activities and technology innovations or new products
by us or
our competitors;
|
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·
|
changes
in market valuation of companies in our industry
generally;
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·
|
variations
in operating results;
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·
|
changes
in governmental regulations;
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27
|
·
|
Developments
in patent and other proprietary
rights;
|
|
·
|
public
concern as to the safety of drugs or treatments developed by us or
others;
|
|
·
|
results
of clinical trials of our products or our competitors' products;
and
|
|
·
|
regulatory
action or inaction on our products or our competitors'
products.
|
From
time
to time, we may hire companies to assist us in pursuing investor relations
strategies to generate increased volumes of investment in our common stock.
Such
activities may result, among other things, in causing the price of our common
stock to increase on a short-term basis.
Furthermore,
the stock market generally and the market for stocks of companies with lower
market capitalizations and small biopharmaceutical companies, like us, have
from
time to time experienced, and likely will again experience significant price
and
volume fluctuations that are unrelated to the operating performance of a
particular company.
Provisions
of our Restated Certificate of Incorporation could delay or prevent the
acquisition or sale of our business.
Our
Restated Certificate of Incorporation permits our Board of Directors to
designate new series of preferred stock and issue those shares without any
vote
or action by our stockholders. Such newly authorized and issued shares of
preferred stock could contain terms that grant special voting rights to the
holders of such shares that make it more difficult to obtain stockholder
approval for an acquisition of our business or increase the cost of any such
acquisition.
Item1B. Unresolved
Staff Comments.
None.
Item
2. Properties.
Our
executive and principal administrative offices occupy approximately 5,000 square
feet of office space in the Business Centre at 33 Harbour Square in downtown
Toronto, Ontario, Canada. We own the Business Centre, which comprises
approximately 9,100 square feet of usable space. The space in the Business
Centre that is not used by us is leased to third parties.
We
own a
laboratory facility in Toronto that we have used for limited production of
our
oral insulin formulation for clinical purposes, and have completed a pilot
manufacturing facility for our insulin and glucose products in the same
commercial complex. Our laboratory facility is approximately 2,650 square feet.
Our pilot manufacturing facility, which also includes laboratory facilities,
is
approximately 4,800 square feet. We also own all additional units in the same
building where our pilot manufacturing facility is located. These units are
currently leased to third parties with the exception of two units being used
by
us for packaging and storage. These units are reflected in Assets Held for
Investments on accompanying consolidated balance sheets. All of these spaces
could be used for manufacturing facilities if necessary. We have obtained
regulatory approval for the laboratory facility and the pilot manufacturing
facility.
We
have
mortgages on our Toronto properties totaling $3,143,789 at July 31, 2007. These
mortgages require the payment of interest, with minimal principal reduction,
prior to their due dates. These mortgages currently require an aggregate
approximately $25,800 in monthly debt service payments. Aggregate principal
maturities for these mortgages will be $84,503 in fiscal 2008 and $3,059,286
in
fiscal 2009 and thereafter.
28
We
lease
approximately 4,336 square feet of office and laboratory space in Worcester,
Massachusetts that Antigen uses for its research and development activities
at
an annual rent of approximately $156,000. This space is sufficient for Antigen’s
present activities.
We
do not
expect to need additional manufacturing capabilities in Canada related to our
insulin product beyond our pilot facility before the end of the current fiscal
year. We own an 11,625 square foot building in Brampton, Ontario, which is
approximately 25 miles outside Toronto, and a 13,500 square foot building in
Mississauga, Ontario, which is about 20 miles from downtown Toronto. Both
properties are currently leased to third parties. These properties are reflected
in Assets Held for Investments on accompanying consolidated balance
sheets.
We
could
use our other properties to expand research, development or testing of our
buccal and immunomedicine products if current facilities prove inadequate for
our needs. We also may consider other opportunities to expand our manufacturing
capabilities as such opportunities arise.
Item
3. Legal
Proceedings.
Subash
Chandarana et al. v. Generex Biotechnology Corporation.
In
February 2001, a former business associate of Dr. Pankaj Modi ("Modi") (our
former officer) and an entity called Centrum Technologies Inc. ("CTI") commenced
an action in the Ontario Superior Court of Justice against us and Modi seeking,
among other things, damages for alleged breaches of contract and tortious acts
related to a business relationship between this former associate and Modi that
ceased in July 1996. The plaintiffs’ statement of claim also seeks to enjoin the
use, if any, by us of three patents allegedly owned by CTI. On July 20, 2001,
we
filed a preliminary motion to dismiss the action of CTI as a nonexistent entity
or, alternatively, to stay such action on the grounds of want of authority
of
such entity to commence the action. The plaintiffs brought a cross motion to
amend the statement of claim to substitute Centrum Biotechnologies, Inc. ("CBI")
for CTI. CBI is a corporation of which 50 percent of the shares are owned by
the
former business associate and the remaining 50 percent are owned by us.
Consequently, the shareholders of CBI are in a deadlock. The court granted
our
motion to dismiss the action of CTI and denied the plaintiffs’ cross motion
without prejudice to the former business associate to seek leave to bring a
derivative action in the name of or on behalf of CBI. The former business
associate subsequently filed an application with the Ontario Superior Court
of
Justice for an order granting him leave to file an action in the name of and
on
behalf of CBI against Modi and us. We opposed the application. In September
2003, the Ontario Superior Court of Justice granted the request and issued
an
order giving the former business associate leave to file an action in the name
of and on behalf of CBI against Modi and us. A statement of claim was served
in
July 2004. We are not able to predict the ultimate outcome of this legal
proceeding at the present time or to estimate an amount or range of potential
loss, if any, from this legal proceeding.
Michael
Powell.
In
August, 2006, Michael Powell commenced an action against certain defendants,
including us and certain of our officers, in the Ontario Superior Court of
Justice, claiming compensatory damages, special and punitive damages and various
forms of injunctive and declaratory relief for breach of contract and various
business torts. We believe the claims against us are frivolous and completely
without merit. We are not a party to any agreement with the plaintiff. Much
of
the requested relief relates to the plaintiff’s position and ownership interest
in and accounting for the expenses of an entity in which Generex has no
interest. We have not used any intellectual property or information owned by
the
other entity. All intellectual property, information and business claimed to
be
owned or conducted by the entity in which the plaintiff claims an interest
are
completely unrelated to any product or technology we are currently developing
or
intend to develop. Therefore, even if the court were to award some declaratory
or injunctive relief, we would not be affected. We are defending this action
vigorously. We have brought a motion seeking to have the action dismissed as
against Generex which motion is presently scheduled for hearing on October
17,
2007. We are not able to predict the ultimate outcome of this legal proceeding
at the present time or to estimate an amount or range of potential loss, if
any,
from this legal proceeding.
Shemano
Group, Inc.
On
September 26, 2006, Shemano Group, Inc. initiated a National Association of
Securities Dealers arbitration proceeding against us. Shemano claimed it was
entitled to be paid fees pursuant to a finder’s agreement in connection with
certain private placements effected by us The arbitration hearing took place
in
June 2007 and in July 2007 the arbitration panel awarded Shemano an aggregate
of
$1,030,545 in cash in compensatory damages. A third party subsequently initiated
an arbitration proceeding claiming an entitlement to 60% of the award.
Consequently, we paid 40% of the award to Shemano in September 2007. We are
currently seeking a ruling from the court to deposit the remaining portion
of
the award ($618,327) with the court in respect of the new arbitration
proceeding.
29
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
4. Submission
of Matters to a Vote of Security Holders.
Our
Annual Meeting of Stockholders was held on May 29, 2007. At the meeting,
85,778,779 shares of common stock were represented out of 108,247,742 shares
that were entitled to vote. Our stockholders took the following actions at
the
Annual Meeting:
|
·
|
elected
all seven nominees to the Board of Directors;
and
|
|
·
|
ratified
the appointment of Danziger & Hochman Partners LLP as our independent
public accountants for the fiscal year ending July 31,
2007.
|
The
results of the vote for the Board of Directors was as follows:
Election
of nominees to Board of Directors
for
terms expiring May 30, 2008
|
|
Votes
For
|
|
Votes
Against
|
|
Abstentions
|
ANNA
E. GLUSKIN
|
98.954%
|
0.000%
|
1.040%
|
|||
84,881,128
|
5,200
|
892,450
|
||||
JOHN
P. BARRATT
|
99.298%
|
0.000%
|
0.696%
|
|||
85,176,582
|
5,200
|
596,996
|
||||
BRIAN
T. MCGEE
|
99.282%
|
0.000%
|
0.712%
|
|||
85,163,212
|
5,200
|
610,366
|
||||
NOLA
E. MASTERSON
|
99.260%
|
0.000%
|
0.734%
|
|||
85,143,865
|
5,200
|
629,713
|
||||
GERALD
BERNSTEIN, M.D.
|
99.255%
|
0.000%
|
0.739%
|
|||
85,139,771
|
5,200
|
633,807
|
||||
PETER
G. AMANATIDES
|
99.198%
|
0.000%
|
0.796%
|
|||
85,090,647
|
5,200
|
682,931
|
||||
ROSE
C. PERRI
|
99.127%
|
0.000%
|
0.867%
|
|||
85,029,766
|
5,200
|
743,812
|
The
results on the votes of the proposals were as follows:
Proposal
|
|
Votes
For
|
|
Votes
Against
|
|
Abstention
|
|
Broker
Non-Votes
|
Ratification
of Danziger & Hochman, Chartered Accountants
|
|
99.400%
85,264348
|
0.208%
178,304
|
0.3392%
336,126
|
0
|
30
PART
II
Item
5. Market
For Registrant’s Common Equity, Related Stockholder Matters and
Issuer Purchases of Equity
Securities.
|
Market
Information
Our
common stock has been listed on the NASDAQ Capital Market (formerly the NASDAQ
SmallCap Market) since June 5, 2003. From May 5, 2000 to June 4, 2003, our
common stock was listed on the NASDAQ National Market. From February 1998 to
May
2000, the "bid" and "asked" prices for our common stock were quoted on the
OTC
Bulletin Board operated by the National Association of Securities Dealers.
Prior
to February 1998, there was no public market for our common stock.
The
table
below also sets forth the high and low sales prices for our common stock
reported on the NASDAQ Capital Market for each fiscal quarter in the prior
two
years ended July 31, 2007.
|
Bid
Prices
|
||||||
|
High
|
Low
|
|||||
Fiscal
2006
|
|
|
|||||
First
Quarter
|
$
|
1.51
|
$
|
0.53
|
|||
Second
Quarter
|
$
|
1.48
|
$
|
0.8
|
|||
Third
Quarter
|
$
|
5.02
|
$
|
1.15
|
|||
Fourth
Quarter
|
$
|
3.25
|
$
|
1.3
|
|||
Fiscal
2007
|
|||||||
First
Quarter
|
$
|
2.70
|
1.25
|
||||
Second
Quarter
|
$
|
2.32
|
1.53
|
||||
Third
Quarter
|
$
|
1.97
|
1.60
|
||||
Fourth
Quarter
|
$
|
2.14
|
1.26
|
The
sales
for our common stock reported on October 03, 2007 was $1.48.
As
of
October 3, 2007, there were approximately 727 holders of record of our common
stock. Record holders do not include owners whose shares are held in street
name
by a broker or other nominee.
Dividends
We
have
not paid dividends on our common stock in the past and have no present intention
of paying dividends in the foreseeable future.
Stock
Performance Graph
The
following information under this heading “Stock Performance Graph” in
this
Part II, Item 5
of this
Annual Report on Form 10-K is not deemed to be “soliciting material” or to be
“filed” with the SEC or subject to Regulation 14A or 14C under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or to the liabilities of
Section 18 of the Exchange Act, and will not be deemed to be incorporated by
reference into any filing under the Securities Act of 1933, as amended (the
“Securities Act”), or the Exchange Act, except to the extent we specifically
incorporate it by reference into such a filing.
31
Set
forth
below is a line graph comparing the cumulative total return on Generex's common
stock with cumulative total returns of the NASDAQ Stock Market (U.S. Companies)
and the NASDAQ Biotechnology Index for the period commencing July 31, 2002
and
ending on July 31, 2007. The graph assumes that $100 was invested on July 31,
2002, in Generex's common stock, the stocks in the NASDAQ Stock Market (U.S.
Companies) and the stocks comprising the NASDAQ Biotechnology Index, and that
all dividends were reinvested. Generex's common stock began trading on the
NASDAQ SmallCap Market (now known as the NASDAQ Capital Market) on June 5,
2003.
Sales
of Unregistered Securities
In
the
fiscal year ended July 31, 2007, we sold common stock and other securities
in
transactions in reliance upon exemptions from the registration requirements
of
the Securities Act, as we have reported on Current Reports on Quarterly Reports
on Form 10-Q filed during the period covered by this Annual Report on Form
10-K.
32
As
previously reported in our Annual Report on Form 10-K for the fiscal year ended
July 31, 2006 and our Quarterly Reports for the quarters ended October 31,
2006,
January 31, 2007 and April 30, 2007, we have issued shares of our common stock
to CEOcast, Inc., a consultant, pursuant to an agreement to provide us with
investor relation services until August 21, 2007. During the three months ended
July 31, 2007, we issued 75,000 shares of common stock to CEOcast pursuant
to
this agreement. The sale of such shares was exempt from registration under
the
Securities Act in reliance upon Section 4(2) thereof. We believe that CEOcast,
Inc. is an “accredited investor” as that term is defined in Rule 501(a) of
Regulation D under the Securities Act. The certificates issued for the shares
of
common stock will be legended to indicate that they are restricted. The sales
of
such securities did not involve the use of underwriters, and no commissions
were
paid in connection therewith.
During
the twelve months ended July 31, 2007, we issued 118,185 shares of common stock
to American Capital Ventures, Inc. pursuant to an agreement with us for
financial services. The sale of such shares was exempt from registration under
the Securities Act in reliance upon Section 4(2) thereof. We believe that
American Capital Ventures, Inc. is an “accredited investor” as that term is
defined in Rule 501(a) of Regulation D under the Securities Act. The
certificates issued for the shares of common stock will be legended to indicate
that they are restricted. The sales of such securities did not involve the
use
of underwriters, and no commissions were paid in connection therewith.
During
the twelve months ended July 31, 2007, we issued 140,912 shares of common stock
to Lyons Capital LLC. pursuant to an agreement with us for financial services.
The sale of such shares was exempt from registration under the Securities Act
in
reliance upon Section 4(2) thereof. We believe that Lyons Capital LLC. is an
“accredited investor” as that term is defined in Rule 501(a) of Regulation D
under the Securities Act. The certificates issued for the shares of common
stock
will be legended to indicate that they are restricted. The sales of such
securities did not involve the use of underwriters, and no commissions were
paid
in connection therewith.
In
May,
2007, we issued 450,000 shares of common stock to Sound Capital Inc. for
financial services. The sale of such shares was exempt from registration under
the Securities Act in reliance upon Section 4(2) thereof. We believe that Sound
Capital, Inc. is an “accredited investor” as that term is defined in Rule 501(a)
of Regulation D under the Securities Act. The certificates issued for the shares
of common stock will be legended to indicate that they are restricted. The
sales
of such securities did not involve the use of underwriters, and no commissions
were paid in connection therewith.
Issuer
Purchases of Equity Securities
Neither
we nor any affiliated purchaser (as defined in Section 240.10 b-18(a)(3) of
the
Exchange Act) purchased any of our equity securities during the fourth quarter
of the fiscal year ending July 31, 2007.
Item
6. Selected
Financial Data.
The
following selected financial data are derived from and should be read in
conjunction with our financial statements and related notes, which appear
elsewhere in this Annual Report on Form 10-K. Our financial statements for
the
year end July 31, 2007 and 2006 were audited by Danziger Hochman Partners LLP
(formerly known as Danziger & Hochman, Chartered Accountants). Our financial
statements for the years ended July 31, 2005, 2004 and 2003 were audited by
BDO
Dunwoody, LLP.
In
thousands
|
2007
|
2006
|
2005
|
2004
|
2003
|
|||||||||||
Operating
Results:
|
||||||||||||||||
Revenue
|
$
|
180
|
$
|
175
|
$
|
392
|
$
|
627
|
$
|
—
|
||||||
Net
Loss
|
(23,505
|
)
|
(67,967
|
)
|
(24,002
|
)
|
(18,363
|
)
|
(13,262
|
)
|
||||||
Net
Loss Available to Common Stockholders
|
(23,505
|
)
|
(67,967
|
)
|
(24,002
|
)
|
(19,173
|
)
|
(14,026
|
)
|
||||||
Cash
Dividends per share
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Loss
per Common Share:
|
||||||||||||||||
Basic
and Diluted Net Loss Per Common Share
|
(.22
|
)
|
(.90
|
)
|
(.66
|
)
|
(.64
|
)
|
(.67
|
)
|
||||||
Financial
Positions:
|
||||||||||||||||
Total
Assets
|
$
|
46,404
|
$
|
64,105
|
$
|
13,466
|
$
|
19,012
|
$
|
22,639
|
||||||
Long-Term
Debt
|
$
|
3,144
|
$
|
3,036
|
$
|
3,288
|
$
|
2,225
|
$
|
1,895
|
||||||
Convertible
Debentures
|
$
|
—
|
$
|
161
|
$
|
1,315
|
$
|
—
|
$
|
—
|
||||||
Series
A, Preferred Stock
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
14,310
|
$
|
13,501
|
||||||
Stockholder's
Equity
|
$
|
36,071
|
$
|
55,464
|
$
|
6,127
|
$
|
530
|
$
|
5,857
|
33
Item
7. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
The
following discussion and analysis by management provides information with
respect to our financial condition and results of operations for the fiscal
years ended July 31, 2005, 2006 and 2007. This discussion should be read in
conjunction with the information in the consolidated financial statements and
the notes pertaining thereto contained in Item
8 - Financial Statements and Supplementary Data
of this
Annual Report on Form 10-K for the year ended July 31, 2007 and the information
discussed in Part
I, Item 1A - Risk Factors.
Executive
Summary
About
the Company
We
are
engaged primarily in the research, development, and commercialization of drug
delivery systems and technologies. Our primary focus at the present time is
our
proprietary technology for the administration of formulations of large molecule
drugs to the oral (buccal) cavity using a hand-held aerosol applicator. Through
our wholly-owned subsidiary, Antigen, we are expanding our focus to include
immunomedicines. We operate in only one segment: the research, development
and
commercialization of drug delivery systems and technologies for metabolic and
immunological diseases.
We
have a
limited number of products that are ready for commercial marketing and sale:
our
oral insulin formulation, Generex Oral-lyn™, has been approved for commercial
marketing and sale in Ecuador; and our over-the-counter line glucose spray
products utilizing our proprietary RapidMist™ buccal delivery technology have
been launched in retail outlets in the United States and Canada.
We
have
begun the regulatory approval process for six pharmaceutical products: our
oral
insulin formulation (late-stage), our oral morphine formulation (pre-clinical),
the Antigen HER-2/neu positive breast cancer vaccine (Phase II), the Antigen
avian influenza vaccine (Phase I), the Antigen prostate cancer vaccine (Phase
I), and the Antigen RNAi immunotherapeutic technology for myelogenous leukemia
(pre-clinical).
Our
organizational structure consists of Generex Biotechnology Corporation and
five
wholly-owned subsidiaries: Generex Pharmaceuticals Inc., which is incorporated
in Ontario, Canada and which performs all of our Canadian operations; Generex
(Bermuda), Inc., which is incorporated in Bermuda and which currently does
not
conduct any business activities; Antigen Express, Inc., which is incorporated
in
Delaware and which we acquired in 2003; Generex Pharmaceuticals (USA) LLC,
which
we organized in North Carolina in February 2006 and which has not yet commenced
any business operations; and Generex Marketing & Distribution Inc., which we
organized in Ontario, Canada in September 2006 and which has not yet commenced
any business operations.
We
are a
development stage company. From inception through the end of the 2007 fiscal
year, we have received only limited revenues from operations. Pursuant to a
development and license agreement that we entered into with Eli Lilly and
Company in September 2000 and terminated as of June 2003, we received a
$1,000,000 upfront payment. In fiscal 2007, we received approximately $136,448
in revenues from sales of Glucose RapidSpray™.
34
Strategy
With
the
launch of commercial sales of our over-the-counter oral glucose and energy
spray
products in retail outlets in the United States and Canada, we expect to receive
increased revenues from product sales in the fiscal year ending July 31, 2008.
We plan to achieve this by increasing our over-the-counter product line to
three
products and expanding our existing distribution channels. In addition, we
will
increase our advertising and marketing efforts of our products and expand the
availability of our products from North America to the rest of the world. This
strategy has already been effected by the execution of agreements with Leosons
General Trading Company for all products and Adcock Ingram LLP and Adcock Ingram
Healthcare (Pty) Ltd. for Glucose RapidSpray ™.
We
also
expect to derive some revenue from product sales of our oral insulin formulation
Generex Oral-lyn™. We project that revenues generated from sales of both our
glucose and energy spray products in the U.S. and Canada and sales of Generex
Oral-lyn™ in Ecuador will not be sufficient for all of our cash needs during
fiscal year 2008. In the past we were able to fund Antigen expenses with some
revenue from research grants for Antigen's immunomedicine products. During
the
fiscal year ended July 31, 2007, 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 the fiscal years ending
July 31, 2005 and 2006, we believe that we have secured the funds necessary
to
continue in the short term with the commercialization of Generex Oral-lyn™ in
Ecuador, to seek regulatory approval for this product in certain other countries
and to pursue late-stage clinical trials of this product in the United States,
Canada and Europe. We also project that we will have the funds to support
further research and development and limited clinical testing of technology
created by Antigen.
We
will
continue to require substantial funds to continue research and development,
including preclinical studies and clinical trials of our product candidates,
and
to commence sales and marketing efforts if the Food and Drug Administration
or
other regulatory approvals are obtained. Management may seek to meet all or
some
of our operating cash flow requirements through financing activities, such
as
private placement of our common stock, preferred stock offerings and offerings
of debt and convertible debt instruments. We have filed a shelf registration
statement with the Securities and Exchange Commission (“SEC”) to register an
indeterminate number of shares of common stock and preferred stock and an
indeterminate number of warrants and units, the aggregate initial offering
price
of which is not to exceed $150,000,000. Management is actively pursuing industry
collaboration activities, including product licensing and specific project
financing.
In
fiscal
2008, we plan to concentrate our activities on enrollment and dosing of
late-stage clinical trials of Generex Oral-lynTM
in the
United States, Canada and Europe. In anticipation of undertaking late-stage
clinical trials globally, we have engaged consultants to assist with the design
and implementation of clinical trials and regulatory strategies. We also have
secured a manufacturer to produce clinical trial batches of Generex Oral-lyn™.
We have contracted with our third-party manufacturers for sufficient quantities
of the RapidMist™ device components, the insulin, and the formulary excipients
that will be required for the production of clinical trial batches of Generex
Oral-lyn™. We also recently entered into licensing and distribution agreement
with multinational distributors to initiate the regulatory approval and
commercialization process for Generex Oral-lyn™ in 15 Middle Eastern countries
and the Republic of Armenia, Georgia and the Republic of Kazakhstan. We also
entered into a distribution agreement for Glucose RapidSpray™, GlucoBreak™ and
BaBOOM!™ Energy Spray in 15 Middle Eastern countries. Additionally, we have also
entered into a distribution agreement for Glucose RapidSpray ™ in South Africa
and six neighboring countries. Under the terms of these agreements, we will
not
receive an upfront licensing fee, but the distributors will bear all the costs
associated with procuring governmental approvals, including any clinical or
regulatory costs.
35
In
the
next fiscal year, we also plan to continue with the commercialization of Generex
Oral-lyn™ in Ecuador and efforts to obtain regulatory approval of this product
in other countries using the approved Ecuadorian dossier. Our business partner
for the commercialization of Generex Oral-lyn™ in Ecuador, PharmaBrand, expects
additional commercial manufacturing runs of the product at its facilities in
Quito, Ecuador in the second half of calendar year 2007. Currently, our
relationship with PharmaBrand is governed by a letter of intent, and we are
in
the process of transitioning PharmaBrand’s role into one of a third-party
manufacturer with distribution rights for Ecuador. PharmaBrand has generated
some commercial sales of Generex Oral-lyn™ in Ecuador to date. We expect to
receive revenues from such sales sometime in fiscal 2008, but we do not expect
that such sales will be reflected in our financial statements until we have
entered into a definitive licensing and distribution agreement with PharmaBrand.
We
face
competition from other providers of alternate forms of insulin, including Pfizer
which has an inhalable form of insulin, marketed as Exubera®. Since May 2006,
Pfizer has launched Exubera® in Germany, Ireland, the U.K. and the U.S. Although
initial supplies of Exubera® were available across the U.S. beginning in
September 2006, Pfizer has expressed disappointment with its slow acceptance.
In
the U.S., Pfizer began branded direct-to-consumer advertising of Exubera® in
print ads in mid-June 2007 and television ads in July 2007. We believe that
our
buccal delivery technology offers several advantages over alternate forms of
insulin.
We
continue clinical development of Antigen’s synthetic peptide vaccines designed
to stimulate a potent and specific immune response against tumors expressing
the
HER-2/neu oncogene for patients with stage II HER-2/neu positive breast cancer
and patients with prostate cancer and against avian influenza. In May 2007,
the
first breast cancer patients received treatment in the Phase II clinical trial
of the Antigen peptide vaccine. This trial is being conducted with the United
States Military Cancer Institute Clinical Trials Group under the direction
of
Colonel George Peoples, M.D. The trial will measure the rate of relapse after
two years in breast cancer patients who have completed standard therapy for
node-positive or high-risk node-negative breast cancer expressing at least
low
levels of the HER-2/neu oncogene and who are at increased risk for recurrence.
Euroclinic, a private center in Athens, Greece, has commenced clinical trials
with the same compound as an immunotherapeutic vaccine for prostate cancer
in
fiscal 2007. The Lebanese-Canadian Hospital in Beirut, Lebanon commenced a
Phase
I clinical trial of the Antigen synthetic avian influenza vaccine in April
2007.
In
addition, Antigen recently entered into an agreement with Beijing Daopei
Hospital in Beijing, China to conduct clinical trials using Antigen’s novel
immunotherapeutic strategy involving RNA interference to modify a patient’s
cancer cells to increase their immunogenicity to enable the immune system to
fight cancer anywhere in the patient’s body.
We
also
expect to continue joint development activities with Fertin Pharma A/S with
respect to a metformin medicinal chewing gum for the treatment of Type-2
diabetes mellitus and obesity.
Accounting
for Research and Development Projects
Our
major
research and development projects are the refinement of our platform buccal
delivery technology, our buccal insulin project (Generex Oral-lyn™), our buccal
morphine product and Antigen’s peptide immunotherapeutic vaccines.
During
the last fiscal year, we expended resources on the clinical testing and
commercialization, of our buccal insulin product, Generex Oral-lyn™. In July
2007, we received no objection from the FDA to proceed with our long-term
multi-center Phase III study protocol for Generex Oral-lyn™. Late-stage trials
involve testing our product with a large number of patients over a significant
period of time. The completion of late-stage trials in Canada and eventually
the
United States may require significantly greater funds than we currently have
on
hand.
Generex
Oral-lyn™ was approved for commercial sale by drug regulatory authorities in
Ecuador in May 2005. PharmaBrand handled the commercial launch of Generex
Oral-lyn™ in Ecuador in June 2006. During the last fiscal year, 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. While we anticipate generating revenue from sales
of Generex Oral-lyn™ in Ecuador in fiscal 2008, we do not expect that such
revenues will be sufficient to sustain our research and development and
regulatory activities.
36
Although
we initiated regulatory approval process for our morphine buccal product, we
did
not expend resources to further this product during our last fiscal year.
During
the last fiscal year, we expended resources on research and development relating
to Antigen’s peptide immunotherapeutic vaccines and related technologies. One
Antigen vaccine is currently in Phase II clinical trials in the United States
involving patients with HER-2/neu positive breast cancer, and an Antigen vaccine
for H5N1 avian influenza is in Phase I clinical trials conducted at the
Lebanese-Canadian Hospital in Beirut. Antigen’s prostate cancer vaccine based on
AE37 is currently in Phase I clinical trials in Greece.
Because
of various uncertainties, we cannot predict the timing of completion and
commercialization of our buccal insulin or buccal morphine products or Antigen’s
peptide immunotherapeutic vaccines or related technologies. These uncertainties
include the success of current studies, our ability to obtain the required
financing and the time required to obtain regulatory approval even if our
research and development efforts are completed and successful, our ability
to
enter into collaborative marketing and distribution agreements with
third-parties, and the success of such marketing and distribution arrangements.
For the same reasons, we cannot predict when any products may begin to produce
net cash inflows.
Most
of
our buccal delivery research and development activities to date have involved
developing our platform technology for use with insulin 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 fiscal
2007, approximately 73% of our $11,983,626 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 fiscal 2006,
approximately 82% of our $6,554,393 in research expenses was attributable to
insulin and platform technology development, and we did not have any research
expenses related to morphine or other buccal projects.
Approximately
27% or $3,181,927 of our research and development expenses for the fiscal year
ended July 31, 2007 was related to Antigen's immunomedicine products
compared to approximately 18% or $1,155,331 for the fiscal year ended
July 31, 2006. Because these products are in initial phases of clinical
trials or early, pre-clinical stage of development, 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
Year
Ended July 31, 2007 Compared to Year Ended July 31, 2006
We
had a
net loss of $23,504,958 for the year ended July 31, 2007 (fiscal 2007) compared
to a net loss of $67,967,204 for the year ended July 31, 2006 (fiscal 2006).
The
decrease in net loss for fiscal 2007 is attributable to the fact that in fiscal
2007 we did not have interest expense and loss on extinguishment of debt similar
to that which we incurred during fiscal 2006 fiscal year in connection with
the
issuance of convertible debentures. Our operation loss for fiscal 2007 increased
to $24,876,102 compared to $18,705,983 in operating loss for fiscal 2006. The
increase in our fiscal 2007 operating loss resulted from a significant increase
in research and development expenses (to $11,983,626 from $6,554,393), an
increase in our selling and marketing expenses (to $693,309 from $56,028) and
a
slight increase in general and administrative expenses (to $12, 317,742 from
$12,270,562). Our revenue, excluding the deferred revenue, increased slightly
from $175,000 in fiscal 2006 to $180,198 in fiscal 2007 and is attributable
to
the sales of our over-the-counter products.
The
increase in general and administrative expenses for fiscal 2007 is due primarily
to the increase of non cash compensation to financial consultants in fiscal
2007
compared to compensation paid in 2006, an increase in legal, litigation and
accounting expenses and an increase in travel. The increase was offset by the
reduction in executive and director compensation and the decrease in office
and
general expenses.
37
The
increase in research and development expenses for fiscal 2007 reflects increased
levels of research and development activities in connection with commencement
of
Phase III clinical trials in Canada and higher level of clinical activities
of
Antigen.
Our
interest expense in fiscal 2007 decreased to $849,548, compared to interest
expense of $37,715,275 in fiscal 2006 relating to interest paid in connection
with convertible debentures entered into during the last fiscal year. Our
interest and miscellaneous income increased to $2,180,380 in fiscal 2007,
compared to $768,098 in fiscal 2006, primarily due to substantially higher
cash
and short term investment balances during fiscal 2007. Our loss on
extinguishment of debt, also incurred in connection with convertible debentures,
was $237,162 in fiscal 2007, compared to $12,550,565 in fiscal 2006. We received
a slightly higher income from rental operations (net of expense) of $277,474
in
fiscal 2007, compared to $236,521 in fiscal 2006.
Results
of Operations
Year
Ended July 31, 2006 Compared to Year Ended July 31, 2005
We
had a
net loss of $67,967,204 for the year ended July 31, 2006 (fiscal 2006) compared
to a net loss of $24,001,735 for the year ended July 31, 2005 (fiscal 2005).
The
increase in net loss for the 2006 fiscal year was attributable mainly to
interest expense and loss on extinguishment of debt incurred in connection
with
convertible debentures entered during the 2006 fiscal year. Our operation loss
for fiscal 2006 increased slightly to $18,705,983 compared to $18,558,421 in
operating loss for fiscal 2005. The increase in our fiscal 2006 operating loss
resulted from an increase in general and administrative expenses (to $12,270,562
from $11,199,802), and a decrease in research and development expenses (to
$6,554,393 from $7,750,731). Our revenue had decreased from $392,112 in fiscal
2005 to $175,000 in fiscal 2006.
The
increase in general and administrative expenses for fiscal 2006 was due
primarily to the increase of non cash compensation to financial consultants
in
fiscal 2006 compared to compensation paid in 2005 and an increase in executive
compensation. Our consulting services, travel and advertising expenses also
contributed to an increase in general and administrative expenses despite the
decrease in office and general expenses.
The
decrease in research and development expenses for fiscal 2006 reflected
decreased level of research and development activities and fewer clinical trials
of our oral insulin formulation despite the increase in the activities of
Antigen.
Our
interest expense in fiscal 2006 increased to $37,715,275 compared to interest
expense of $4,376,043 in fiscal 2005 due to interest paid in connection with
convertible debentures entered into during fiscal 2006. Our interest and
miscellaneous income increased to $768,098 in fiscal 2006 compared to $93,213
in
fiscal 2005 primarily due to substantially higher cash and short term investment
balances during the current fiscal year. Our loss on extinguishment of debt,
also incurred in connection with convertible debentures, was $12,550,565 in
fiscal 2006 compared to $1,346,341 in fiscal 2005. We received a slightly higher
income from rental operations (net of expense) of $236,521 in fiscal 2006
compared to $185,857 in fiscal 2005.
Developments
in Fiscal Year 2007
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. These studies are currently underway.
In
September 2006, we executed a clinical supply agreement and a related quality
agreement with Cardinal Health PTS, LLC, now known as Catalant Pharma Solutions.
We have contracted with Catalant Pharma Solutions for the manufacture of
clinical trial batches of our oral insulin product, Generex
Oral-lyn™.
38
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. The study is being undertaken with the approval
of
the appropriate Lebanese governmental and regulatory bodies.
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. In April 2007, the Lebanese-Canadian Hospital in Beirut,
Lebanon commenced a Phase I clinical trial of the Antigen synthetic avian
influenza vaccine. The study is being undertaken with the approval of the
appropriate Lebanese governmental and regulatory bodies.
In
February 2007, in conjunction with the United States Military Cancer Institute’s
Clinical Trials Group, we entered into a Phase II clinical trial using the
Antigen peptide vaccine in breast cancer patients who have completed standard
therapy for node-positive or high-risk node-negative breast cancer expressing
at
least low levels of the HER-2/neu oncogene and who are at increased risk for
recurrence.
In
March
2007, Antigen entered into an agreement with Beijing Daopei Hospital in Beijing,
China to conduct clinical trials using Antigen’s pioneering technology for RNA
interference (RNAi) stimulation of the immune response against patients’ immune
cells.
In
April
2007, we entered into a licensing and distribution agreement with Leosons
General Trading Company, a leading distributor of North American pharmaceutical
and healthcare products in the Middle East, for the commercialization of Generex
Oral-lyn™ in 15 Middle Eastern countries, including Saudi Arabia and the United
Arab Emirates. Under this agreement, we will not receive an upfront license
fee,
but Leosons will bear all costs associated with the procurement of governmental
approvals for the sale of the product, including any clinical and regulator
costs. Leosons is obligated to file all requisite applications for such
approvals by the fall of 2007. In April 2007, we also entered into a licensing
and distribution agreement with Leosons for the distribution of Glucose
RapidSpray™ in the same 15 Middle Eastern countries.
In
May
2007, we introduced two new products in our line of over-the-counter glucose
sprays, BaBOOM!™ Energy Spray and GlucoBreak™ dietary aid spray.
In
July
2007, we entered into a licensing and distribution agreement with the Armenian
Development Agency and the Canada Armenia Trading House Ltd. for the
commercialization of Generex Oral-lyn™ in the Republic of Armenia, Georgia and
the Republic of Kazakhstan. While we will receive no upfront fee under this
agreement, the distributors will bear any and all costs associated with the
procurement of governmental approvals for the sale of Generex Oral-Lyn™,
including any clinical and regulatory costs.
In
September 2007, we entered into a licensing and distribution agreement with
Adcock Ingram LLP and Adcock Ingram Healthcare (Pty) Ltd., a leading distributor
of North American pharmaceutical and healthcare products in South Africa, for
the marketing and distribution of Glucose RapidSpray ™ in South Africa and six
neighboring countries. Under this agreement, we will not receive an upfront
license fee, but Adcock Ingram will bear all costs associated with the
procurement of governmental approvals for the sale of the product, including
any
clinical and regulator costs.
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.
39
During
the fiscal year ended July 31, 2007, we did not engage in any capital-raising
transactions. At July 31, 2007, we had cash and short-term investments of
approximately $35.0 million, a decrease of $17.5 million from the balance as
of
the end of the prior fiscal year. As of July 31, 2007, we believed that our
anticipated cash position was sufficient to meet our working capital needs
for
the next twelve months based on the pace of our planned activities. Beyond
that,
we may require additional funds to support our working capital requirements
or
for other purposes. Management plans to meet our operating cash flow
requirements through financing activities, such as private placement of our
common stock, preferred stock offerings and offerings of debt and convertible
debt instruments. Management is also actively pursuing industry collaboration
activities, including product licensing and specific project financing. While
we
have generally been able to raise equity capital as required, our cash balances
were very low during portions of fiscal 2005 and unforeseen problems with our
clinical program 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.
As
of
July 31, 2007, all outstanding 6% secured convertible debentures that we issued
in connection with the Securities Purchase Agreement dated November 10, 2004
and
amendments thereto have been either repaid or converted to shares of our common
stock and the related debt discounts have been fully amortized. Since November
2004, we have issued an aggregate of 20,580,978 shares of common stock resulting
from the conversion and repayment of an aggregate of $17,613,894 of debenture
principal and accrued interest issued under the auspices of the Securities
Purchase Agreement dated November 10, 2004 and amendments thereto.
At
July
31, 2007, the following warrants issued under the auspices of the Securities
Purchase Agreement dated November 10, 2004 and amendments thereto and the
Securities Purchase Agreement dated June 1, 2006 were outstanding:
Date
Issued
|
Aggregate
No.
of
Shares Unexercised
|
Exercise
Price*
|
Exercise
Date
|
Expiration
Date
|
|||||||||
January
23, 2006
|
622,226
|
$
|
1.60
|
June
2, 2006
|
July
22, 2011
|
||||||||
February
27, 2006
|
4,770,617
|
$
|
3.00
|
August
27, 2006
|
August
27, 2011
|
||||||||
February.
28, 2006
|
172,120
|
$
|
1.25
|
August
31, 2006
|
August
31, 2011
|
||||||||
March
1, 2006
|
800,000
|
$
|
3.00
|
September
6, 2006
|
September
6, 2011
|
||||||||
June
1, 2006
|
2,560,980
|
$
|
2.45
|
June
1, 2006
|
June
1, 2011
|
||||||||
June
2, 2006
|
3,273,144
|
$
|
2.35
|
June
2, 2006
|
June
2, 2011
|
*subject
to anti-dilution adjustments upon issuance of securities at a price per share
of
common stock less than the then applicable exercise price or the market price
of
our common stock at that time, whichever is lower
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:
40
Revenue
Recognition.
Net
sales of Glucose RapidSpray™, BaBOOM!™ Energy Spray and GlucoBreak™ are
generally recognized in the period in which the products are delivered. Delivery
of the products generally completes the criteria for revenue recognition for
the
Company. In the event where the customers have the right of return, sales are
deferred until the right of return lapses or the product is resold.
Inventory.
Inventories
are stated at the lower of cost or market with cost determined using the
first-in first-out method. Management considers such factors as the amount
of
inventory on hand and in the distribution channel, estimated time to sell such
inventory, inventories shelf life and current market conditions when determining
whether the lower cost or market is used. As appropriate, a provision is
recorded to reduce inventories to their net realizable value. Inventory also
includes the cost of products sold to the customers with the rights of
return.
Impairment
of Long-Lived Assets.
Management reviews for impairment whenever events or changes in circumstances
indicate that the carrying amount of property and equipment may not be
recoverable under the provisions of Statement of Financial Accounting Standards
No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets."
If it
is determined that an impairment loss has occurred based upon expected future
cash flows, the loss is recognized in the Statement of Operations.
Intangible
Assets.
We have
intangible assets related to patents. The determination of the related estimated
useful lives and whether or not these assets are impaired involves significant
judgments. In assessing the recoverability of these intangible assets, we use
an
estimate of undiscounted operating income and related cash flows over the
remaining useful life, market conditions and other factors to determine the
recoverability of the asset. If these estimates or their related assumptions
change in the future, we may be required to record impairment charges against
these assets.
Estimating
accrued liabilities, specifically litigation accruals.
Management's current estimated range of liabilities related to pending
litigation is based on management's best estimate of future costs. While the
final resolution of the litigation could result in amounts different than
current accruals, and therefore have an impact on our consolidated financial
results in a future reporting period, management believes the ultimate outcome
will not have a significant effect on our consolidated results of operations,
financial position or cash flows.
Off-Balance
Sheet Arrangements
We
have
no off-balance sheet arrangements that have or are reasonably likely to have
a
current or future effect on the Company’s financial condition, changes in
financial condition, revenue or expenses, results of operations, liquidity,
capital expenditures or capital resources that is material to investors, and
we
do not have any non-consolidated special purpose entities.
Contractual
Obligations
|
Payments
Due by Period
|
|||||||||||||||
Contractual
Obligations
|
Total
|
Less
than
1year
|
1-3
years
|
3-5
years
|
More
than
5
years
|
|||||||||||
Long-Term
Debt Obligations
|
3,143,789
|
84,503
|
2,412,761
|
646,525
|
0
|
|||||||||||
Capital
Lease Obligations
|
0
|
0
|
0
|
0
|
0
|
|||||||||||
Operating
Lease Obligations
|
589,211
|
148,823
|
256,079
|
183,812
|
497
|
|||||||||||
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
|
$
|
3,733,001
|
$
|
233,327
|
$
|
2,668,839
|
$
|
830,338
|
$
|
497
|
41
Prior
to
January 1, 1999, a portion of our general and administrative expenses resulted
from transactions with affiliated persons, and a number of capital transactions
also involved affiliated persons. Although these transactions were not the
result of "arms-length" negotiations, we do not believe that this fact had
a
material impact on our results of operations or financial position. Prior to
December 31, 1998, we classified certain payments to executive officers for
compensation and expense reimbursements as "Research and Development - related
party" and "General and Administrative - related party" because the executive
officers received such payments through personal services corporations rather
than directly. After December 31, 1998, these payments have been and will
continue to be accounted for as though the payments were made directly to the
officers, and not as a related party transaction. With the exception of our
arrangement with our management company described below, we do not foresee
a
need for, and therefore do not anticipate, any related party transactions in
the
current fiscal year.
On
May 3,
2001, we advanced $334,300 to each of three senior officers, who are also our
stockholders, in exchange for promissory notes. These notes bore interest at
8.5% per annum and were payable in full on May 1, 2002. These notes were
guaranteed by a related company owned by these officers and secured by a pledge
of 2,500,000 shares of our common stock owned by this related company. On June
3, 2002, our Board of Directors extended the maturity date of the loans to
October 1, 2002. The other terms and conditions of the loans and guaranty
remained unchanged and in full force and effect. As of July 31, 2002, the
balance outstanding on these notes, including accrued interest, was $1,114,084.
Pursuant to a decision made by the Compensation Committee as of August 30,
2002,
these loans were satisfied through the application of 592,716 shares of pledged
stock, at a value of $1.90 per share, which represented the lowest closing
price
during the sixty days prior to August 30, 2002.
On
December 9, 2005, our Board of Directors approved a one-time recompense payment
in the aggregate amount of $1,000,000 for each of Ms. Gluskin, our Chairwoman,
Chief Executive Officer and President, and Ms. Rose Perri, our Chief Operating
Officer, Chief Financial Officer, Treasurer and Secretary, in recognition of
the
company’s failure to remunerate each of Ms. Gluskin and Ms. Perri in each of the
fiscal years ended July 31, 1998, 1999, 2000 and 2001 in a fair and reasonable
manner commensurate with comparable industry standards and Ms. Gluskin’s and Ms.
Perri’s duties, responsibilities and performance during such years. The payment
of such amount to each of Ms. Gluskin and Ms. Perri will be made (a) in cash
at
such time or times and in such amounts as determined solely by Ms. Gluskin
or
Ms. Perri, as applicable, and/or (b) in shares of our common stock at such
time
or times as determined by Ms. Gluskin or Ms. Perri, as applicable, provided
that
the conversion price for any such shares shall be equal to the average closing
price of our common stock on the NASDAQ Capital Market for the 20 successive
trading days immediately preceding, but not including, December 9, 2005. The
amounts were not paid as of July 31, 2007 with the exception of $415,742.30
that
was used by Ms. Perri to repay Note Receivable, Due from Related Party. The
amount was due from EBI, Inc., a shareholder of the Company that is controlled
by the estate of the Company’s former Chairman of the Board, Mark Perri. The
note was not interest bearing, unsecured and did not have any fixed terms of
repayment. The note was extended to EBI, Inc. in May 1997.
Real
Estate Transactions:
On
August 7, 2002, we purchased real estate with an aggregate purchase price of
approximately $1.6 million from an unaffiliated party. In connection with that
transaction, Angara Enterprises, Inc., a licensed real estate broker that is
an
affiliate of Ms. Gluskin received a commission from the proceeds of the sale
to
the seller in the amount of 3% of the purchase price, or $45,714. We believe
that this is less than the aggregate commission which would have been payable
if
a commission had been negotiated with an unaffiliated broker on an arm's length
basis.
On
December 9, 2005, our Board of Directors approved the grant to Ms. Perri of
a
right of first refusal in respect of any sale, transfer, assignment or other
disposition of either or both real properties municipally known as 1740 Sismet
Road, Mississauga, Ontario and 98 Stafford Drive, Brampton, Ontario
(collectively, the “Properties”). We granted Ms. Perri this right in recognition
of the fair market value transfer to us during the fiscal year ended July 31,
1998 by Ms. Perri (or parties related to her) of the Properties.
We
utilize a management company to manage all of our real properties. The property
management company is owned by Ms. Perri, Ms. Gluskin and the estate of Mark
Perri, our former Chairman of the Board. In the fiscal years ended July 31,
2007
and 2006, we paid the management company approximately $47,832 and $46,133,
respectively, in management fees.
42
Legal
Fees.
David
Wires, a former director, is a partner of the firm Wires Jolley LLP. Wires
Jolley represents us in various matters. During fiscal 2007, we paid
approximately $95,000 in fees to Wires Jolley. We continue to use Wires Jolley
and expect to pay legal fees in similar amounts to the firm in fiscal 2008.
Mr.
Wires elected not to stand for re-election at our annual meeting of stockholders
which was held on May 29, 2007.
Consulting
Fees.
Peter
Amanatides, one of our directors, is the Senior Vice-President and Chief
Operating Officer of PharmaLogika, Inc., a private consulting firm in the
pharmaceuticals regulatory field. During fiscal year 2007, Generex paid $100,000
in fees to PharmaLogika for services rendered, and we owe a balance of $50,000.
We do not expect to pay any further fees to PharmaLogika going forward. Mr.
Amanatides is neither a director nor a shareholder of PharmaLogika.
New
Accounting Pronouncements
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" ("SFAS
157"). SFAS 157 defines fair value, establishes a framework for measuring fair
value in accordance with accounting principles generally accepted in the United
States, and expands disclosures about fair value measurements. SFAS No. 157
is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, with earlier application encouraged. Any amounts recognized
upon adoption as a cumulative effect adjustment will be recorded to the opening
balance of retained earnings in the year of adoption. We are currently
evaluating the impact of this statement on our results of operations or
financial position.
In
February 2007, the FASB issued SFAS No. 159, “Establishing the Fair Value Option
for Financial Assets and Liabilities” to permit all entities to choose to elect
to measure eligible financial instruments at fair value. The decision whether
to
elect the fair value option may occur for each eligible item either on a
specified election date or according to a preexisting policy for specified
types
of eligible items. However, that decision must also take place on a date on
which criteria under SFAS 159 occurs. Finally, the decision to elect the fair
value option shall be made on an instrument-by-instrument basis, except in
certain circumstances. An entity shall report unrealized gains and losses on
items for which the fair value option has been elected in earnings at each
subsequent reporting date. SFAS No. 159 applies to fiscal years beginning after
November 15, 2007, with early adoption permitted for an entity that has also
elected to apply the provisions of SFAS No. 157, Fair Value Measurements. We
are
currently evaluating the impact of this statement on our results of operations
or financial position.
Item.
7A. 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, and 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.
43
As
of
July 31, 2007, we had fixed rate debt totaling $3,143,789. This amount consists
of the following:
Loan
Amount
|
|
Interest
Rate
per
Annum
|
|
441,380
|
|
|
6.82%
|
273,666
|
|
|
6.82%
|
667,943
|
|
|
7.60%
|
375,120
|
|
|
8.50%
|
210,371
|
|
|
10%
|
1,175,309
|
|
|
6.07%
|
3,143,789
|
|
|
Total
|
These
debt instruments mature from August 2008 through June 2011. As our fixed rate
debt instruments mature, we will likely refinance such debt at the existing
market interest rates which may be more or less than interest rates on the
maturing debt. Since this debt is fixed rate debt, if interest rates were to
increase 100 basis points prior to maturity, there would be no impact on
earnings or cash flows.
We
have
neither issued nor own any long-term debt instruments, or any other financial
instruments, for trading purposes and as to which we would be subject to
material market risks.
Item
8. Financial
Statements and Supplementary Data.
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Page
|
|
Report
of Independent Registered Public Accounting Firms
|
F-1
- F-3
|
Consolidated
Balance Sheets
|
|
July
31, 2007
and 2006
|
F-4
|
Consolidated
Statements of Operations
|
|
For
the Years Ended July 31, 2007,
2006
and 2005
|
|
and
Cumulative From Inception to July 31, 2007
|
F-5
|
Consolidated
Statements of Changes in Stockholders’ Equity
|
|
For
the Period November 2, 1995 (Date of Inception)
|
|
to
July 31, 2007
|
F-6
- F-25
|
Consolidated
Statements of Cash Flows
|
|
For
the Years Ended July 31, 2007,
2006
and 2005
|
|
and
Cumulative From Inception to July 31, 2007
|
F-26
- F-27
|
Notes
to Consolidated Financial Statements
|
F-28
- F-55
|
44
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board
of
Directors and Shareholders of
Generex
Biotechnology Corporation
(A
Development Stage Company)
We
have
audited the accompanying consolidated balance sheets of Generex Biotechnology
Corporation (a development stage company) as of July 31, 2007 and 2006 and
the
related consolidated statements of operations, stockholders’ equity, and cash
flows for each of the years in the two-year period ended July 31, 2007. We
also
have audited management’s assessment, included in the accompanying Management’s
Annual Report on Internal Control Over Financial Reporting, that Generex
Biotechnology Corporation maintained effective internal control over financial
reporting as of July 31, 2007, based on criteria established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO). Generex Biotechnology Corporation’s
management is responsible for these financial statements, for maintaining
effective internal control over financial reporting, and for its assessment
of
the effectiveness of internal control over financial reporting. Our
responsibility is to express an opinion on these financial statements, an
opinion on management’s assessment, and an opinion on the effectiveness of the
company’s internal control over financial reporting based on our audits. We did
not audit the consolidated financial statements of Generex Biotechnology
Corporation for the period from November 2, 1995 (date of inception) to July
31,
2005. Those statements were audited by other auditors whose report has been
furnished to us and our opinion, insofar as it relates to amounts for the
period
from November 2, 1995 (date of inception) to July 31, 2005, included in
cumulative totals, is based solely upon the reports of other
auditors.
We
conducted our audits, referred to above, in accordance with the standards
of the
Public Company Accounting Oversight Board (United States). Those standards
require that we plan and perform the audit to obtain reasonable assurance
about
whether the financial statements are free of material misstatement and whether
effective internal control over financial reporting was maintained in all
material respects. An audit of financial statements includes examining, on
a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. An audit of internal control over financial
reporting includes obtaining an understanding of internal control over financial
reporting, evaluating management’s assessment, testing and evaluating the design
and operating effectiveness of internal control, and performing such other
procedures we consider necessary in the circumstances. We believe that our
audits provide reasonable bases for our opinions.
F-1
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain
to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary
to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company
are
being made only in accordance with authorizations of management and directors
of
the company; and (3) provide reasonable assurance regarding prevention or
timely
detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may
become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In
our
opinion, the consolidated financial statements referred to above present
fairly,
in all material respects, the financial position of Generex Biotechnology
Corporation as of July 31, 2007 and 2006, and the results of its operations
and
its cash flows for each of the years in the two-year period ended July 31,
2007
in conformity with accounting principles generally accepted in the United
States
of America. Also, in our opinion, management’s assessment that Generex
Biotechnology Corporation maintained effective internal control over financial
reporting as of July 31, 2007, is fairly stated, in all material respects,
based
on criteria established in Internal Control—Integrated Framework issued by COSO.
Furthermore, in our opinion, Generex Biotechnology Corporation maintained,
in
all material respects, effective internal control over financial reporting
as of
July 31, 2007, based on criteria established in Internal Control—Integrated
Framework issued by COSO.
Our
audits were conducted for the purpose of forming an opinion on the basic
consolidated financial statements taken as a whole. Schedule II is presented
for
purposes of additional analysis and is not a required part of the basic
consolidated financial statements. This schedule has been subjected to the
auditing procedures applied to the basic consolidated financial statements
and,
in our opinion, is fairly stated in all material respects in relation to
the
basic consolidated financial statements taken as a whole.
/s/
Danziger Hochman Partners LLP
Toronto,
Canada
October
3, 2007
F-2
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board
of
Directors and Stockholders
Generex
Biotechnology Corporation
(A
Development Stage Company)
We
have
audited the accompanying consolidated balance sheet of Generex Biotechnology
Corporation (a development stage company) as of July 31, 2005 and the related
consolidated statements of operations, stockholders’ equity, and cash flows for
the year then ended. We have also audited Schedule II. These financial
statements and schedule are the responsibility of the Company’s management. Our
responsibility is to express an opinion on these financial statements based
on
our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements and Schedule II are free of material misstatement. The Company
is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audit included consideration of internal
control over financial reporting as a basis for designing audit procedures
that
are appropriate in the circumstances, but not for the purpose of expressing
an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements and Schedule II, assessing the accounting principles
used and significant estimates made by management, as well as evaluating
the
overall financial statement and schedule presentation. We believe that our
audit
provides a reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present
fairly,
in all material respects, the financial position of Generex Biotechnology
Corporation (a development stage company) at July 31, 2005 and the results
of
its operations and its cash flows the year then ended, in conformity with
accounting principles generally accepted in the United States of
America.
Also,
in
our opinion, Schedule II presents fairly, in all material respects, the
information set forth therein.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company has suffered recurring net losses and negative cash
flows from operations and has a working capital deficiency. These matters
raise
substantial doubt about its ability to continue as a going concern. Management’s
plans in regard to these matters are also described in Note 1. The financial
statements do not include any adjustments that might result from the outcome
of
this uncertainty.
/s/
BDO
Dunwoody LLP
Toronto,
Ontario
September
30, 2005
F-3
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
|||
(A
DEVELOPMENT STAGE COMPANY)
|
|||
CONSOLIDATED
BALANCE SHEETS
|
July
31,
|
|
||||||
|
|
2007
|
|
2006
|
|||
ASSETS
|
|||||||
Current
Assets:
|
|||||||
Cash
and cash equivalents
|
$
|
21,026,067
|
$
|
38,208,493
|
|||
Short-term
investments
|
14,011,738
|
14,372,653
|
|||||
Accounts
receivable
|
58,264
|
—
|
|||||
Inventory
|
123,931
|
—
|
|||||
Other
current assets
|
469,210
|
237,752
|
|||||
Total
Current Assets
|
35,689,210
|
52,818,898
|
|||||
Property
and Equipment, Net
|
2,137,027
|
2,585,744
|
|||||
Assets
Held for Investment, Net
|
3,693,183
|
3,602,773
|
|||||
Patents,
Net
|
4,884,984
|
5,097,827
|
|||||
TOTAL
ASSETS
|
$
|
46,404,404
|
$
|
64,105,242
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
Liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
7,156,709
|
$
|
5,444,790
|
|||
Deferred
revenue
|
33,314
|
—
|
|||||
Current
maturities of long-term debt
|
84,503
|
428,059
|
|||||
Convertible
debentures, net of debt discount of $-0- and $608,737
|
|||||||
at
July 31, 2007 and 2006, respectively
|
—
|
160,494
|
|||||
Total
Current Liabilities
|
7,274,526
|
6,033,343
|
|||||
Long-Term
Debt, Net
|
3,059,286
|
2,608,105
|
|||||
Commitments
and Contingencies
|
|||||||
Stockholders’
Equity:
|
|||||||
Special
Voting Rights Preferred Stock, $.001 par value;
|
|||||||
authorized
1,000 shares at July 31, 2007 and 2006; -0- and 1,000
shares
|
|||||||
issued
and outstanding at July 31, 2007 and 2006, respectively
|
—
|
1
|
|||||
Common
stock, $.001 par value; authorized 500,000,000 shares at July 31,
2007
|
|||||||
and
2006; 109,616,518 and 107,398,360 shares issued and outstanding
at
|
|||||||
July
31, 2007 and 2006, respectively
|
109,616
|
107,397
|
|||||
Additional
paid-in capital
|
247,079,439
|
243,097,627
|
|||||
Deficit
accumulated during the development stage
|
(212,000,270
|
)
|
(188,495,312
|
)
|
|||
Accumulated
other comprehensive income
|
881,807
|
754,081
|
|||||
Total
Stockholders’ Equity
|
36,070,592
|
55,463,794
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
46,404,404
|
$
|
64,105,242
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-4
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
|||||||||||||||||
(A
DEVELOPMENT STAGE COMPANY)
|
|||||||||||||||||
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
Cumulative
From
|
|
||||||
|
|
|
|
|
|
|
|
November
2, 1995
|
|||||
(Date
of Inception)
|
|||||||||||||
For
the Years Ended July 31,
|
to
July 31,
|
||||||||||||
2007
|
|
2006
|
|
2005
|
|
2007
|
|||||||
Revenues
|
$
|
182,429
|
$
|
175,000
|
$
|
392,112
|
$
|
2,376,725
|
|||||
Sales
discounts
|
(2,231
|
)
|
—
|
—
|
(2,231
|
)
|
|||||||
Net
Revenue
|
180,198
|
175,000
|
392,112
|
2,374,494
|
|||||||||
Cost
of Goods Sold
|
61,623
|
—
|
—
|
61,623
|
|||||||||
Operating
Expenses:
|
|||||||||||||
Research
and development
|
11,983,626
|
6,554,393
|
7,750,731
|
73,456,464
|
|||||||||
Research
and development -
|
|||||||||||||
related
party
|
—
|
—
|
—
|
220,218
|
|||||||||
Selling
and marketing
|
693,309
|
56,028
|
—
|
749,337
|
|||||||||
General
and administrative
|
12,317,742
|
12,270,562
|
11,199,802
|
90,039,418
|
|||||||||
General
and administrative -
|
|||||||||||||
related
party
|
—
|
—
|
—
|
314,328
|
|||||||||
Total
Operating Expenses
|
24,994,677
|
18,880,983
|
18,950,533
|
164,779,765
|
|||||||||
Operating
Loss
|
(24,876,102
|
)
|
(18,705,983
|
)
|
(18,558,421
|
)
|
(162,466,894
|
)
|
|||||
Other
Income (Expense):
|
|||||||||||||
Miscellaneous
income (expense)
|
—
|
500
|
70,345
|
196,193
|
|||||||||
Income
from Rental Operations, net
|
277,474
|
236,521
|
185,857
|
920,928
|
|||||||||
Interest
income
|
2,180,380
|
767,598
|
22,868
|
6,342,458
|
|||||||||
Interest
expense
|
(849,548
|
)
|
(37,715,275
|
)
|
(4,376,043
|
)
|
(43,602,015
|
)
|
|||||
Loss
on extinguishment of debt
|
(237,162
|
)
|
(12,550,565
|
)
|
(1,346,341
|
)
|
(14,134,068
|
)
|
|||||
Net
Loss Before Undernoted
|
(23,504,958
|
)
|
(67,967,204
|
)
|
(24,001,735
|
)
|
(212,743,398
|
)
|
|||||
Minority
Interest Share of Loss
|
—
|
—
|
—
|
3,038,185
|
|||||||||
Net
Loss
|
(23,504,958
|
)
|
(67,967,204
|
)
|
(24,001,735
|
)
|
(209,705,213
|
)
|
|||||
Preferred
Stock Dividend
|
—
|
—
|
—
|
2,295,057
|
|||||||||
Net
Loss Available to Common
|
|||||||||||||
Shareholders
|
$
|
(23,504,958
|
)
|
$
|
(67,967,204
|
)
|
$
|
(24,001,735
|
)
|
$
|
(212,000,270
|
)
|
|
Basic
and Diluted Net Loss Per
|
|||||||||||||
Common
Share
|
$
|
(.22
|
)
|
$
|
(.90
|
)
|
$
|
(.66
|
)
|
||||
Weighted
Average Number of Shares
|
|||||||||||||
of
Common Stock Outstanding
|
108,416,023
|
75,416,234
|
36,537,318
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-5
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
|
|
SVR
Preferred Stock
|
|
Common
Stock
|
|
Treasury
Stock
|
|
Additional
Paid-In
|
|
Notes
Receivable - Common
|
|
Deficit
Accumulated During the Development
|
|
Accumulated
Other Comprehensive
|
|
Total
Stockholders’
|
|
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Stock
|
|
Stage
|
|
Income
(Loss)
|
|
Equity
|
|
|||||||||||
Balance
November 2, 1995 (Inception)
|
-
|
$
|
-
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, February 1996, $.0254
|
-
|
-
|
321,429
|
321
|
-
|
-
|
7,838
|
-
|
-
|
-
|
8,159
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, February 1996, $.0510
|
-
|
-
|
35,142
|
35
|
-
|
-
|
1,757
|
-
|
-
|
-
|
1,792
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, February 1996, $.5099
|
-
|
-
|
216,428
|
216
|
-
|
-
|
110,142
|
-
|
-
|
-
|
110,358
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, March 1996, $10.2428
|
-
|
-
|
2,500
|
3
|
-
|
-
|
25,604
|
-
|
-
|
-
|
25,607
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, April 1996, $.0516
|
-
|
-
|
489,850
|
490
|
-
|
-
|
24,773
|
-
|
-
|
-
|
25,263
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, May 1996, $.0512
|
-
|
-
|
115,571
|
116
|
-
|
-
|
5,796
|
-
|
-
|
-
|
5,912
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, May 1996, $.5115
|
-
|
-
|
428,072
|
428
|
-
|
-
|
218,534
|
-
|
-
|
-
|
218,962
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, May 1996, $10.2302
|
-
|
-
|
129,818
|
130
|
-
|
-
|
1,327,934
|
-
|
-
|
-
|
1,328,064
|
|||||||||||||||||||||||
Issuance
of common stock for cash, July 1996, $.0051
|
-
|
-
|
2,606,528
|
2,606
|
-
|
-
|
10,777
|
-
|
-
|
13,383
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, July 1996, $.0255
|
-
|
-
|
142,857
|
143
|
-
|
-
|
3,494
|
-
|
-
|
-
|
3,637
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, July 1996, $.0513
|
-
|
-
|
35,714
|
36
|
-
|
-
|
1,797
|
-
|
-
|
-
|
1,833
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Issuance
of common stock for cash, July 1996, $10.1847
|
-
|
-
|
63,855
|
64
|
-
|
-
|
650,282
|
-
|
-
|
-
|
650,346
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Costs
related to issuance of common stock
|
-
|
-
|
-
|
-
|
-
|
-
|
(10,252
|
)
|
-
|
-
|
-
|
(10,252
|
)
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Founders
Shares transferred for services rendered
|
-
|
-
|
-
|
-
|
-
|
-
|
330,025
|
-
|
-
|
-
|
330,025
|
|||||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(693,448
|
)
|
-
|
(693,448
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss)
|
||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(4,017
|
)
|
(4,017
|
)
|
|||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(693,448
|
)
|
(4,017
|
)
|
(697,465
|
)
|
||||||||||||||||||||||||||||
Balance,
July 31, 1996
|
-
|
$
|
-
|
4,587,764
|
$
|
4,588
|
-
|
$
|
-
|
$
|
2,708,501
|
$
|
-
|
$
|
(693,448
|
)
|
$
|
(4,017
|
)
|
$
|
2,015,624
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-6
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|||||||||||
|
|
SVR
|
|
|
|
|
|
|
|
|
|
|
|
Notes
|
|
Accumulated
|
|
Accumulated
|
|
|
|
|||||||||||||
|
|
Preferred
|
|
Common
|
|
Treasury
|
|
Additional
|
|
Receivable-
|
|
During
the
|
|
Other
|
|
Total
|
|
|||||||||||||||||
|
|
Stock
|
|
Stock
|
|
Stock
|
|
Paid-In
|
|
Common
|
|
Development
|
|
Comprehensive
|
|
Stockholders’
|
|
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Stock
|
|
Stage
|
|
Income
(Loss)
|
|
Equity
|
|
|||||||||||
Balance,
August 1, 1996
|
-
|
$
|
-
|
4,587,764
|
$
|
4,588
|
-
|
$
|
-
|
$
|
2,708,501
|
$
|
-
|
$
|
(693,448
|
)
|
$
|
(4,017
|
)
|
$
|
2,015,624
|
|||||||||||||
Issuance
of common stock for cash, September 1996, $.0509
|
-
|
-
|
2,143
|
2
|
-
|
-
|
107
|
-
|
-
|
-
|
109
|
|||||||||||||||||||||||
Issuance
of common stock for cash, December 1996, $10.2421
|
-
|
-
|
1,429
|
1
|
-
|
-
|
14,635
|
-
|
-
|
-
|
14,636
|
|||||||||||||||||||||||
Issuance
of common stock for cash, January 1997, $.0518
|
-
|
-
|
1,466
|
1
|
-
|
-
|
75
|
-
|
-
|
-
|
76
|
|||||||||||||||||||||||
Issuance
of common stock for cash, March 1997, $10.0833
|
-
|
-
|
12
|
-
|
-
|
-
|
121
|
-
|
-
|
-
|
121
|
|||||||||||||||||||||||
Issuance
of common stock for cash, May 1997, $.0512
|
-
|
-
|
4,233
|
4
|
-
|
-
|
213
|
-
|
-
|
-
|
217
|
|||||||||||||||||||||||
Issuance
of common stock for cash, May 1997, $.5060
|
-
|
-
|
4,285,714
|
4,286
|
-
|
-
|
2,164,127
|
-
|
-
|
-
|
2,168,413
|
|||||||||||||||||||||||
Costs
related to issuance of common stock, May 1997
|
-
|
-
|
-
|
-
|
-
|
-
|
(108,421
|
)
|
-
|
-
|
-
|
(108,421
|
)
|
|||||||||||||||||||||
Issuance
of common stock for cash, May 1997, $10.1194
|
-
|
-
|
18,214
|
18
|
-
|
-
|
184,297
|
-
|
-
|
-
|
184,315
|
|||||||||||||||||||||||
Issuance
of common stock for cash, June 1997, $.0504
|
-
|
-
|
10,714
|
11
|
-
|
-
|
529
|
-
|
-
|
-
|
540
|
|||||||||||||||||||||||
Issuance
of common stock for cash, June 1997, $.5047
|
-
|
-
|
32,143
|
32
|
-
|
-
|
16,190
|
-
|
-
|
-
|
16,222
|
|||||||||||||||||||||||
Issuance
of common stock for cash, June 1997, $8.9810
|
-
|
-
|
29,579
|
30
|
-
|
-
|
265,618
|
-
|
-
|
-
|
265,648
|
|||||||||||||||||||||||
Issuance
of common stock for cash, June 1997, $10.0978
|
-
|
-
|
714
|
1
|
-
|
-
|
7,209
|
-
|
-
|
-
|
7,210
|
|||||||||||||||||||||||
Issuance
of common stock for cash, July 1997, $10.1214
|
-
|
-
|
25,993
|
26
|
-
|
-
|
263,060
|
-
|
-
|
-
|
263,086
|
|||||||||||||||||||||||
Costs
related to issuance of common stock
|
-
|
-
|
-
|
-
|
-
|
-
|
(26,960
|
)
|
-
|
-
|
-
|
(26,960
|
)
|
|||||||||||||||||||||
Founders
Shares transferred for services rendered
|
-
|
-
|
-
|
-
|
-
|
-
|
23,481
|
-
|
-
|
-
|
23,481
|
|||||||||||||||||||||||
Comprehensive
Income (Loss): Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(1,379,024
|
)
|
-
|
(1,379,024
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss) Currency translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
3,543
|
3,543
|
|||||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(1,379,024
|
)
|
3,543
|
(1,375,481
|
)
|
|||||||||||||||||||||||||||||
Balance,
July 31, 1997
|
-
|
$
|
-
|
9,000,118
|
$
|
9,000
|
-
|
$
|
-
|
$
|
5,512,782
|
$
|
-
|
$
|
(2,072,472
|
)
|
$
|
(474
|
)
|
$
|
3,448,836
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-7
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
SVR
Preferred Stock
|
|
Common
Stock
|
|
Treasury
Stock
|
|
Additional
Paid-In
|
|
Notes
Receivable - Common
|
|
Deficit
Accumulated During the Development
|
|
Accumulated
Other Comprehensive
|
|
Total
Stockholders’
|
|
|||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Stock
|
|
Stage
|
|
Income
(Loss)
|
|
Equity
|
||||||||||||
Balance,
August 1, 1997
|
-
|
$
|
-
|
9,000,118
|
$
|
9,000
|
-
|
$
|
-
|
$
|
5,512,782
|
$
|
-
|
$
|
(2,072,472
|
)
|
$
|
(474
|
)
|
$
|
3,448,836
|
|||||||||||||
Issuance
of warrants in exchange for services rendered, October 1997,
$.50
|
-
|
-
|
-
|
-
|
-
|
-
|
234,000
|
-
|
-
|
-
|
234,000
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, December 1997,
$0.05
|
-
|
-
|
234,000
|
234
|
-
|
-
|
10,698
|
-
|
-
|
-
|
10,932
|
|||||||||||||||||||||||
Issuance
of SVR Preferred Stock in exchange for services rendered, January
1998,
$.001
|
1,000
|
1
|
-
|
-
|
-
|
-
|
99
|
-
|
-
|
-
|
100
|
|||||||||||||||||||||||
Shares
issued pursuant to the January 9, 1998 reverse merger between
GBC-Delaware, Inc. and Generex Biotechnology Corporation
|
-
|
-
|
1,105,000
|
1,105
|
-
|
-
|
(1,105
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||
Issuance
of common stock for cash, March 1998, $2.50
|
-
|
-
|
70,753
|
71
|
-
|
-
|
176,812
|
-
|
-
|
-
|
176,883
|
|||||||||||||||||||||||
Issuance
of common stock for cash, April 1998, $2.50
|
-
|
-
|
60,000
|
60
|
-
|
-
|
149,940
|
-
|
-
|
-
|
150,000
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, April 1998,
$2.50
|
-
|
-
|
38,172
|
38
|
-
|
-
|
95,392
|
-
|
-
|
-
|
95,430
|
|||||||||||||||||||||||
Issuance
of common stock for cash, May 1998, $2.50
|
-
|
-
|
756,500
|
757
|
-
|
-
|
1,890,493
|
-
|
-
|
-
|
1,891,250
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, May 1998,
$2.50
|
-
|
-
|
162,000
|
162
|
-
|
-
|
404,838
|
-
|
-
|
-
|
405,000
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered, May 1998, $.60
|
-
|
-
|
-
|
-
|
-
|
-
|
300,000
|
-
|
-
|
-
|
300,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, June 1998, $2.50
|
-
|
-
|
286,000
|
286
|
-
|
-
|
714,714
|
-
|
-
|
-
|
715,000
|
|||||||||||||||||||||||
Exercise
of warrants for cash, June 1998, $0.0667
|
-
|
-
|
234,000
|
234
|
-
|
-
|
15,374
|
-
|
-
|
-
|
15,608
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, June 1998,
$2.50
|
-
|
-
|
24,729
|
24
|
-
|
-
|
61,799
|
-
|
-
|
-
|
61,823
|
|||||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(4,663,604
|
)
|
-
|
(4,663,604
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss)
|
||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(198,959
|
)
|
(198,959
|
)
|
|||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(4,663,604
|
)
|
(198,959
|
)
|
4,862,563
|
)
|
||||||||||||||||||||||||||||
Balance,
July 31, 1998
|
|
1,000
|
$
|
1
|
|
11,971,272
|
$
|
11,971
|
|
-
|
$
|
-
|
$
|
9,565,836
|
$
|
-
|
|
$
|
(6,736,076
|
)
|
$
|
(199,433
|
)
|
$
|
2,642,299
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-8
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
|
SVR
Preferred Stock
|
|
Common
Stock
|
|
Treasury
Stock
|
|
Additional
Paid-In
|
|
Notes
Receivable - Common
|
|
Deficit
Accumulated During the Development
|
|
Accumulated
Other Comprehensive
|
|
Total
Stockholders’
|
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Stock
|
|
Stage
|
|
Income
(Loss)
|
|
Equity
|
||||||||||||
Balance,
August 1, 1998
|
1,000
|
$
|
1
|
11,971,272
|
$
|
11,971
|
-
|
$
|
-
|
$
|
9,565,836
|
$
|
-
|
$
|
(6,736,076
|
)
|
$
|
(199,433
|
)
|
$
|
2,642,299
|
|||||||||||||
Issuance
of common stock for cash, August 1998, $3.00
|
-
|
-
|
100,000
|
100
|
-
|
-
|
299,900
|
-
|
-
|
-
|
300,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, August 1998, $3.50
|
-
|
-
|
19,482
|
19
|
-
|
-
|
68,168
|
-
|
-
|
-
|
68,187
|
|||||||||||||||||||||||
Redemption
of common stock for cash, September 1998, $7.75
|
-
|
-
|
(15,357
|
)
|
(15
|
)
|
-
|
-
|
(119,051
|
)
|
-
|
-
|
-
|
(119,066
|
)
|
|||||||||||||||||||
Issuance
of common stock for cash, September - October 1998, $3.00
|
-
|
-
|
220,297
|
220
|
-
|
-
|
660,671
|
-
|
-
|
-
|
660,891
|
|||||||||||||||||||||||
Issuance
of common stock for cash, August - October 1998, $4.10
|
-
|
-
|
210,818
|
211
|
-
|
-
|
864,142
|
-
|
-
|
-
|
864,353
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, August - October
1998,
$2.50
|
-
|
-
|
21,439
|
21
|
-
|
-
|
53,577
|
-
|
-
|
-
|
53,598
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, August - October
1998,
$4.10
|
-
|
-
|
18,065
|
18
|
-
|
-
|
74,048
|
-
|
-
|
-
|
74,066
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, September
1998, $4.10
|
-
|
-
|
180,000
|
180
|
-
|
-
|
737,820
|
-
|
-
|
-
|
738,000
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered, October 1998,
$.26
|
-
|
-
|
-
|
-
|
-
|
-
|
2,064
|
-
|
-
|
-
|
2,064
|
|||||||||||||||||||||||
Issuance
of stock options in exchange for services rendered, November
1998, $1.85
|
-
|
-
|
-
|
-
|
-
|
-
|
92,500
|
-
|
-
|
-
|
92,500
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered, November 1998,
$1.64
|
-
|
-
|
-
|
-
|
-
|
-
|
246,000
|
-
|
-
|
-
|
246,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, November 1998 - January 1999, $3.50
|
-
|
-
|
180,000
|
180
|
-
|
-
|
629,820
|
-
|
-
|
-
|
630,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, November 1998 - January 1999, $4.00
|
-
|
-
|
275,000
|
275
|
-
|
-
|
1,099,725
|
-
|
-
|
-
|
1,100,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, November 1998 - January 1999, $4.10
|
-
|
-
|
96,852
|
97
|
-
|
-
|
397,003
|
-
|
-
|
-
|
397,100
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, November 1998
- January
1999, $4.10
|
-
|
-
|
28,718
|
29
|
-
|
-
|
117,715
|
-
|
-
|
-
|
117,744
|
|||||||||||||||||||||||
Issuance
of common stock for cash, November 1998 - January 1999, $5.00
|
-
|
-
|
20,000
|
20
|
-
|
-
|
99,980
|
-
|
-
|
-
|
100,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, November 1998 - January 1999, $5.50
|
-
|
-
|
15,000
|
15
|
-
|
-
|
82,485
|
-
|
-
|
-
|
82,500
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, January 1999,
$5.00
|
-
|
-
|
392
|
-
|
-
|
-
|
1,960
|
-
|
-
|
-
|
1,960
|
|||||||||||||||||||||||
Issuance
of common stock for cash, February 1999, $5.00
|
-
|
-
|
6,000
|
6
|
-
|
-
|
29,994
|
-
|
-
|
-
|
30,000
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, February 1999,
$6.00
|
-
|
-
|
5,000
|
5
|
-
|
-
|
29,995
|
-
|
-
|
-
|
30,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, March 1999, $6.00
|
-
|
-
|
11,000
|
11
|
-
|
-
|
65,989
|
-
|
-
|
-
|
66,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash, April 1999, $5.50
|
-
|
-
|
363,637
|
364
|
-
|
-
|
1,999,640
|
-
|
-
|
-
|
2,000,004
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered, April 1999, $3.21
|
-
|
-
|
-
|
-
|
-
|
-
|
160,500
|
-
|
-
|
-
|
160,500
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered, April 1999, $3.17
|
-
|
-
|
-
|
-
|
-
|
-
|
317,000
|
-
|
-
|
-
|
317,000
|
F-9
Issuance
of warrants in exchange for services rendered, April 1999,
$2.89
|
-
|
-
|
-
|
-
|
-
|
-
|
144,500
|
-
|
-
|
-
|
144,500
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered, April 1999,
$3.27
|
-
|
-
|
-
|
-
|
184,310
|
-
|
-
|
-
|
184,310
|
|||||||||||||||||||||||||
Stock
adjustment
|
- |
-
|
714
|
1
|
-
|
-
|
(1
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||
Issuance
of common stock for cash, May 1999, $5.50
|
-
|
-
|
272,728
|
273
|
-
|
-
|
1,499,731
|
-
|
-
|
-
|
1,500,004
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for services rendered, May - June
1999, $5.50
|
-
|
-
|
60,874
|
61
|
-
|
-
|
334,746
|
-
|
334,807
|
|||||||||||||||||||||||||
Exercise
of warrants for cash, June 1999, $5.50 -
|
-
|
-
|
388,375
|
389
|
-
|
-
|
1,941,484
|
-
|
-
|
-
|
1,941,873
|
|||||||||||||||||||||||
Exercise
of warrants in exchange for note receivable, June 1999, $5.00
|
-
|
-
|
94,776
|
95
|
-
|
-
|
473,787
|
(473,882
|
)
|
-
|
-
|
-
|
||||||||||||||||||||||
Exercise
of warrants in exchange for services rendered, June 1999, $5.00
|
-
|
-
|
13,396
|
13
|
-
|
-
|
66,967
|
-
|
-
|
-
|
66,980
|
|||||||||||||||||||||||
Reduction
of note receivable in exchange for services rendered
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
38,979
|
-
|
-
|
38,979
|
|||||||||||||||||||||||
Shares
tendered in conjunction with warrant exercise, June 1999, $7.8125
|
-
|
-
|
(323,920
|
)
|
(324
|
)
|
-
|
-
|
(2,530,301
|
)
|
-
|
-
|
-
|
(2,530,625
|
)
|
|||||||||||||||||||
Exercise
of warrants for shares tendered, June 1999, $5.00
|
-
|
-
|
506,125
|
506
|
-
|
-
|
2,530,119
|
-
|
-
|
-
|
2,530,625
|
|||||||||||||||||||||||
Cost
of warrants redeemed for cash
|
-
|
-
|
-
|
-
|
-
|
(3,769
|
)
|
-
|
-
|
-
|
(3,769
|
)
|
||||||||||||||||||||||
Cost
related to warrant redemption, June 1999
|
-
|
-
|
-
|
-
|
-
|
-
|
(135,431
|
)
|
-
|
-
|
-
|
(135,431
|
)
|
|||||||||||||||||||||
Costs
related to issuance of common stock
|
- |
-
|
-
|
-
|
-
|
-
|
(1,179,895
|
)
|
-
|
-
|
-
|
(1,179,895
|
)
|
|||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(6,239,602
|
)
|
-
|
(6,239,602
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss):
|
||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1,393
|
1,393
|
|||||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(6,239,602
|
)
|
1,393
|
(6,238,209
|
)
|
|||||||||||||||||||||||||||||
Balance,
July 31, 1999
|
1,000
|
$
|
1
|
14,740,683
|
$
|
14,741
|
-
|
$
|
-
|
$
|
20,903,728
|
$
|
(434,903
|
)
|
$
|
(12,975,678
|
)
|
$
|
(198,040
|
)
|
$
|
7,309,849
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-10
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
SVR
Preferred Stock
|
|
Common
Stock
|
|
Treasury
Stock
|
|
Additional
Paid-In
|
|
Notes
Receivable - Common
|
|
Deficit
Accumulated During the Development
|
|
Accumulated
Other Comprehensive
|
|
Total
Stockholders’
|
|
|||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Stock
|
|
Stage
|
|
Income
(Loss)
|
|
Equity
|
||||||||||||
Balance,
August 1, 1999
|
1,000
|
$
|
1
|
14,740,683
|
$
|
14,741
|
-
|
$
|
-
|
$
|
20,903,728
|
$
|
(434,903
|
)
|
$
|
(12,975,678
|
)
|
$
|
(198,040
|
)
|
$
|
7,309,849
|
||||||||||||
Adjustment
for exercise of warrants recorded June 1999, $5.00
|
-
|
-
|
(2,300
|
)
|
(2
|
)
|
-
|
-
|
2
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||
Issuance
of common stock for cash, September 1999, $6.00
|
-
|
-
|
2,500
|
2
|
-
|
-
|
14,998
|
-
|
-
|
-
|
15,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, January
2000,
$4.25
|
-
|
-
|
470,590
|
471
|
-
|
-
|
1,999,537
|
-
|
-
|
-
|
2,000,008
|
|||||||||||||||||||||||
Financing
costs associated with private placement, January, 2000
|
-
|
-
|
-
|
-
|
-
|
-
|
(220,192
|
)
|
-
|
-
|
-
|
(220,192
|
)
|
|||||||||||||||||||||
Issuance
of stock in exchange for services rendered, January 2000, $5.00
|
-
|
-
|
8,100
|
8
|
-
|
-
|
40,492
|
-
|
-
|
-
|
40,500
|
|||||||||||||||||||||||
Granting
of stock options for services rendered, January 2000
|
-
|
-
|
-
|
-
|
-
|
-
|
568,850
|
-
|
-
|
-
|
568,850
|
|||||||||||||||||||||||
Granting
of warrants for services rendered, January 2000
|
-
|
-
|
-
|
-
|
-
|
-
|
355,500
|
-
|
-
|
-
|
355,500
|
|||||||||||||||||||||||
Exercise
of warrants for cash, February 2000, $5.50
|
-
|
-
|
2,000
|
2
|
-
|
-
|
10,998
|
-
|
-
|
-
|
11,000
|
|||||||||||||||||||||||
Exercise
of warrants for cash, March 2000, $5.50
|
-
|
-
|
29,091
|
29
|
-
|
-
|
159,972
|
-
|
-
|
-
|
160,001
|
|||||||||||||||||||||||
Exercise
of warrants for cash, March 2000, $6.00
|
-
|
-
|
2,000
|
2
|
-
|
-
|
11,998
|
-
|
-
|
-
|
12,000
|
|||||||||||||||||||||||
Exercise
of warrants for cash, March 2000, $7.50
|
-
|
-
|
8,000
|
8
|
-
|
-
|
59,992
|
-
|
-
|
-
|
60,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, June
2000, $6.00
|
-
|
-
|
1,041,669
|
1,042
|
-
|
-
|
6,248,972
|
-
|
-
|
-
|
6,250,014
|
|||||||||||||||||||||||
Financing
costs associated with private placement, June 2000
|
-
|
-
|
-
|
-
|
-
|
-
|
(385,607
|
)
|
-
|
-
|
-
|
(385,607
|
)
|
|||||||||||||||||||||
Issuance
of common stock for services, June 2000, $6.00
|
-
|
-
|
4,300
|
4
|
-
|
-
|
25,796
|
-
|
-
|
-
|
25,800
|
|||||||||||||||||||||||
Exercise
of warrants for cash, July 2000, $6.00
|
-
|
-
|
3,000
|
3
|
-
|
-
|
17,997
|
-
|
-
|
-
|
18,000
|
|||||||||||||||||||||||
Exercise
of warrants for cash, July 2000, $7.50
|
-
|
-
|
16,700
|
17
|
-
|
-
|
125,233
|
-
|
-
|
-
|
125,250
|
|||||||||||||||||||||||
Granting
of stock options for services rendered, July 2000
|
-
|
-
|
-
|
-
|
-
|
-
|
496,800
|
-
|
-
|
-
|
496,800
|
|||||||||||||||||||||||
Reduction
of note receivable in exchange for services rendered
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
384,903
|
-
|
-
|
384,903
|
|||||||||||||||||||||||
Accrued
interest on note receivable
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(4,118
|
)
|
-
|
-
|
(4,118
|
)
|
|||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(8,841,047
|
)
|
-
|
(8,841,047
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss):
|
||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
32,514
|
32,514
|
|||||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(8,841,047
|
)
|
32,514
|
(8,808,533
|
)
|
|||||||||||||||||||||||||||||
Balance,
July 31, 2000
|
1,000
|
$
|
1
|
16,326,333
|
$
|
16,327
|
-
|
$
|
-
|
$
|
30,435,066
|
$
|
(54,118
|
)
|
$
|
(21,816,725
|
)
|
$
|
(165,526
|
)
|
$
|
8,415,025
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-11
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS’
EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
Deficit
|
||||||||||||||||||||||||||||||||||
SVR
|
Notes
|
Accumulated
|
Accumulated
|
|||||||||||||||||||||||||||||||
Preferred
|
Common
|
Treasury
|
Additional
|
Receivable
|
During
the
|
Other
|
Total
|
|||||||||||||||||||||||||||
Stock
|
Stock
|
Stock
|
Paid-In
|
-
Common
|
Development
|
Comprehensive
|
Stockholders’
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Stage
|
Income
(Loss)
|
Equity
|
||||||||||||||||||||||||
Balance,
August 1, 2000
|
1,000
|
$
|
1
|
16,326,333
|
$
|
16,327
|
-
|
$
|
-
|
$
|
30,435,066
|
$
|
(54,118
|
)
|
$
|
(21,816,725
|
)
|
$
|
(165,526
|
)
|
$
|
8,415,025
|
||||||||||||
Exercise
of warrants for cash, August 2000, $6.00
|
-
|
-
|
2,000
|
2
|
-
|
-
|
11,998
|
-
|
-
|
-
|
12,000
|
|||||||||||||||||||||||
Issuance
of common stock for services rendered
|
||||||||||||||||||||||||||||||||||
August
2000
|
-
|
-
|
35,000
|
35
|
-
|
-
|
411,215
|
-
|
-
|
-
|
411,250
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for equity line
|
||||||||||||||||||||||||||||||||||
agreement,
August 2000
|
-
|
-
|
-
|
-
|
-
|
-
|
3,406,196
|
-
|
-
|
-
|
3,406,196
|
|||||||||||||||||||||||
Exercise
of warrants for cash, August 2000, $7.50
|
-
|
-
|
30,300
|
30
|
-
|
-
|
227,220
|
-
|
-
|
-
|
227,250
|
|||||||||||||||||||||||
Exercise
of warrants for cash, August 2000, $8.6625
|
-
|
-
|
30,000
|
30
|
-
|
-
|
259,845
|
-
|
-
|
-
|
259,875
|
|||||||||||||||||||||||
Cashless
exercise of warrants, August 2000
|
-
|
-
|
8,600
|
9
|
-
|
-
|
(9
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||
Exercise
of warrants for cash, August 2000, $10.00
|
-
|
-
|
10,000
|
10
|
-
|
-
|
99,990
|
-
|
-
|
-
|
100,000
|
|||||||||||||||||||||||
Exercise
of warrants for cash, September 2000, $8.6625
|
-
|
-
|
63,335
|
63
|
-
|
-
|
548,576
|
-
|
-
|
-
|
548,639
|
|||||||||||||||||||||||
Exercise
of warrants for cash, September 2000, $5.50
|
-
|
-
|
16,182
|
16
|
-
|
-
|
88,986
|
-
|
-
|
-
|
89,002
|
|||||||||||||||||||||||
Exercise
of warrants for cash, September 2000, $6.00
|
-
|
-
|
53,087
|
53
|
-
|
-
|
318,470
|
-
|
-
|
-
|
318,523
|
|||||||||||||||||||||||
Exercise
of warrants for cash, September 2000, $10.00
|
-
|
-
|
9,584
|
10
|
-
|
-
|
95,830
|
-
|
-
|
-
|
95,840
|
|||||||||||||||||||||||
Exercise
of warrants for cash, September 2000, $7.50
|
-
|
-
|
32,416
|
32
|
-
|
-
|
243,088
|
-
|
-
|
-
|
243,120
|
|||||||||||||||||||||||
Issuance
of common stock for
cash
pursuant to
|
||||||||||||||||||||||||||||||||||
private
placement,
October
2000, $11.00
|
-
|
-
|
2,151,093
|
2,151
|
-
|
-
|
23,659,872
|
-
|
-
|
-
|
23,662,023
|
|||||||||||||||||||||||
Exercise
of warrants for cash, Oct. 2000, $6.00
|
-
|
-
|
1,000
|
1
|
-
|
-
|
5,999
|
-
|
-
|
-
|
6,000
|
|||||||||||||||||||||||
Financing
costs associated
with
private placement,
|
||||||||||||||||||||||||||||||||||
October
2000
|
-
|
-
|
-
|
-
|
-
|
-
|
(1,956,340
|
)
|
-
|
-
|
-
|
(1,956,340
|
)
|
|||||||||||||||||||||
Exercise
of warrants for
cash,
November -
December
|
||||||||||||||||||||||||||||||||||
2000,
$4.25
|
-
|
-
|
23,528
|
23
|
-
|
-
|
99,971
|
-
|
-
|
-
|
99,994
|
|||||||||||||||||||||||
Cashless
exercise of warrants, December 2000
|
-
|
-
|
3,118
|
3
|
-
|
-
|
(3
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||
Exercise
of warrants for cash,
November
- December
|
||||||||||||||||||||||||||||||||||
2000,
$6.00
|
-
|
-
|
22,913
|
23
|
-
|
-
|
137,455
|
-
|
-
|
-
|
137,478
|
|||||||||||||||||||||||
Exercise
of warrants for cash, December 2000, $7.00
|
-
|
-
|
8,823
|
9
|
-
|
-
|
61,752
|
-
|
-
|
-
|
61,761
|
|||||||||||||||||||||||
Issuance
of common stock as
employee
|
||||||||||||||||||||||||||||||||||
compensation,
December 2000
|
-
|
-
|
8,650
|
8
|
-
|
-
|
100,548
|
-
|
-
|
-
|
100,556
|
|||||||||||||||||||||||
Exercise
of warrants for cash, January 2001, $6.00
|
-
|
-
|
3,000
|
3
|
-
|
-
|
17,997
|
-
|
-
|
-
|
18,000
|
|||||||||||||||||||||||
Issuance
of common stock for
cash
pursuant to
|
||||||||||||||||||||||||||||||||||
private
placement, January 2001, $14.53
|
-
|
-
|
344,116
|
344
|
-
|
-
|
4,999,656
|
-
|
-
|
-
|
5,000,000
|
|||||||||||||||||||||||
Financing
costs associated
with
private placement,
|
||||||||||||||||||||||||||||||||||
January
2001
|
-
|
-
|
-
|
-
|
-
|
-
|
(200,000
|
)
|
-
|
-
|
-
|
(200,000
|
)
|
|||||||||||||||||||||
Issuance
of common stock
pursuant
to litigation
|
||||||||||||||||||||||||||||||||||
settlement,
January 2001
|
-
|
-
|
2,832
|
2
|
-
|
-
|
21,096
|
-
|
-
|
-
|
21,098
|
|||||||||||||||||||||||
Granting
of stock options in
exchange
for services
|
||||||||||||||||||||||||||||||||||
rendered,
January 2001
|
-
|
-
|
-
|
-
|
-
|
-
|
745,000
|
-
|
-
|
-
|
745,000
|
|||||||||||||||||||||||
Granting
of stock options in
exchange
for services
|
||||||||||||||||||||||||||||||||||
rendered,
February 2001
|
-
|
-
|
-
|
-
|
-
|
-
|
129,600
|
-
|
-
|
-
|
129,600
|
|||||||||||||||||||||||
Exercise
of stock options
for
cash,
|
||||||||||||||||||||||||||||||||||
February
2001, $5.00
|
-
|
-
|
50,000
|
50
|
-
|
-
|
249,950
|
-
|
-
|
-
|
250,000
|
|||||||||||||||||||||||
Exercise
of warrants for cash,
March
2001, $6.00
|
-
|
-
|
500
|
1
|
-
|
-
|
2,999
|
-
|
-
|
-
|
3,000
|
|||||||||||||||||||||||
Exercise
of stock options in
exchange
for note
|
||||||||||||||||||||||||||||||||||
receivable,
March 2001
|
-
|
-
|
50,000
|
50
|
-
|
-
|
249,950
|
(250,000
|
)
|
-
|
-
|
-
|
||||||||||||||||||||||
Issuance
of common stock in
exchange
for services
|
||||||||||||||||||||||||||||||||||
rendered,
March 2001, $5.50
|
-
|
-
|
8,000
|
8
|
-
|
-
|
43,992
|
-
|
-
|
-
|
44,000
|
|||||||||||||||||||||||
Granting
of stock options in
exchange
for services
|
||||||||||||||||||||||||||||||||||
rendered,
May 2001
|
-
|
-
|
-
|
-
|
-
|
-
|
592,300
|
-
|
-
|
-
|
592,300
|
|||||||||||||||||||||||
Exercise
of stock options for cash, June 2001, $5.00
|
-
|
-
|
75,000
|
75
|
-
|
-
|
374,925
|
-
|
-
|
-
|
375,000
|
F-12
Exercise
of stock options for cash, June 2001, $5.50
|
-
|
-
|
12,500
|
12
|
-
|
-
|
68,738
|
-
|
-
|
-
|
68,750
|
|||||||||||||||||||||||
Exercise
of warrants for cash, June 2001, $6.00
|
-
|
-
|
4,000
|
4
|
-
|
-
|
23,996
|
-
|
-
|
-
|
24,000
|
|||||||||||||||||||||||
Exercise
of stock options for cash, July 2001, $5.00
|
-
|
-
|
7,500
|
8
|
-
|
-
|
37,492
|
-
|
-
|
-
|
37,500
|
|||||||||||||||||||||||
Exercise
of stock options for cash, July 2001, $5.50
|
-
|
-
|
2,500
|
3
|
-
|
-
|
13,747
|
-
|
-
|
-
|
13,750
|
|||||||||||||||||||||||
Exercise
of warrants for cash, July 2001, $6.00
|
-
|
-
|
2,000
|
2
|
-
|
-
|
11,998
|
-
|
-
|
-
|
12,000
|
|||||||||||||||||||||||
Issuance
of common stock for
cash
pursuant to
|
||||||||||||||||||||||||||||||||||
private
placement, July 2001, $9.25
|
-
|
-
|
1,254,053
|
1,254
|
-
|
-
|
11,598,736
|
-
|
-
|
-
|
11,599,990
|
|||||||||||||||||||||||
Financing
costs associated
with
private placement,
|
||||||||||||||||||||||||||||||||||
July
2001
|
-
|
-
|
-
|
-
|
-
|
-
|
(768,599
|
)
|
-
|
-
|
-
|
(768,599
|
)
|
|||||||||||||||||||||
Shares
issued in exchange for
services
rendered,
|
||||||||||||||||||||||||||||||||||
July
2001, $9.25
|
-
|
-
|
23,784
|
24
|
-
|
-
|
219,978
|
-
|
-
|
-
|
220,002
|
|||||||||||||||||||||||
Shares
issued for Anti-Dilution
Provisions,
July 2001
|
-
|
-
|
5,779
|
6
|
-
|
-
|
53,450
|
-
|
-
|
-
|
53,456
|
|||||||||||||||||||||||
Issuance
of warrants in
exchange
for services rendered,
|
||||||||||||||||||||||||||||||||||
July
2001
|
-
|
-
|
-
|
-
|
-
|
-
|
19,134
|
-
|
-
|
-
|
19,134
|
|||||||||||||||||||||||
Accrued
interest on note receivable
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(10,182
|
)
|
-
|
-
|
(10,182
|
)
|
|||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(27,097,210
|
)
|
-
|
(27,097,210
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss):
|
||||||||||||||||||||||||||||||||||
Currency
translation
adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(81,341
|
)
|
(81,341
|
)
|
|||||||||||||||||||||
Total
Comprehensive
Income
(Loss)
|
|
(27,097,210
|
)
|
(81,341
|
)
|
(27,178,551
|
)
|
|||||||||||||||||||||||||||
Balance
at July 31, 2001
|
1,000
|
$
|
1
|
20,681,526
|
$
|
20,681
|
-
|
$
|
-
|
$
|
76,761,860
|
$
|
(314,300
|
)
|
$
|
(48,913,935
|
)
|
$
|
(246,867
|
)
|
$
|
27,307,440
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-13
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
Deficit
|
||||||||||||||||||||||||||||||||||
SVR
|
Notes
|
Accumulated
|
Accumulated
|
|||||||||||||||||||||||||||||||
Preferred
|
Common
|
Treasury
|
Additional
|
Receivable
|
During
the
|
Other
|
Total
|
|||||||||||||||||||||||||||
Stock
|
Stock
|
Stock
|
Paid-In
|
-
Common
|
Development
|
Comprehensive
|
Stockholders’
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Stage
|
Income
(Loss)
|
Equity
|
||||||||||||||||||||||||
Balance,
August 1, 2001
|
1,000
|
$
|
1
|
20,681,526
|
$
|
20,681
|
-
|
$
|
-
|
$
|
76,761,860
|
$
|
(314,300
|
)
|
$
|
(48,913,935
|
)
|
$
|
(246,867
|
)
|
$
|
27,307,440
|
||||||||||||
Exercise
of stock options for cash,
|
||||||||||||||||||||||||||||||||||
August
2001, $5.50
|
-
|
-
|
5,000
|
5
|
-
|
-
|
27,495
|
-
|
-
|
-
|
27,500
|
|||||||||||||||||||||||
Purchase
of Treasury Stock
for
cash
|
||||||||||||||||||||||||||||||||||
October
2001, $3.915
|
-
|
-
|
-
|
-
|
(10,000
|
)
|
(39,150
|
)
|
-
|
-
|
-
|
-
|
(39,150
|
)
|
||||||||||||||||||||
Issuance
of stock options in
exchange
for services
|
||||||||||||||||||||||||||||||||||
rendered,
December 2001
|
-
|
-
|
-
|
-
|
-
|
-
|
25,000
|
-
|
-
|
-
|
25,000
|
|||||||||||||||||||||||
Issuance
of common stock as
employee
|
||||||||||||||||||||||||||||||||||
compensation,
January 2002
|
-
|
-
|
10,800
|
11
|
-
|
-
|
71,161
|
-
|
-
|
-
|
71,172
|
|||||||||||||||||||||||
Preferred
stock dividend paid
January
2002
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(720,900
|
)
|
-
|
(720,900
|
)
|
|||||||||||||||||||||
Purchase
of Treasury Stock
for
cash
|
||||||||||||||||||||||||||||||||||
February
2002, $4.693
|
-
|
-
|
-
|
-
|
(31,400
|
)
|
(147,346
|
)
|
-
|
-
|
-
|
-
|
(147,346
|
)
|
||||||||||||||||||||
Issuance
of warrants in exchange
for
services
|
||||||||||||||||||||||||||||||||||
rendered,
March 2002
|
-
|
-
|
-
|
-
|
-
|
-
|
202,328
|
-
|
-
|
-
|
202,328
|
|||||||||||||||||||||||
Purchase
of Treasury Stock
for
cash
|
||||||||||||||||||||||||||||||||||
March
2002, $4.911
|
-
|
-
|
-
|
-
|
(7,700
|
)
|
(37,816
|
)
|
-
|
-
|
-
|
-
|
(37,816
|
)
|
||||||||||||||||||||
Purchase
of Treasury Stock
for
cash
|
||||||||||||||||||||||||||||||||||
April
2002, $4.025
|
-
|
-
|
-
|
-
|
(12,800
|
)
|
(54,516
|
)
|
-
|
-
|
-
|
-
|
(54,516
|
)
|
||||||||||||||||||||
Issuance
of stock options in
exchange
for
|
||||||||||||||||||||||||||||||||||
services
rendered, June 2002
|
-
|
-
|
-
|
-
|
-
|
-
|
132,387
|
-
|
-
|
-
|
132,387
|
|||||||||||||||||||||||
Purchase
of Treasury Stock for
cash
|
-
|
|||||||||||||||||||||||||||||||||
July
2002, $4.025
|
-
|
-
|
-
|
-
|
(34,600
|
)
|
(116,703
|
)
|
-
|
-
|
-
|
-
|
(116,703
|
)
|
||||||||||||||||||||
Accrued
interest on note receivable
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(22,585
|
)
|
-
|
-
|
(22,585
|
)
|
|||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(13,693,034
|
)
|
-
|
(13,693,034
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss):
|
||||||||||||||||||||||||||||||||||
Currency
translation
adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(71,185
|
)
|
(71,185
|
)
|
|||||||||||||||||||||
Total
Comprehensive
Income
(Loss)
|
|
(13,693,034
|
)
|
(71,185
|
)
|
(13,764,219
|
)
|
|||||||||||||||||||||||||||
Balance
at July 31, 2002
|
1,000
|
$
|
1
|
20,697,326
|
$
|
20,697
|
(96,500
|
)
|
$
|
(395,531
|
)
|
$
|
77,220,231
|
$
|
(336,885
|
)
|
$
|
(63,327,869
|
)
|
$
|
(318,052
|
)
|
$
|
12,862,592
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-14
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
(A
DEVELOPMENT STAGE COMPANY)
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
|
|
|
|
|
|
|
|
Notes
|
Deficit
|
|
|
|||||||||||||||||||||||
|
SVR
|
|
|
|
|
Receivable
|
Accumulated
|
Accumulated
|
|
|||||||||||||||||||||||||
|
Preferred
|
Common
|
Treasury
|
Additional
|
-
|
During
the
|
Other
|
Total
|
||||||||||||||||||||||||||
|
Stock
|
Stock
|
Stock
|
Paid-In
|
Common
|
Development
|
Comprehensive
|
Stockholders’
|
||||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Stage
|
Income
(Loss)
|
Equity
|
|||||||||||||||||||||||
Balance,
August 1, 2002
|
1,000
|
$
|
1
|
20,697,326
|
$
|
20,697
|
(96,500
|
)
|
$
|
(395,531
|
)
|
$
|
77,220,231
|
$
|
(336,885
|
)
|
$
|
(63,327,869
|
)
|
$
|
(318,052
|
)
|
$
|
12,862,592
|
||||||||||
Receipt
of restricted shares of
common
stock as
|
||||||||||||||||||||||||||||||||||
settlement
for executive loan,
September
2002, $1.90
|
-
|
-
|
-
|
-
|
(592,716
|
)
|
(1,126,157
|
)
|
-
|
-
|
-
|
-
|
(1,126,157
|
)
|
||||||||||||||||||||
Purchase
of Treasury Stock
for
cash
|
||||||||||||||||||||||||||||||||||
October
2002, $1.5574
|
-
|
-
|
-
|
-
|
(40,000
|
)
|
(62,294
|
)
|
-
|
-
|
-
|
-
|
(62,294
|
)
|
||||||||||||||||||||
Issuance
of warrants in
exchange
for the services
|
||||||||||||||||||||||||||||||||||
rendered,
November
2002,
$2.50
|
-
|
-
|
-
|
-
|
-
|
-
|
988,550
|
-
|
-
|
-
|
988,550
|
|||||||||||||||||||||||
Issuance
of stock options in
exchange
for services
|
||||||||||||||||||||||||||||||||||
receivable,
November
2002,
$2.10
|
-
|
-
|
-
|
-
|
-
|
-
|
171,360
|
-
|
-
|
-
|
171,360
|
|||||||||||||||||||||||
Issuance
of common stock
in
exchange for services
|
||||||||||||||||||||||||||||||||||
rendered,
November
2002,
$2.10
|
-
|
-
|
30,000
|
30
|
-
|
-
|
62,970
|
-
|
-
|
-
|
63,000
|
|||||||||||||||||||||||
Issuance
of common stock
as
employee compensation,
|
||||||||||||||||||||||||||||||||||
January
2003, $2.10
|
-
|
-
|
9,750
|
10
|
-
|
-
|
20,465
|
-
|
-
|
-
|
20,475
|
|||||||||||||||||||||||
Purchase
of Treasury Stock
for
cash December 2002,
|
||||||||||||||||||||||||||||||||||
$2.0034
|
-
|
-
|
-
|
-
|
(13,000
|
)
|
(26,044
|
)
|
-
|
-
|
-
|
-
|
(26,044
|
)
|
||||||||||||||||||||
Preferred
stock dividend paid
January
2003
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(764,154
|
)
|
-
|
(764,154
|
)
|
|||||||||||||||||||||
Issuance
of common stock in
exchange
for services
|
||||||||||||||||||||||||||||||||||
rendered,
March 2003, $1.00
|
-
|
-
|
70,000
|
70
|
-
|
-
|
69,930
|
-
|
-
|
-
|
70,000
|
|||||||||||||||||||||||
Issuance
of common stock
for
cash pursuant to
|
||||||||||||||||||||||||||||||||||
private
placement,
May
2003, $1.15
|
-
|
-
|
2,926,301
|
2,926
|
-
|
-
|
3,362,324
|
-
|
-
|
-
|
3,365,250
|
|||||||||||||||||||||||
Financing
costs associated
with
private placement,
|
||||||||||||||||||||||||||||||||||
May
2003
|
-
|
-
|
-
|
-
|
-
|
-
|
(235,568
|
)
|
-
|
-
|
-
|
(235,568
|
)
|
|||||||||||||||||||||
Exercise
of warrants for cash,
May
2003, $1.50
|
-
|
-
|
35,000
|
35
|
-
|
-
|
52,465
|
-
|
-
|
-
|
52,500
|
|||||||||||||||||||||||
Issuance
of common stock for
cash
pursuant to
|
||||||||||||||||||||||||||||||||||
private
placement,
June
2003, $1.50
|
-
|
-
|
666,667
|
667
|
-
|
-
|
999,333
|
-
|
-
|
-
|
1,000,000
|
|||||||||||||||||||||||
Issuance
of common stock
as
employee compensation,
|
||||||||||||||||||||||||||||||||||
June
2003, $2.00
|
-
|
-
|
100
|
-
|
-
|
-
|
200
|
-
|
-
|
-
|
200
|
|||||||||||||||||||||||
Exercise
of warrants for cash,
June
2003, $1.50
|
-
|
-
|
1,496,001
|
1,496
|
-
|
-
|
2,242,506
|
-
|
-
|
-
|
2,244,002
|
|||||||||||||||||||||||
Cashless
exercise of warrants,
June
2003
|
-
|
-
|
16,379
|
16
|
-
|
-
|
(16
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||
Exercise
of stock options for
cash,
June 2003, $1.59
|
-
|
-
|
70,000
|
70
|
-
|
-
|
111,230
|
-
|
-
|
-
|
111,300
|
|||||||||||||||||||||||
Accrued
interest on note
receivable
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(23,113
|
)
|
-
|
-
|
(23,113
|
)
|
|||||||||||||||||||||
Comprehensive
Income
(Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(13,261,764
|
)
|
-
|
(13,261,764
|
)
|
|||||||||||||||||||||
Other
comprehensive
income
(loss)
|
||||||||||||||||||||||||||||||||||
Currency
translation
adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
406,830
|
406,830
|
|||||||||||||||||||||||
Total
Comprehensive
Income
(Loss)
|
(13,261,764
|
)
|
406,830
|
(12,854,934
|
)
|
|||||||||||||||||||||||||||||
Balance
at July 31, 2003
|
1,000
|
$
|
1
|
26,017,524
|
$
|
26,017
|
(742,216
|
)
|
$
|
(1,610,026
|
)
|
$
|
85,065,980
|
$
|
(359,998
|
)
|
$
|
(77,353,787
|
)
|
$
|
88,778
|
$
|
5,856,965
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-15
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31,
2007
|
|
SVR
Preferred
Stock
|
|
Common
Stock
|
|
Treasury
Stock
|
|
Additional
Paid-In
|
|
Notes
Receivable
- Common
|
|
Deficit
Accumulated
During
the
Development
|
|
Accumulated
Other
Comprehensive
|
|
Total
Stockholders'
|
||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Stage
|
Income
(Loss)
|
Equity
|
|||||||||||||||||||||||
Balance,
August 1, 2003
|
1,000
|
$
|
1
|
26,017,524
|
$
|
26,017
|
(742,216
|
)
|
$
|
(1,610,026
|
)
|
$
|
85,065,980
|
$
|
(359,998
|
)
|
$
|
(77,353,787
|
)
|
$
|
88,778
|
$
|
5,856,965
|
|||||||||||
Shares
issued pursuant to acquisition of Antigen Express Inc., August
2003
|
-
|
-
|
2,779,974
|
2,780
|
-
|
-
|
4,639,777
|
-
|
-
|
-
|
4,642,557
|
|||||||||||||||||||||||
Cost
of stock options to be assumed in conjunction with merger
|
-
|
-
|
-
|
-
|
-
|
-
|
154,852
|
-
|
-
|
-
|
154,852
|
|||||||||||||||||||||||
Exercise
of stock options for cash, September 2003, $1.59
|
-
|
-
|
10,000
|
10
|
-
|
-
|
15,890
|
-
|
-
|
-
|
15,900
|
|||||||||||||||||||||||
Exercise
of stock options for cash, October 2003, $2.10
|
-
|
-
|
14,900
|
15
|
-
|
-
|
31,275
|
-
|
-
|
-
|
31,290
|
|||||||||||||||||||||||
Exercise
of stock options for cash, October 2003, $1.59
|
-
|
-
|
10,000
|
10
|
-
|
-
|
15,890
|
-
|
-
|
-
|
15,900
|
|||||||||||||||||||||||
Exercise
of stock options for cash, October 2003, $0.30
|
-
|
-
|
65,000
|
65
|
-
|
-
|
19,435
|
-
|
-
|
-
|
19,500
|
|||||||||||||||||||||||
Exercise
of stock options for cash, October 2003, $0.55
|
-
|
-
|
40,000
|
40
|
-
|
-
|
21,960
|
-
|
-
|
-
|
22,000
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, October 2003,
$1.98
|
-
|
-
|
150,000
|
150
|
-
|
-
|
296,850
|
-
|
-
|
-
|
297,000
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, October 2003,
$1.84
|
-
|
-
|
337,500
|
338
|
-
|
-
|
620,662
|
-
|
-
|
-
|
621,000
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for the services rendered October 2003
(at $1.35)
|
-
|
-
|
-
|
-
|
-
|
-
|
27,000
|
-
|
-
|
-
|
27,000
|
|||||||||||||||||||||||
Exercise
of stock options for cash, November 2003, $2.10
|
-
|
-
|
10,500
|
10
|
-
|
-
|
22,040
|
-
|
-
|
-
|
22,050
|
|||||||||||||||||||||||
Redemption
of Treasury Stock, November 2003, $2.17
|
-
|
-
|
(742,216
|
)
|
(742
|
)
|
742,216
|
1,610,026
|
(1,609,284
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||
Granting
of stock options in exchange for services, November 2003 (at
$1.71)
|
-
|
-
|
-
|
-
|
-
|
-
|
151,433
|
-
|
-
|
-
|
151,433
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, Jan 2004,
$1.47
|
-
|
-
|
1,700,680
|
1,701
|
-
|
-
|
2,498,299
|
-
|
-
|
-
|
2,500,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, Jan 2004,
$1.80
|
-
|
-
|
55,556
|
56
|
-
|
-
|
99,944
|
-
|
-
|
-
|
100,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, Jan 2004,
$1.75
|
-
|
-
|
228,572
|
229
|
-
|
-
|
399,771
|
-
|
-
|
-
|
400,000
|
|||||||||||||||||||||||
Financing
costs associated with private placement, January 2004
|
-
|
-
|
-
|
-
|
-
|
-
|
(68,012
|
)
|
-
|
-
|
-
|
(68,012
|
)
|
|||||||||||||||||||||
Preferred
Stock Dividend paid in January
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(810,003
|
)
|
-
|
(810,003
|
)
|
|||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, Feb 2004,
$1.60
|
-
|
-
|
93,750
|
94
|
-
|
-
|
149,906
|
-
|
-
|
-
|
150,000
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, Feb 2004,
$1.66
|
-
|
-
|
68,675
|
69
|
-
|
-
|
113,932
|
-
|
-
|
-
|
114,001
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, Feb 2004,
$1.50
|
-
|
-
|
666,667
|
667
|
-
|
-
|
999,334
|
-
|
-
|
-
|
1,000,001
|
|||||||||||||||||||||||
Issuance
of common stock as employee compensation, Feb 2004, $1.48
|
-
|
-
|
8,850
|
8
|
-
|
-
|
13,089
|
-
|
-
|
-
|
13,097
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Feb 2004,
$1.48
|
-
|
-
|
175,000
|
175
|
-
|
-
|
258,825
|
-
|
-
|
-
|
259,000
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Feb 2004,
$1.51
|
-
|
-
|
112,500
|
113
|
-
|
-
|
169,762
|
-
|
-
|
-
|
169,875
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, July
2004, $1.22
|
-
|
-
|
2,459,016
|
2,459
|
-
|
-
|
2,997,541
|
-
|
-
|
-
|
3,000,000
|
|||||||||||||||||||||||
Financing
costs associated with private placement, July 2004
|
-
|
-
|
-
|
-
|
-
|
-
|
(41,250
|
)
|
-
|
-
|
-
|
(41,250
|
)
|
|||||||||||||||||||||
Variable
accounting non-cash compensation expense
|
-
|
-
|
-
|
-
|
-
|
-
|
45,390
|
-
|
-
|
-
|
45,390
|
|||||||||||||||||||||||
Accrued
interest on note receivable
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(24,805
|
)
|
-
|
-
|
(24,805
|
)
|
|||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(18,362,583
|
)
|
-
|
(18,362,583
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss)
|
||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
207,593
|
207,593
|
|||||||||||||||||||||||
Total Comprehensive Income
(Loss)
|
(18,362,583
|
)
|
207,593
|
(18,154,990
|
)
|
|||||||||||||||||||||||||||||
Balance
at July 31, 2004
|
1,000
|
$
|
1
|
34,262,448
|
$
|
34,264
|
-
|
$
|
-
|
$
|
97,110,291
|
$
|
(384,803
|
)
|
$
|
(96,526,373
|
)
|
$
|
296,371
|
$
|
529,751
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-16
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31,
2007
|
|
SVR
Preferred Stock
|
|
Common
Stock
|
|
Treasury
Stock
|
|
Additional
Paid-In
|
|
Notes
Receivable - Common
|
|
Deficit
Accumulated During the Development
|
|
Accumulated
Other Comprehensive
|
Total
Stockholders’
|
|||||||||||||||||||
Shares
|
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Stage
|
Income
(Loss)
|
Equity
|
|||||||||||||||||||||||
Balance,
August 1, 2004
|
1,000
|
$
|
1
|
34,262,448
|
$
|
34,264
|
-
|
$
|
-
|
$
|
97,110,291
|
$
|
(384,803
|
)
|
$
|
(96,526,373
|
)
|
$
|
296,371
|
$
|
529,751
|
|||||||||||||
Issuance
of common stock In exchange for services rendered, Aug 2004,
$1.09
|
-
|
-
|
620,000
|
620
|
-
|
-
|
675,180
|
-
|
-
|
-
|
675,800
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered Aug 2004, $1.08
|
-
|
-
|
-
|
-
|
-
|
-
|
415,000
|
-
|
-
|
-
|
415,000
|
|||||||||||||||||||||||
Granting
of stock options in exchange for services, Oct 2004, $0.94
|
-
|
-
|
-
|
-
|
-
|
-
|
75,600
|
-
|
-
|
-
|
75,600
|
|||||||||||||||||||||||
Cancellation
of common stock for non-performance of services, Oct 2004,
$0.94
|
-
|
-
|
(75,000
|
)
|
(75
|
)
|
-
|
-
|
(137,925
|
)
|
-
|
-
|
-
|
(138,000
|
)
|
|||||||||||||||||||
Issuance
of warrants in conjunction with financing, Nov 2004, $0.91
|
-
|
-
|
-
|
-
|
-
|
-
|
89,900
|
-
|
-
|
-
|
89,900
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, $4,000,000,
Nov
2004 $0.91
|
-
|
-
|
-
|
-
|
-
|
-
|
1,722,222
|
-
|
-
|
-
|
1,722,222
|
|||||||||||||||||||||||
Value
of beneficial conversion feature on convertible debentures,
$4,000,000,
Nov 2004 $0.91
|
-
|
-
|
-
|
-
|
-
|
-
|
1,722,222
|
-
|
-
|
-
|
1,722,222
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Dec 2004,
$0.71
|
-
|
-
|
48,000
|
48
|
-
|
-
|
34,032
|
-
|
-
|
-
|
34,080
|
|||||||||||||||||||||||
Conversion
of Series A Preferred Stock, Dec 2004 $25.77
|
-
|
-
|
534,085
|
534
|
-
|
-
|
14,309,523
|
-
|
-
|
-
|
14,310,057
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Jan 2005,
$0.85
|
-
|
-
|
18,000
|
18
|
-
|
-
|
15,282
|
-
|
-
|
-
|
15,300
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Jan 2005,
$0.75
|
-
|
-
|
40,000
|
40
|
-
|
-
|
29,960
|
-
|
-
|
-
|
30,000
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Feb 2005,
$0.69
|
-
|
-
|
18,000
|
18
|
-
|
-
|
12,402
|
-
|
-
|
-
|
12,420
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of principal and interest due,
$4,000,000,
Feb 2005
|
-
|
-
|
250,910
|
251
|
-
|
-
|
181,262
|
-
|
-
|
-
|
181,513
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Feb 2005,
$0.68
|
-
|
-
|
50,000
|
50
|
-
|
-
|
33,950
|
-
|
-
|
-
|
34,000
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of principal and interest due,
$4,000,000,
Mar 2005
|
-
|
-
|
265,228
|
265
|
-
|
-
|
162,197
|
-
|
-
|
-
|
162,462
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of principal and interest due,
$4,000,000,
Apr 2005
|
-
|
-
|
314,732
|
315
|
-
|
-
|
162,275
|
-
|
-
|
-
|
162,590
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $143,500 of
$4,000,000
debenture, Apr 2005
|
-
|
-
|
175,316
|
175
|
-
|
-
|
143,584
|
-
|
-
|
-
|
143,759
|
|||||||||||||||||||||||
Issuance
of common stock as employee compensation, Apr 2005, $0.56
|
-
|
-
|
8,800
|
9
|
-
|
-
|
4,919
|
-
|
-
|
-
|
4,928
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, $500,000,
Apr
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
245,521
|
-
|
-
|
-
|
245,521
|
|||||||||||||||||||||||
Value
of beneficial conversion feature on convertible debentures,
$500,000, Apr
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
86,984
|
-
|
-
|
-
|
86,984
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, $100,000,
Apr
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
49,104
|
-
|
-
|
-
|
49,104
|
|||||||||||||||||||||||
Value
of beneficial conversion feature on convertible debentures,
$100,000, Apr
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
17,397
|
-
|
-
|
-
|
17,397
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for services rendered Apr 2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
40,000
|
-
|
-
|
-
|
40,000
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, Apr 2005,
$0.82
|
-
|
-
|
350,000
|
350
|
-
|
-
|
286,650
|
-
|
-
|
-
|
287,000
|
F-17
Issuance
of common stock in satisfaction of accounts payable, Apr 2005,
$0.82
|
-
|
-
|
950,927
|
951
|
-
|
-
|
778,809
|
-
|
-
|
-
|
779,760
|
|||||||||||||||||||||||
Granting
of stock options in exchange for outstanding liabilities, Apr
2005, $0.001
|
-
|
-
|
-
|
-
|
-
|
-
|
1,332,052
|
-
|
-
|
-
|
1,332,052
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of principal and interest due,
$4,000,000,
May 2005
|
-
|
-
|
482,071
|
482
|
-
|
-
|
321,877
|
-
|
-
|
-
|
322,359
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $300,000 of
$4,000,000
debenture, May 2005
|
-
|
-
|
365,914
|
366
|
-
|
-
|
299,683
|
-
|
-
|
-
|
300,049
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $244,000 of
$4,000,000
debenture, May 2005
|
-
|
-
|
297,659
|
298
|
-
|
-
|
243,783
|
-
|
-
|
-
|
244,081
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $410,000 of
$4,000,000
debenture, May 2005
|
-
|
-
|
500,000
|
500
|
-
|
-
|
409,500
|
-
|
-
|
-
|
410,000
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with 1st extension of due date of
$600,000
convertible debentures, May 2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
717,073
|
-
|
-
|
-
|
717,073
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of principal and interest due,
$4,000,000,
June 2005
|
-
|
-
|
311,307
|
311
|
-
|
-
|
244,644
|
-
|
-
|
-
|
244,955
|
|||||||||||||||||||||||
Issuance
of common stock in conjunction with financing, $2,000,000,
June 2005,
$0.82
|
-
|
-
|
170,732
|
171
|
-
|
-
|
139,829
|
-
|
-
|
-
|
140,000
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with financing, $2,000,000, June
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
20,300
|
-
|
-
|
-
|
20,300
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, $2,000,000,
June
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
828,571
|
-
|
-
|
-
|
828,571
|
|||||||||||||||||||||||
Value
of beneficial conversion feature on convertible debentures,
$2,000,000,
June 2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
1,171,429
|
-
|
-
|
-
|
1,171,429
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $100,000 of
$2,000,000
debenture, June 2005
|
-
|
-
|
166,667
|
167
|
-
|
-
|
99,833
|
-
|
-
|
-
|
100,000
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $190,000 of
$2,000,000
debenture, June 2005
|
-
|
-
|
316,927
|
317
|
-
|
-
|
189,839
|
-
|
-
|
-
|
190,156
|
|||||||||||||||||||||||
Issuance
of common stock In exchange for services rendered, June 2005,
$0.60
|
-
|
-
|
63,207
|
63
|
-
|
-
|
37,861
|
-
|
-
|
-
|
37,924
|
|||||||||||||||||||||||
Issuance
of common stock in satisfaction of accounts payable, June 2005,
$0.82
|
-
|
-
|
90,319
|
90
|
-
|
-
|
73,971
|
-
|
-
|
-
|
74,061
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $17,000 of
$2,000,000
debenture, July 2005
|
-
|
-
|
28,398
|
28
|
-
|
-
|
17,011
|
-
|
-
|
-
|
17,039
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $75,000 of
$2,000,000
debenture, July 2005
|
-
|
-
|
125,000
|
125
|
-
|
-
|
75,035
|
-
|
-
|
-
|
75,160
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with 2nd extension of due date of
$600,000
convertible debentures, July 2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
629,268
|
-
|
-
|
-
|
629,268
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of principal and interest due,
$4,000,000,
July 2005
|
-
|
-
|
364,123
|
364
|
-
|
-
|
237,586
|
-
|
-
|
-
|
237,950
|
|||||||||||||||||||||||
Issuance
of common stock in satisfaction of accounts payable, July 2005,
$0.82
|
-
|
-
|
820,128
|
820
|
-
|
-
|
671,685
|
-
|
-
|
-
|
672,505
|
|||||||||||||||||||||||
Granting
of stock options in exchange for services, July 2004, $0.63
|
-
|
-
|
-
|
-
|
-
|
-
|
17,155
|
-
|
-
|
-
|
17,155
|
|||||||||||||||||||||||
Accrued
interest on note receivable
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(6,300
|
)
|
-
|
-
|
(6,300
|
)
|
|||||||||||||||||||||
Write-off
of uncollectible notes receivable - common stock
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
391,103
|
-
|
-
|
391,103
|
|||||||||||||||||||||||
Variable
accounting non-cash compensation expense
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(24,001,735
|
)
|
-
|
(24,001,735
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss)
|
||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
272,478
|
272,478
|
|||||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(24,001,735
|
)
|
272,478
|
(23,729,257
|
)
|
|||||||||||||||||||||||||||||
Balance
at July 31, 2005
|
1,000
|
$
|
1
|
41,933,898
|
$
|
41,935
|
-
|
$
|
-
|
$
|
126,044,326
|
$
|
-
|
$
|
(120,528,108
|
)
|
$
|
568,849
|
$
|
6,127,003
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-18
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31,
2007
|
|
SVR
Preferred Stock
|
Common
Stock
|
Treasury
Stock
|
Additional
Paid-In
|
Notes
Receivable - Common
|
Deficit
Accumulated During the Development
|
Accumulated
Other Comprehensive
|
Total
Stockholders’
|
|||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stock
|
Stage
|
Income
(Loss)
|
Equity
|
|||||||||||||||||||||||
Balance,
August 1, 2005
|
1,000
|
$
|
1
|
41,933,898
|
$
|
41,935
|
-
|
$
|
-
|
$
|
126,044,326
|
$
|
-
|
$
|
(120,528,108
|
)
|
$
|
568,849
|
$
|
6,127,003
|
||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$4,000,000, August 2005
|
-
|
-
|
429,041
|
429
|
-
|
-
|
282,738
|
-
|
-
|
-
|
283,167
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered August
2005 (at
$0.61)
|
-
|
-
|
19,500
|
19
|
-
|
-
|
11,877
|
-
|
-
|
-
|
11,896
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered August
2005 (at
$0.59)
|
-
|
-
|
246,429
|
246
|
-
|
-
|
145,147
|
-
|
-
|
-
|
145,393
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$4,000,000, September 2005
|
-
|
-
|
388,730
|
389
|
-
|
-
|
267,835
|
-
|
-
|
-
|
268,224
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$2,000,000, September 2005
|
-
|
-
|
322,373
|
322
|
-
|
-
|
222,115
|
-
|
-
|
-
|
222,437
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $504,538 of
$2,000,000
debenture, September 2005
|
-
|
-
|
841,309
|
841
|
-
|
-
|
503,945
|
-
|
-
|
-
|
504,786
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $286,538 of
$2,000,000
debenture, September 2005
|
-
|
-
|
477,962
|
478
|
-
|
-
|
286,299
|
-
|
-
|
-
|
286,777
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $457,200 of
2nd
$2,000,000 debenture, September 2005
|
-
|
-
|
762,000
|
762
|
-
|
-
|
456,739
|
-
|
-
|
-
|
457,501
|
|||||||||||||||||||||||
Issuance
of common stock in satisfaction of accounts payable, September
2005, $0.81
|
-
|
-
|
162,933
|
163
|
-
|
-
|
113,442
|
-
|
-
|
-
|
113,605
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $211,538 of
$2,000,000
debenture, September 2005
|
-
|
-
|
353,665
|
354
|
-
|
-
|
211,845
|
-
|
-
|
-
|
212,199
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $150,000 of
2nd
$2,000,000 debenture, September 2005
|
-
|
-
|
250,000
|
250
|
-
|
-
|
149,750
|
-
|
-
|
-
|
150,000
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $457,317 of
2nd
$2,000,000 debenture, September 2005
|
-
|
-
|
762,195
|
762
|
-
|
-
|
458,209
|
-
|
-
|
-
|
458,971
|
|||||||||||||||||||||||
Issuance
of common stock in conjunction with financing, 2nd $2,000,000,
September
2005, $0.82
|
-
|
-
|
170,732
|
171
|
-
|
-
|
139,829
|
-
|
-
|
-
|
140,000
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with financing, 2nd $2,000,000,
September 2005,
$0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
30,600
|
-
|
-
|
-
|
30,600
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, 2nd
$2,000,000,
September 2005 (at $0.82)
|
-
|
-
|
-
|
-
|
-
|
-
|
785,185
|
-
|
-
|
-
|
785,185
|
|||||||||||||||||||||||
Value
of Beneficial Conversion Feature on Convertible Debentures,
2nd
$2,000,000, September 2005 (at $0.82)
|
-
|
-
|
-
|
-
|
-
|
-
|
1,185,185
|
-
|
-
|
-
|
1,185,185
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$4,000,000, October 2005
|
-
|
-
|
243,836
|
244
|
-
|
-
|
163,126
|
-
|
-
|
-
|
163,370
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$2,000,000, October 2005
|
-
|
-
|
67,949
|
68
|
-
|
-
|
45,458
|
-
|
-
|
-
|
45,526
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $307,317 of
2nd
$2,000,000 debenture, October 2005
|
-
|
-
|
512,195
|
512
|
-
|
-
|
306,805
|
-
|
-
|
-
|
307,317
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $300,000 of
$2,000,000
debenture, October 2005
|
-
|
-
|
501,397
|
501
|
-
|
-
|
300,337
|
-
|
-
|
-
|
300,838
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $500,000 of
$500,000
debenture, October 2005
|
-
|
-
|
644,003
|
644
|
-
|
-
|
527,438
|
-
|
-
|
-
|
528,082
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $113,077 of
$2,000,000
debenture, October 2005
|
-
|
-
|
189,019
|
189
|
-
|
-
|
113,222
|
-
|
-
|
-
|
113,411
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $297,692 of
$4,000,000
debenture, October 2005
|
-
|
-
|
364,113
|
364
|
-
|
-
|
298,209
|
-
|
-
|
-
|
298,573
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, October 2005, $0.82
|
-
|
-
|
8,404,876
|
8,405
|
-
|
-
|
6,883,593
|
-
|
-
|
-
|
6,891,998
|
|||||||||||||||||||||||
Exercise
of stock options for cash, October 2005, $0.63
|
-
|
-
|
101,500
|
101
|
-
|
-
|
63,844
|
-
|
-
|
-
|
63,945
|
F-19
Exercise
of stock options for cash, October 2005, $0.94
|
-
|
-
|
40,000
|
40
|
-
|
-
|
37,560
|
-
|
-
|
-
|
37,600
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $100,000 of
$100,000
debenture, October 2005
|
-
|
-
|
128,834
|
129
|
-
|
-
|
105,515
|
-
|
-
|
-
|
105,644
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with financing, $500,000, October
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
14,250
|
-
|
-
|
-
|
14,250
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, $500,000,
October
2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
270,950
|
-
|
-
|
-
|
270,950
|
|||||||||||||||||||||||
Issuance
of warrants as exercise inducement Oct 2005, $1.20
|
-
|
-
|
-
|
-
|
-
|
-
|
573,146
|
-
|
-
|
-
|
573,146
|
|||||||||||||||||||||||
Issuance
of warrants as exercise inducement Oct 2005, $1.25
|
-
|
-
|
-
|
-
|
-
|
-
|
2,501,390
|
-
|
-
|
-
|
2,501,390
|
|||||||||||||||||||||||
Value
of Beneficial Conversion Feature on Convertible Debentures,
$500,000,
October 2005 (at $0.82)
|
-
|
-
|
-
|
-
|
-
|
-
|
229,050
|
-
|
-
|
-
|
229,050
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$4,000,000, Nov 2005, $1.17
|
-
|
-
|
108,006
|
108
|
-
|
-
|
126,259
|
-
|
-
|
-
|
126,367
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$2,000,000, Nov 2005, $1.17
|
-
|
-
|
16,753
|
17
|
-
|
-
|
19,584
|
-
|
-
|
-
|
19,601
|
|||||||||||||||||||||||
Exercise
of stock options for cash, November 2005, $0.94
|
-
|
-
|
100,000
|
100
|
-
|
-
|
93,900
|
-
|
-
|
-
|
94,000
|
|||||||||||||||||||||||
Exercise
of stock options for cash, November 2005, $0.63
|
-
|
-
|
1,500
|
2
|
-
|
-
|
944
|
-
|
-
|
-
|
946
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, November 2005, $0.82
|
-
|
-
|
3,058,536
|
3,058
|
-
|
-
|
2,504,942
|
-
|
-
|
-
|
2,508,000
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered November
2005, $0.97
|
-
|
-
|
64,287
|
64
|
-
|
-
|
62,294
|
-
|
-
|
-
|
62,358
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $42,800 of
2nd $2,000,000
debenture, Nov 2005, $1.23
|
-
|
-
|
72,058
|
72
|
-
|
-
|
88,559
|
-
|
-
|
-
|
88,631
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered August
2005, $0.97
|
-
|
-
|
19,500
|
19
|
-
|
-
|
18,897
|
-
|
-
|
-
|
18,916
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $230,769 of
$4,000,000
debenture, November 2005,$0.97
|
-
|
-
|
282,721
|
283
|
-
|
-
|
273,957
|
-
|
-
|
-
|
274,240
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$2,000,000, Dec 2005, $0.98
|
-
|
-
|
212,750
|
213
|
-
|
-
|
208,282
|
-
|
-
|
-
|
208,495
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $1,451,000
of $3,500,000
debenture, Dec 2005, $0.93
|
-
|
-
|
1,770,223
|
1,770
|
-
|
-
|
1,644,537
|
-
|
-
|
-
|
1,646,307
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $4,221 of
2nd $2,000,000
debenture, Dec 2005, $0.85
|
-
|
-
|
7,042
|
7
|
-
|
-
|
5,979
|
-
|
-
|
-
|
5,986
|
|||||||||||||||||||||||
Issuance
of common stock in conjunction with financing, $3,500,000,
December 2005,
$0.95
|
-
|
-
|
224,000
|
224
|
-
|
-
|
212,576
|
-
|
-
|
-
|
212,800
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with financing, $3,500,000, December
2005,
$0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
76,650
|
-
|
-
|
-
|
76,650
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, $3,500,000,
December 2005, $0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
1,648,387
|
-
|
-
|
-
|
1,648,387
|
|||||||||||||||||||||||
Value
of Beneficial Conversion Feature on Convertible Debentures,
$3,500,000,
December 2005,$0.82
|
-
|
-
|
-
|
-
|
-
|
-
|
1,851,613
|
-
|
-
|
-
|
1,851,613
|
|||||||||||||||||||||||
Issuance
of warrants as exercise inducement Dec 2005, $1.25
|
-
|
-
|
-
|
-
|
-
|
-
|
1,115,853
|
-
|
-
|
-
|
1,115,853
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $82,000 of
$3,500,000
debenture, December 2005, $0.84
|
-
|
-
|
100,000
|
100
|
-
|
-
|
83,900
|
-
|
-
|
-
|
84,000
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, 2nd
$2,000,000, Jan 2006, $0.81
|
-
|
-
|
75,149
|
75
|
-
|
-
|
60,796
|
-
|
-
|
-
|
60,871
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$500,000, Jan 2006, $0.81
|
-
|
-
|
53,612
|
54
|
-
|
-
|
43,372
|
-
|
-
|
-
|
43,426
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $617,000 of
$3,500,000
debenture, January 2005, $0.94
|
-
|
-
|
757,630
|
758
|
-
|
-
|
711,415
|
-
|
-
|
-
|
712,173
|
|||||||||||||||||||||||
Issuance
of common stock in conjunction with financing, $4,000,000,
January 2006,
$1.00
|
-
|
-
|
266,667
|
267
|
-
|
-
|
266,400
|
-
|
-
|
-
|
266,667
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with financing, $4,000,000, January
2006, $1.05
|
-
|
-
|
-
|
-
|
-
|
-
|
88,800
|
-
|
-
|
-
|
88,800
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, 4,000,000,
January
2006, $1.05
|
-
|
-
|
-
|
-
|
-
|
-
|
1,653,631
|
-
|
-
|
-
|
1,653,631
|
|||||||||||||||||||||||
Value
of Beneficial Conversion Feature on Convertible Debentures,
4,000,000,
January 2006, $1.05
|
-
|
-
|
-
|
-
|
-
|
-
|
1,463,155
|
-
|
-
|
-
|
1,463,155
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, January 2006, $0.82
|
-
|
-
|
7,317,072
|
7,317
|
-
|
-
|
5,992,682
|
-
|
-
|
-
|
5,999,999
|
|||||||||||||||||||||||
Issuance
of warrants as exercise inducement Jan 2006, $1.60
|
-
|
-
|
-
|
-
|
-
|
-
|
3,109,756
|
-
|
-
|
-
|
3,109,756
|
F-20
Exercise
of stock options for cash, January 2006, $0.63
|
-
|
-
|
10,000
|
10
|
-
|
-
|
6,290
|
-
|
-
|
-
|
6,300
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $850,000 of
$3,500,000
debenture, January 2006, $1.06
|
-
|
-
|
1,045,779
|
1,046
|
-
|
-
|
1,107,480
|
-
|
-
|
-
|
1,108,526
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$500,000, Feb 2006, $1.23
|
-
|
-
|
49,812
|
50
|
-
|
-
|
61,219
|
-
|
-
|
-
|
61,269
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$2,000,000, Feb 2006, $1.23
|
-
|
-
|
67,746
|
68
|
-
|
-
|
83,260
|
-
|
-
|
-
|
83,328
|
|||||||||||||||||||||||
Issuance
of common stock as employee compensation, December 2005, $0.90
|
-
|
-
|
140,115
|
140
|
-
|
-
|
125,964
|
-
|
-
|
-
|
126,104
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, February 2006, $0.82
|
-
|
-
|
303,902
|
304
|
-
|
-
|
248,896
|
-
|
-
|
-
|
249,200
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered February
2006, $1.53
|
-
|
-
|
50,000
|
50
|
-
|
-
|
76,450
|
-
|
-
|
-
|
76,500
|
|||||||||||||||||||||||
Exercise
of stock options for cash, February 2006, $0.94
|
-
|
-
|
80,000
|
80
|
-
|
-
|
75,120
|
-
|
-
|
-
|
75,200
|
|||||||||||||||||||||||
Exercise
of stock options for cash, February 2006, $1.59
|
-
|
-
|
80,000
|
80
|
-
|
-
|
127,120
|
-
|
-
|
-
|
127,200
|
|||||||||||||||||||||||
Exercise
of stock options for cash, February 2006, $1.38
|
-
|
-
|
20,000
|
20
|
-
|
-
|
27,580
|
-
|
-
|
-
|
27,600
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, February 2006, $1.05
|
-
|
-
|
3,809,524
|
3,810
|
-
|
-
|
3,996,191
|
-
|
-
|
-
|
4,000,001
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, February 2006, $1.20
|
-
|
-
|
909,756
|
910
|
-
|
-
|
1,090,797
|
-
|
-
|
-
|
1,091,707
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, February 2006, $1.25
|
-
|
-
|
4,578,048
|
4,578
|
-
|
-
|
5,717,982
|
-
|
-
|
-
|
5,722,560
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, February 2006, $1.72
|
-
|
-
|
34,782
|
35
|
-
|
-
|
59,790
|
-
|
-
|
-
|
59,825
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $950,000 of
Jan
$4,000,000 debenture, Feb 2006, $2.38
|
-
|
-
|
904,762
|
905
|
-
|
-
|
2,152,429
|
-
|
-
|
-
|
2,153,334
|
|||||||||||||||||||||||
Issuance
of warrants in conjunction with convertible debentures, 4,000,000,
February 2006, $1.05
|
-
|
-
|
-
|
-
|
-
|
-
|
2,374,507
|
-
|
-
|
-
|
2,374,507
|
|||||||||||||||||||||||
Value
of Beneficial Conversion Feature on Convertible Debentures,
4,000,000,
February 2006, $1.05
|
-
|
-
|
-
|
-
|
-
|
-
|
1,625,493
|
-
|
-
|
-
|
1,625,493
|
|||||||||||||||||||||||
Issuance
of warrants as exercise inducement Feb 2006, $3.00
|
-
|
-
|
-
|
-
|
-
|
-
|
8,294,141
|
-
|
-
|
-
|
8,294,141
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $1,550,000
of Jan
$4,000,000 debenture, Mar 2006, $2.21
|
-
|
-
|
1,485,349
|
1,485
|
-
|
-
|
3,281,136
|
-
|
-
|
-
|
3,282,621
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $1.72
|
-
|
-
|
347,913
|
348
|
-
|
-
|
598,062
|
-
|
-
|
-
|
598,410
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$2,000,000, Mar 2006, $2.31
|
-
|
-
|
67,094
|
67
|
-
|
-
|
154,920
|
-
|
-
|
-
|
154,987
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$500,000, March 2006, $2.31
|
-
|
-
|
49,312
|
49
|
-
|
-
|
113,861
|
-
|
-
|
-
|
113,910
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$3,500,000, Mar 2006, $2.31
|
-
|
-
|
55,644
|
56
|
-
|
-
|
128,482
|
-
|
-
|
-
|
128,538
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered March
2006, $2.31
|
-
|
-
|
50,000
|
50
|
-
|
-
|
115,450
|
-
|
-
|
-
|
115,500
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $0.94
|
-
|
-
|
300,222
|
300
|
-
|
-
|
281,909
|
-
|
-
|
-
|
282,209
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $2,350,000
of Feb
$4,000,000 debenture, Mar 2006, $2.31
|
-
|
-
|
1,880,000
|
1,880
|
-
|
-
|
4,340,920
|
-
|
-
|
-
|
4,342,800
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $1.47
|
-
|
-
|
274,500
|
274
|
-
|
-
|
403,241
|
-
|
-
|
-
|
403,515
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $1.25
|
-
|
-
|
1,600,000
|
1,600
|
-
|
-
|
1,998,400
|
-
|
-
|
-
|
2,000,000
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $0.91
|
-
|
-
|
60,000
|
60
|
-
|
-
|
54,540
|
-
|
-
|
-
|
54,600
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $1.59
|
-
|
-
|
263,700
|
264
|
-
|
-
|
419,019
|
-
|
-
|
-
|
419,283
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $500,000 of
Feb
$4,000,000 debenture, Mar 2006, $2.20
|
-
|
-
|
400,592
|
401
|
-
|
-
|
880,902
|
-
|
-
|
-
|
881,303
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $0.82
|
-
|
-
|
48,000
|
48
|
-
|
-
|
39,312
|
-
|
-
|
-
|
39,360
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $1.05
|
-
|
-
|
46,000
|
46
|
-
|
-
|
48,254
|
-
|
-
|
-
|
48,300
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $200,000 of
Jan
$4,000,000 debenture, March 2006, $2.31
|
-
|
-
|
192,136
|
192
|
-
|
-
|
443,642
|
-
|
-
|
-
|
443,834
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $1.71
|
-
|
-
|
180,000
|
180
|
-
|
-
|
307,620
|
-
|
-
|
-
|
307,800
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $384,615 of
$500,000
debenture, March 2006, $3.33
|
-
|
-
|
470,450
|
470
|
-
|
-
|
1,566,129
|
-
|
-
|
-
|
1,566,599
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $1.68
|
-
|
-
|
1,639,344
|
1,639
|
-
|
-
|
2,752,459
|
-
|
-
|
-
|
2,754,098
|
|||||||||||||||||||||||
Cashless
exercise of stock warrants, March 2006, $2.50
|
-
|
-
|
8,179
|
8
|
-
|
-
|
(8
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $1.25
|
-
|
-
|
68,000
|
68
|
-
|
-
|
84,932
|
-
|
-
|
-
|
85,000
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $2.10
|
-
|
-
|
175,000
|
175
|
-
|
-
|
367,325
|
-
|
-
|
-
|
367,500
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $1.10
|
-
|
-
|
150,000
|
150
|
-
|
-
|
164,850
|
-
|
-
|
-
|
165,000
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $1.52
|
-
|
-
|
150,000
|
150
|
-
|
-
|
227,850
|
-
|
-
|
-
|
228,000
|
F-21
Exercise
of stock options for cash, March 2006, $2.19
|
-
|
-
|
150,000
|
150
|
-
|
-
|
328,350
|
-
|
-
|
-
|
328,500
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $2.15
|
-
|
-
|
2,000
|
2
|
-
|
-
|
4,298
|
-
|
-
|
-
|
4,300
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $1.88
|
-
|
-
|
31,000
|
31
|
-
|
-
|
58,249
|
-
|
-
|
-
|
58,280
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $2.02
|
-
|
-
|
23,438
|
23
|
-
|
-
|
47,322
|
-
|
-
|
-
|
47,345
|
|||||||||||||||||||||||
Exercise
of stock options for cash, March 2006, $0.63
|
-
|
-
|
120,750
|
121
|
-
|
-
|
75,952
|
-
|
-
|
-
|
76,073
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, March 2006, $1.86
|
-
|
-
|
170,068
|
170
|
-
|
-
|
316,156
|
-
|
-
|
-
|
316,326
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered March
2006, $2.96
|
-
|
-
|
25,000
|
25
|
-
|
-
|
73,975
|
-
|
-
|
-
|
74,000
|
|||||||||||||||||||||||
Issuance
of common stock in satisfaction of accounts payable March 2006,
$3.20
|
-
|
-
|
2,390
|
2
|
-
|
-
|
7,646
|
-
|
-
|
-
|
7,648
|
|||||||||||||||||||||||
Issuance
of warrants as exercise inducement Mar 2006, $3.00
|
-
|
-
|
-
|
-
|
-
|
-
|
1,293,953
|
-
|
-
|
-
|
1,293,953
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$2,000,000, April 2006, $2.70
|
-
|
-
|
67,083
|
67
|
-
|
-
|
181,057
|
-
|
-
|
-
|
181,124
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due,
$3,500,000, April 2006, $2.70
|
-
|
-
|
49,812
|
50
|
-
|
-
|
134,443
|
-
|
-
|
-
|
134,493
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, Jan
$4,000,000, Apr 2006, $2.70
|
-
|
-
|
167,144
|
167
|
-
|
-
|
451,122
|
-
|
-
|
-
|
451,289
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, April 2006, $1.88
|
-
|
-
|
29,000
|
29
|
-
|
-
|
54,491
|
-
|
-
|
-
|
54,520
|
|||||||||||||||||||||||
Exercise
of stock options for cash, April 2006, $1.47
|
-
|
-
|
95,500
|
95
|
-
|
-
|
140,290
|
-
|
-
|
-
|
140,385
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $307,692 of
2nd
$2,000,000 debenture, April 2006, $2.63
|
-
|
-
|
513,158
|
513
|
-
|
-
|
1,349,092
|
-
|
-
|
-
|
1,349,605
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $423,077 of
$3,500,000
debenture, April 2005, $2.63
|
-
|
-
|
516,291
|
516
|
-
|
-
|
1,357,329
|
-
|
-
|
-
|
1,357,845
|
|||||||||||||||||||||||
Issuance
of common stock in connection with conversion of $923,077 of
Jan
$4,000,000 debenture, April 2006, $2.63
|
-
|
-
|
879,699
|
880
|
-
|
-
|
2,312,729
|
-
|
-
|
-
|
2,313,609
|
|||||||||||||||||||||||
Exercise
of stock options for cash, April 2006, $0.94
|
-
|
-
|
25,000
|
25
|
-
|
-
|
23,475
|
-
|
-
|
-
|
23,500
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, April 2006, $0.82
|
-
|
-
|
132,000
|
132
|
-
|
-
|
108,108
|
-
|
-
|
-
|
108,240
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, April 2006, $0.91
|
-
|
-
|
60,000
|
60
|
-
|
-
|
54,540
|
-
|
-
|
-
|
54,600
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, April 2006, $1.05
|
-
|
-
|
69,000
|
69
|
-
|
-
|
72,381
|
-
|
-
|
-
|
72,450
|
|||||||||||||||||||||||
Issuance
of common stock in satisfaction of deposit April 2006, $1.25
|
-
|
-
|
204,465
|
204
|
-
|
-
|
255,377
|
-
|
-
|
-
|
255,581
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered April
2006, $2.67
|
-
|
-
|
38,400
|
38
|
-
|
-
|
102,490
|
-
|
-
|
-
|
102,528
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for the services rendered April 2006,
$2.66
|
-
|
-
|
-
|
-
|
-
|
-
|
137,200
|
-
|
-
|
-
|
137,200
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, Jan
$4,000,000, May 2006, $3.10
|
-
|
-
|
74,322
|
74
|
-
|
-
|
230,324
|
-
|
-
|
-
|
230,398
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, Feb
$4,000,000, May 2006, $3.10
|
-
|
-
|
172,713
|
173
|
-
|
-
|
535,238
|
-
|
-
|
-
|
535,411
|
|||||||||||||||||||||||
Exercise
of stock options for cash, May 2006, $2.10
|
-
|
-
|
25,000
|
25
|
-
|
-
|
52,475
|
-
|
-
|
-
|
52,500
|
|||||||||||||||||||||||
Exercise
of stock options for cash, May 2006, $1.47
|
-
|
-
|
10,000
|
10
|
-
|
-
|
14,690
|
-
|
-
|
-
|
14,700
|
|||||||||||||||||||||||
Issuance
of warrants in exchange for the services rendered May 2006,
$1.91
|
-
|
-
|
-
|
-
|
-
|
-
|
35,250
|
-
|
-
|
-
|
35,250
|
|||||||||||||||||||||||
Issuance
of common stock as employee compensation May 2006, $1.88
|
-
|
-
|
755,000
|
755
|
-
|
-
|
1,418,645
|
-
|
-
|
-
|
1,419,400
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered May 2006,
$1.85
|
-
|
-
|
3,784
|
4
|
-
|
-
|
6,997
|
-
|
-
|
-
|
7,001
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered May 2006,
$1.88
|
-
|
-
|
38,000
|
38
|
-
|
-
|
71,402
|
-
|
-
|
-
|
71,440
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, Jan
$4,000,000, Jun 2006, $1.96
|
-
|
-
|
73,979
|
74
|
-
|
-
|
144,925
|
-
|
-
|
-
|
144,999
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, Feb
$4,000,000, Jun 2006, $1.96
|
-
|
-
|
83,911
|
84
|
-
|
-
|
164,382
|
-
|
-
|
-
|
164,466
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, June 2006, $1.25
|
-
|
-
|
1,327,880
|
1,328
|
-
|
-
|
1,658,522
|
-
|
-
|
-
|
1,659,850
|
|||||||||||||||||||||||
Exercise
of stock warrants for cash, June 2006, $1.60
|
-
|
-
|
3,036,310
|
3,036
|
-
|
-
|
4,855,060
|
-
|
-
|
-
|
4,858,096
|
|||||||||||||||||||||||
Issuance
of warrants as exercise inducement June 2006, $2.35
|
-
|
-
|
-
|
-
|
-
|
-
|
4,549,670
|
-
|
-
|
-
|
4,549,670
|
|||||||||||||||||||||||
Issuance
of common stock for cash pursuant to private placement, June
2006, $2.05
|
-
|
-
|
3,414,636
|
3,415
|
-
|
-
|
6,996,589
|
-
|
-
|
-
|
7,000,004
|
F-22
Issuance
of common stock in exchange for the services rendered June
2006, $1.85
|
-
|
-
|
3,784
|
4
|
-
|
-
|
6,997
|
-
|
-
|
-
|
7,001
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, Jan
$4,000,000, July 2006, $1.75
|
-
|
-
|
66,264
|
66
|
-
|
-
|
115,896
|
-
|
-
|
-
|
115,962
|
|||||||||||||||||||||||
Issuance
of common stock as repayment of monthly amortization payments
due, Feb
$4,000,000, July 2006, $1.75
|
-
|
-
|
64,923
|
65
|
-
|
-
|
113,550
|
-
|
-
|
-
|
113,615
|
|||||||||||||||||||||||
Issuance
of common stock in exchange for the services rendered July
2006, $1.40
|
-
|
-
|
5,000
|
5
|
-
|
-
|
6,995
|
-
|
-
|
-
|
7,000
|
|||||||||||||||||||||||
Comprehensive
Income (Loss):
|
||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(67,967,204
|
)
|
-
|
(67,967,204
|
)
|
|||||||||||||||||||||
Other
comprehensive income (loss)
|
||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
185,232
|
185,232
|
|||||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(67,967,204
|
)
|
185,232
|
(67,781,972
|
)
|
|||||||||||||||||||||||||||||
Balance
at July 31, 2006
|
1,000
|
$
|
1
|
107,398,360
|
$
|
107,397
|
$
|
-
|
$
|
-
|
$
|
243,097,627
|
$
|
-
|
$
|
(188,495,312
|
)
|
$
|
754,081
|
$
|
55,463,794
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-23
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
|
(A
DEVELOPMENT STAGE COMPANY)
|
|
STATEMENT
OF CHANGES IN STOCKHOLDERS' EQUITY
|
|
FOR
THE PERIOD NOVEMBER 2, 1995 (DATE OF INCEPTION) TO JULY 31, 2007
|
Deficit
|
|||||||||||||||||||||||||||||||||||||
SVR
|
Notes
|
Accumulated
|
Accumulated
|
||||||||||||||||||||||||||||||||||
Preferred
|
Common
|
Treasury
|
Additional
|
Receivable-
|
During
the
|
Other
|
Total
|
||||||||||||||||||||||||||||||
Stock
|
Stock
|
Stock
|
Paid-In
|
Common
|
Development
|
Comprehensive
|
Stockholders’
|
||||||||||||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Stock
|
|
Stage
|
|
Income
(Loss)
|
|
Equity
|
|||||||||||||||||
Balance,
August 1, 2006
|
1,000
|
$
|
1
|
107,398,360
|
$
|
107,397
|
$
|
-
|
$
|
-
|
$
|
243,097,627
|
$
|
-
|
$
|
(188,495,312
|
)
|
$
|
754,081
|
$
|
55,463,794
|
||||||||||||||||
Issuance
of common stock as repayment
of
monthly amortization
|
|||||||||||||||||||||||||||||||||||||
payments
due, Feb $4,000,000, Aug 2006, $1.48
|
-
|
-
|
64,718
|
65
|
-
|
-
|
95,718
|
-
|
-
|
-
|
95,783
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Aug
|
|||||||||||||||||||||||||||||||||||||
2006,
$1.43
|
-
|
-
|
25,000
|
25
|
-
|
-
|
35,725
|
-
|
-
|
-
|
35,750
|
||||||||||||||||||||||||||
Issuance
of common stock as repayment
of
monthly amortization payments due
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000, Sep 2006 $1.53
|
-
|
-
|
64,400
|
64
|
-
|
-
|
98,468
|
-
|
-
|
-
|
98,532
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Oct
|
|||||||||||||||||||||||||||||||||||||
2006,
$1.50
|
-
|
-
|
25,000
|
25
|
-
|
-
|
37,475
|
-
|
-
|
-
|
37,500
|
||||||||||||||||||||||||||
Issuance
of common stock as repayment
of
monthly amortization payments due ,
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000, Oct 2006, $1.65
|
-
|
-
|
64,000
|
64
|
-
|
-
|
105,536
|
-
|
-
|
-
|
105,600
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Oct
|
|||||||||||||||||||||||||||||||||||||
2006,
$1.83
|
-
|
-
|
27,262
|
27
|
-
|
-
|
49,862
|
-
|
-
|
-
|
49,889
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Oct
|
|||||||||||||||||||||||||||||||||||||
2006,
$1.50
|
-
|
-
|
25,000
|
25
|
-
|
-
|
37,475
|
-
|
-
|
-
|
37,500
|
||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation
Oct 2006, $1.83
|
-
|
-
|
100,000
|
100
|
-
|
-
|
182,900
|
-
|
-
|
-
|
183,000
|
||||||||||||||||||||||||||
Exercise
of stock warrants for cash, Oct 2006, $1.25
|
-
|
-
|
100,000
|
100
|
-
|
-
|
124,900
|
-
|
-
|
-
|
125,000
|
||||||||||||||||||||||||||
Exercise
of stock options for cash, Oct 2006, $1.59
|
-
|
-
|
90,300
|
90
|
-
|
-
|
143,487
|
-
|
-
|
-
|
143,577
|
||||||||||||||||||||||||||
Exercise
of stock options for cash, Oct 2006, $1.47
|
-
|
-
|
6,500
|
6
|
-
|
-
|
9,549
|
-
|
-
|
-
|
9,555
|
||||||||||||||||||||||||||
Issuance
of common stock as repayment
of
monthly amortization payments due
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000, Nov 2006, $2.02
|
-
|
-
|
63,764
|
64
|
-
|
-
|
128,740
|
-
|
-
|
-
|
128,804
|
||||||||||||||||||||||||||
Exercise
of stock options for cash, Nov 2006,
$1.59
|
-
|
-
|
15,000
|
15
|
-
|
-
|
23,835
|
-
|
-
|
-
|
23,850
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Nov
|
|||||||||||||||||||||||||||||||||||||
2006,
$2.15
|
-
|
-
|
50,000
|
50
|
-
|
-
|
107,450
|
-
|
-
|
-
|
107,500
|
||||||||||||||||||||||||||
Issuance
of common stock as repayment
of
monthly amortization payments due,
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000, Dec 2006, $2.08
|
-
|
-
|
63,384
|
63
|
-
|
-
|
131,775
|
-
|
-
|
-
|
131,838
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered
|
|||||||||||||||||||||||||||||||||||||
Dec
2006, $1.68
|
-
|
-
|
25,000
|
25
|
-
|
-
|
41,975
|
-
|
-
|
-
|
42,000
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Jan
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.77
|
-
|
-
|
25,000
|
25
|
-
|
-
|
44,225
|
-
|
-
|
-
|
44,250
|
||||||||||||||||||||||||||
Issuance
of common stock in connection
with
conversation of $52,554 of
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000 debenture, Jan, $1.74
|
-
|
-
|
42,043
|
42
|
-
|
-
|
73,113
|
-
|
-
|
-
|
73,155
|
||||||||||||||||||||||||||
Issuance
of common stock in connection
with
conversion of 52,554 of
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000 debenture, Jan, $1.77
|
-
|
-
|
42,043
|
42
|
-
|
-
|
74,374
|
-
|
-
|
-
|
74,416
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Feb
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.90
|
-
|
-
|
25,000
|
25
|
-
|
-
|
47,475
|
-
|
-
|
-
|
47,500
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Mar
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.71
|
-
|
-
|
100,000
|
100
|
-
|
-
|
170,900
|
-
|
-
|
-
|
171,000
|
||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation
Mar 2007,
|
|||||||||||||||||||||||||||||||||||||
$1.71
|
-
|
-
|
9,844
|
10
|
-
|
-
|
16,823
|
-
|
-
|
-
|
16,833
|
||||||||||||||||||||||||||
Issuance
of warrants in exchange for the
services
rendered Mar 2007,
|
|||||||||||||||||||||||||||||||||||||
$1.71
|
-
|
-
|
-
|
-
|
125,000
|
-
|
-
|
-
|
125,000
|
||||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation
Mar 2007, $1.71
|
-
|
-
|
296,000
|
296
|
-
|
-
|
505,864
|
-
|
-
|
-
|
506,160
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Mar
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.65
|
-
|
-
|
13,637
|
13
|
-
|
-
|
22,487
|
-
|
-
|
-
|
22,500
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Mar
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.69
|
-
|
-
|
25,000
|
25
|
-
|
-
|
42,225
|
-
|
-
|
-
|
42,250
|
||||||||||||||||||||||||||
Issuance
of common stock in connection
with
conversion of $52,554 of
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000 debenture, Mar 2007, $1.71
|
-
|
-
|
42,043
|
42
|
-
|
-
|
71,851
|
-
|
-
|
-
|
71,893
|
F-24
Issuance
of common stock as employee
compensation
Mar 2007, $1.70
|
-
|
-
|
4,951
|
5
|
-
|
-
|
8,412
|
-
|
-
|
-
|
8,417
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Apr
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.71
|
-
|
-
|
22,728
|
23
|
-
|
-
|
38,842
|
-
|
-
|
-
|
38,865
|
||||||||||||||||||||||||||
Preferred
Shares Redemption, April 2007
|
(1,000
|
)
|
(1
|
)
|
-
|
-
|
-
|
-
|
(99
|
)
|
-
|
-
|
-
|
(100
|
)
|
||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Apr
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.65
|
-
|
-
|
13,637
|
14
|
-
|
-
|
22,486
|
-
|
-
|
-
|
22,500
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Apr
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.69
|
-
|
-
|
25,000
|
25
|
-
|
-
|
42,225
|
-
|
-
|
-
|
42,250
|
||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation
Apr 2007, $1.64
|
-
|
-
|
5,132
|
5
|
-
|
-
|
8,411
|
-
|
-
|
-
|
8,416
|
||||||||||||||||||||||||||
Issuance
of common stock in connection
with
conversion of $52,554 of
|
|||||||||||||||||||||||||||||||||||||
Feb
$4,000,000 debenture, Apr 2007, $1.61
|
-
|
-
|
42,043
|
42
|
-
|
-
|
67,647
|
-
|
-
|
-
|
67,689
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered May
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.60
|
-
|
-
|
22,728
|
23
|
-
|
-
|
36,342
|
-
|
-
|
-
|
36,365
|
||||||||||||||||||||||||||
Exercise
of stock options for cash, May 2007, $0.63
|
-
|
-
|
5,000
|
5
|
-
|
-
|
3,145
|
-
|
-
|
-
|
3,150
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered May
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.47
|
-
|
-
|
25,000
|
25
|
-
|
-
|
36,725
|
-
|
-
|
-
|
36,750
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered May
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.47
|
-
|
-
|
13,637
|
14
|
-
|
-
|
20,033
|
-
|
-
|
-
|
20,047
|
||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation
May 2007, $1.45
|
-
|
-
|
5,805
|
6
|
-
|
-
|
8,411
|
-
|
-
|
-
|
8,417
|
||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation
May 2007, $1.45
|
-
|
-
|
450,000
|
450
|
-
|
-
|
652,050
|
-
|
-
|
-
|
652,500
|
||||||||||||||||||||||||||
Issuance
of warrants in exchange for the
services
rendered May 2007, $1.45
|
-
|
-
|
-
|
-
|
141,400
|
-
|
-
|
-
|
141,400
|
||||||||||||||||||||||||||||
Cancellation
of common stock, May 2007,
$1.45
|
-
|
-
|
(150,000
|
)
|
(150
|
)
|
-
|
-
|
150
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Jun
|
|||||||||||||||||||||||||||||||||||||
2007
, $1.40
|
-
|
-
|
22,728
|
23
|
-
|
-
|
31,796
|
-
|
-
|
-
|
31,819
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Jun
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.83
|
-
|
-
|
13,637
|
14
|
-
|
-
|
24,942
|
-
|
-
|
-
|
24,956
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
services rendered
|
|||||||||||||||||||||||||||||||||||||
Jun
2007, $1.80
|
-
|
-
|
25,000
|
25
|
-
|
-
|
44,975
|
-
|
-
|
-
|
45,000
|
||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation,
Jul 2007, $1.78
|
-
|
-
|
4,728
|
5
|
-
|
-
|
8,411
|
-
|
-
|
-
|
8,416
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Jul
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.78
|
-
|
-
|
22,728
|
23
|
-
|
-
|
40,433
|
-
|
-
|
-
|
40,456
|
||||||||||||||||||||||||||
Exercise
of stock options for cash, Jul 2007,
$0.94
|
-
|
-
|
70,000
|
70
|
-
|
-
|
65,730
|
-
|
-
|
-
|
65,800
|
||||||||||||||||||||||||||
Exercise
of stock options for cash, Jul 2007,
$0.56
|
-
|
-
|
100,000
|
100
|
-
|
-
|
55,900
|
-
|
-
|
-
|
56,000
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Jul
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.75
|
-
|
-
|
13,637
|
14
|
-
|
-
|
23,851
|
-
|
-
|
-
|
23,865
|
||||||||||||||||||||||||||
Issuance
of common stock in exchange
for
the services rendered Jul
|
|||||||||||||||||||||||||||||||||||||
2007,
$1.68
|
-
|
-
|
25,000
|
25
|
-
|
-
|
41,975
|
-
|
-
|
-
|
42,000
|
||||||||||||||||||||||||||
Issuance
of common stock as employee
compensation
April 2007, $1.65
|
-
|
-
|
5,101
|
5
|
-
|
-
|
8,412
|
-
|
-
|
-
|
8,417
|
||||||||||||||||||||||||||
Comprehensive
Income (Loss):
|
|||||||||||||||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(23,504,958
|
)
|
-
|
(23,504,958
|
)
|
||||||||||||||||||||||||
Other
comprehensive income (loss)
|
|||||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
127,726
|
127,726
|
||||||||||||||||||||||||||
Total
Comprehensive Income (Loss)
|
(23,504,958
|
)
|
127,726
|
(23,377,232
|
)
|
||||||||||||||||||||||||||||||||
Balance
at July 31, 2007
|
-
|
-
|
109,616,518
|
109,616
|
-
|
-
|
247,079,439
|
-
|
(212,000,270
|
)
|
881,807
|
36,070,592
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-25
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
|||||||||||||||
(A
DEVELOPMENT STAGE COMPANY)
|
|||||||||||||||
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
Cumulative
From
|
|
||||||
|
|
|
|
|
|
|
|
November
2, 1995
|
|
||||
|
|
|
|
|
|
|
|
(Date
of Inception)
|
|
||||
|
|
For
the Year Ended July 31,
|
|
to
July 31,
|
|
||||||||
|
|
2007
|
|
2006
|
|
2005
|
|
2007
|
|
||||
Cash
Flows From Operating Activities:
|
|||||||||||||
Net
loss
|
$
|
(23,504,958
|
)
|
$
|
(67,967,204
|
)
|
$
|
(24,001,735
|
)
|
$
|
(209,705,213
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
|||||||||||||
in
operating activities:
|
|||||||||||||
Depreciation
and amortization
|
1,166,090
|
1,134,676
|
1,103,948
|
5,881,946
|
|||||||||
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
|
391,103
|
|||||||||
Write-off
of deferred offering costs
|
—
|
—
|
—
|
3,406,196
|
|||||||||
Write-off
of abandoned patents
|
21,721
|
73,699
|
66,952
|
171,506
|
|||||||||
Loss
on disposal of property and equipment
|
—
|
911
|
—
|
911
|
|||||||||
Loss
on extinguishment of debt
|
237,163
|
12,550,565
|
1,346,341
|
14,134,069
|
|||||||||
Common
stock issued as employee compensation
|
748,076
|
1,545,504
|
—
|
2,293,580
|
|||||||||
Common
stock issued for services rendered
|
1,695,013
|
515,039
|
1,131,452
|
6,996,316
|
|||||||||
Amortization
of prepaid services in conjunction with common stock
issuance
|
—
|
138,375
|
—
|
138,375
|
|||||||||
Non-cash
compensation expense
|
—
|
—
|
—
|
45,390
|
|||||||||
Stock
options and warrants issued for services rendered
|
266,400
|
172,450
|
547,755
|
7,272,723
|
|||||||||
Issuance
of warrants as additional exercise right inducement
|
—
|
21,437,909
|
—
|
21,437,909
|
|||||||||
Preferred
stock issued for services rendered
|
—
|
—
|
—
|
100
|
|||||||||
Treasury
stock redeemed for non-performance of services
|
—
|
—
|
(138,000
|
)
|
(138,000
|
)
|
|||||||
Amortization
of deferred debt issuance costs and loan origination
fees
|
—
|
1,234,772
|
248,107
|
1,482,879
|
|||||||||
Amortization
of discount on convertible debentures
|
608,737
|
14,586,879
|
3,734,811
|
18,930,427
|
|||||||||
Common
stock issued as interest payment on convertible
debentures
|
15,716
|
191,747
|
76,996
|
284,459
|
|||||||||
Interest
on short-term advance
|
—
|
13,524
|
—
|
22,190
|
|||||||||
Founders’
shares transferred for services rendered
|
—
|
—
|
—
|
353,506
|
|||||||||
Fees
in connection with short-term refinancing of
long-term
debt
|
—
|
7,974
|
105,300
|
113,274
|
|||||||||
Changes
in operating assets and liabilities (excluding the effects
of acquisition):
|
|||||||||||||
Accounts
receivable
|
(56,680
|
)
|
—
|
—
|
(56,680
|
)
|
|||||||
Miscellaneous
receivables
|
—
|
—
|
—
|
43,812
|
|||||||||
Inventory
|
(117,502
|
)
|
—
|
—
|
(117,502
|
)
|
|||||||
Other
current assets
|
(26,068
|
)
|
9,596
|
731,656
|
(128,713
|
)
|
|||||||
Accounts
payable and accrued expenses
|
1,682,196
|
3,780,168
|
3,255,169
|
11,328,115
|
|||||||||
Deferred
revenue
|
33,031
|
—
|
—
|
33,031
|
|||||||||
Other,
net
|
—
|
—
|
—
|
110,317
|
|||||||||
Net
Cash Used in Operating Activities
|
(17,231,065
|
)
|
(10,573,416
|
)
|
(11,400,145
|
)
|
(117,888,277
|
)
|
|||||
Cash
Flows From Investing Activities:
|
|||||||||||||
Purchase
of property and equipment
|
(93,704
|
)
|
(149,991
|
)
|
(63,735
|
)
|
(4,536,411
|
)
|
|||||
Costs
incurred for patents
|
(208,606
|
)
|
(114,010
|
)
|
(193,429
|
)
|
(1,817,602
|
)
|
|||||
Change
in restricted cash
|
—
|
216,868
|
19,333
|
45,872
|
|||||||||
Proceeds
from maturity of short term investments
|
22,795,763
|
8,600,000
|
—
|
158,082,809
|
|||||||||
Purchases
of short-term investments
|
(22,434,848
|
)
|
(22,972,653
|
)
|
—
|
(172,094,547
|
)
|
||||||
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
|
(196,457
|
)
|
(29,639
|
)
|
395,889
|
(703,290
|
)
|
||||||
Change
in notes receivable - common stock
|
—
|
—
|
(6,300
|
)
|
(91,103
|
)
|
|||||||
Change
in due from related parties
|
—
|
—
|
—
|
(2,222,390
|
)
|
||||||||
Other,
net
|
—
|
—
|
—
|
89,683
|
|||||||||
Net
Cash Provided by (Used in) Investing Activities
|
(137,852
|
)
|
(14,449,425
|
)
|
151,758
|
(24,322,904
|
)
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-26
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
|
|||||||||||||||
(A
DEVELOPMENT STAGE COMPANY)
|
|||||||||||||||
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
Cumulative
From
|
|
||||||
|
|
|
|
|
|
|
|
November
2, 1995
|
|
||||
|
|
|
|
|
|
|
|
(Date
of Inception)
|
|
||||
|
|
For
the Year Ended July 31,
|
|
to
July 31,
|
|
||||||||
|
|
2007
|
|
2006
|
|
2005
|
|
2007
|
|
||||
Cash
Flows From Financing Activities:
|
|||||||||||||
Proceeds
from short-term advance
|
—
|
—
|
325,179
|
325,179
|
|||||||||
Repayment
of short-term advance
|
—
|
(347,369
|
)
|
—
|
(347,369
|
)
|
|||||||
Proceeds
from issuance of long-term debt
|
—
|
35,461
|
815,832
|
2,005,609
|
|||||||||
Repayment
of long-term debt
|
(73,151
|
)
|
(572,280
|
)
|
(98,447
|
)
|
(1,852,369
|
)
|
|||||
Change
in due to related parties
|
—
|
—
|
—
|
154,541
|
|||||||||
Proceeds
from exercise of warrants
|
125,000
|
39,337,065
|
—
|
44,015,049
|
|||||||||
Proceeds
from exercise of stock options
|
301,931
|
3,241,755
|
—
|
4,554,126
|
|||||||||
Proceeds
from minority interest investment
|
—
|
—
|
—
|
3,038,185
|
|||||||||
Proceeds
from issuance of preferred stock
|
—
|
—
|
—
|
12,015,000
|
|||||||||
Redemption
of SVR preferred stock
|
(100
|
)
|
—
|
—
|
(100
|
)
|
|||||||
Proceeds
from issuance of convertible debentures, net
|
—
|
13,955,000
|
6,299,930
|
20,254,930
|
|||||||||
Repayments
of convertible debentures
|
(174,399
|
)
|
—
|
(461,358
|
)
|
(635,757
|
)
|
||||||
Purchase
of treasury stock
|
—
|
—
|
—
|
(483,869
|
)
|
||||||||
Proceeds
from issuance of common stock, net
|
—
|
7,000,004
|
—
|
80,283,719
|
|||||||||
Purchase
and retirement of common stock
|
—
|
—
|
—
|
(119,066
|
)
|
||||||||
Net
Cash Provided by Financing Activities
|
179,281
|
62,649,636
|
6,881,136
|
163,207,808
|
|||||||||
|
|||||||||||||
Effect
of Exchange Rates on Cash
|
7,210
|
(4,832
|
)
|
3,362
|
29,440
|
||||||||
|
|||||||||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
(17,182,426
|
)
|
37,621,963
|
(4,363,889
|
)
|
21,026,067
|
|||||||
Cash
and Cash Equivalents, Beginning of Period
|
38,208,493
|
586,530
|
4,950,419
|
—
|
|||||||||
Cash
and Cash Equivalents, End of Period
|
$
|
21,026,067
|
$
|
38,208,493
|
$
|
586,530
|
$
|
21,026,067
|
The
Notes
to Consolidated Financial Statements are an integral part of these
statements.
F-27
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
1 - Organization and Business:
Generex
Biotechnology Corporation (the Company) and its wholly-owned subsidiary Generex
Pharmaceuticals, Inc. are engaged in the research and development of drug
delivery systems and technology. Since its inception, the Company has devoted
its efforts and resources to the development of a platform technology for the
oral administration of large molecule drugs, including proteins, peptides,
monoclonal antibodies, hormones and vaccines, which historically have been
administered by injection, either subcutaneously or intravenously. Oral
-lynTM
the
first product based on this platform technology, is in the various stages of
regulatory approval in different jurisdictions around the world.
The
Company’s subsidiary, Antigen Express, Inc. (Antigen), is engaged in research
and development of technologies and immunomedicines for the treatment of
malignant, infectious, autoimmune and allergic diseases. The Company’s
immunomedicine products work by stimulating the immune system to either attack
offending agents (i.e., cancer cells, bacteria, and viruses) or to stop
attacking benign elements (i.e., self proteins and allergens). The
immunomedicine products are based on two platform technologies that were
discovered by an executive officer of Antigen, the Ii-Key hybrid peptides and
Ii-Suppression. These technologies are expected to greatly boost immune cell
responses which diagnose and treat the ailments and conditions.
The
Company is a development stage company, which has a limited history of
operations and whose revenues is primarily comprised of $1 million received
in
conjunction with the execution of a development agreement, grant revenue from
government agencies related to Antigen’s operations and $50,000 in conjunction
with the execution of a licensing agreement (see Note 8). The Company has
realized minimal revenues to date from the sale of its commercial products,
which currently consists of four commercially available products, Glucose
RapidSprayTM.
Additionally, the Company has several product candidates that are in various
research or early stages of pre-clinical and clinical development. There can
be
no assurance that the Company will be successful in obtaining regulatory
clearance for the sale of existing or any future products or that any of the
Company’s products will be commercially viable.
Note
2 - Summary of Significant Accounting Policies
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and all
of
its subsidiaries in which a controlling interest is maintained. For those
consolidated subsidiaries where the Company ownership is less than 100 percent,
the outside stockholders’ interests are shown as minority interests. Effective
December 17, 2004, the Company’s ownership in all consolidated subsidiaries is
100 percent (see Note 12). All significant intercompany transactions and
balances have been eliminated.
Development
Stage Corporation
The
accompanying consolidated financial statements have been prepared in accordance
with the provisions of Statement of Financial Accounting Standard (SFAS) No.
7,
“Accounting and Reporting by Development Stage Enterprises.”
Cash
and Cash Equivalents
The
Company considers all
highly liquid investments purchased with a maturity of three months or less
to
be cash equivalents.
F-28
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Short-Term
Investments
Short-term
investments consist primarily of short-term U.S. term deposits with original
maturities of between three to twelve months. These short-term notes are
classified as held to maturity and are valued at amortized cost. At July 31,
2007, the cost of the investments approximated market value.
Accounts
Receivable
Accounts
receivable are customer obligations due under normal trade terms. The Company
sells its product to various distributors and retailers. The Company performs
ongoing credit evaluations of customers’ financial condition and does not
require collateral.
Management
reviews accounts receivable on a monthly basis to determine collectibility.
Balances that are determined to be uncollectible are written off to the
allowance for doubtful accounts. The allowance for doubtful accounts contains
a
general accrual for estimated bad debts and had a balance of zero at July 31,
2007 and 2006, however, actual write-offs may exceed the allowance.
Inventory
Inventories
consist primarily of Glucose RapidSprayTM
product
and components. Inventories are stated at the lower of cost or market with
cost
determined using the first-in first-out (“FIFO”) method. In evaluating whether
inventory is stated at the lower of cost or market, management considers such
factors as the amount of inventory on hand and in the distribution channel,
estimated time required to sell such inventory, remaining shelf life and current
and expected market conditions, including levels of competition. As appropriate,
a provision is recorded to reduce inventories to their net realizable
value.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation
is provided on the straight-line method over the estimated useful lives of
the
assets, which range from three to thirty years. Gains and losses on depreciable
assets retired or sold are recognized in the statement of operations in the
year
of disposal. Repairs and maintenance expenditures are expensed as
incurred.
Property
Held for Investment
Property
held for investment is recorded at cost less accumulated depreciation.
Depreciation is provided on the straight-line method over the estimated useful
lives of the assets of thirty years. Gains and losses on depreciable assets
retired or sold are recognized in the statement of operations in the year of
disposal. Repairs and maintenance expenditures are expensed as incurred.
Patents
Capitalized
patent costs represent legal costs incurred to establish patents and a portion
of the acquisition price paid attributed to patents upon the acquisition of
Antigen in August 2003. When patents reach a mature stage any associated
legal costs are comprised mostly of maintenance fees and costs of national
applications and are expensed as incurred. Capitalized patent costs are
amortized on a straight line method over the related patent term. As
patents are abandoned, the net book value of the patent is written
off.
F-29
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Impairment
or Disposal of Long-Lived Assets
The
Company assesses the impairment of patents under SFAS No. 144, “Accounting for
the Impairment or Disposal of Long-Lived Assets” whenever events or changes in
circumstances indicate that the carrying value may not be recoverable. For
long-lived assets to be held and used, the Company recognizes an impairment
loss
only if its carrying amount is not recoverable and exceeds its fair value.
The
carrying amount of the long-lived asset is not recoverable if it exceeds the
sum
of the undiscounted cash flows expected to result form the use and eventual
disposal of the asset.
Convertible
Debentures
In
accordance with Emerging Issues Task Force Issue 98-5, Accounting for
Convertible Securities with a Beneficial Conversion Features or Contingently
Adjustable Conversion Ratios ("EITF 98-5"), the Company recognized an imbedded
beneficial conversion feature present in the Convertible Notes. The Company
allocated a portion of the proceeds equal to the intrinsic value of that feature
to additional paid-in capital. The debt discount attributed to the beneficial
conversion feature is amortized over the convertible debenture's maturity period
as interest expense using the effective yield method.
In
accordance with Emerging Issues Task Force Issue 00-27, Application of Issue
No.
98-5 to Certain Convertible Instruments ("EITF 00-27"), the Company recognized
the value attributable to the warrants to additional paid-in capital and a
discount against the convertible debentures. The Company valued the warrants
in
accordance with EITF 00-27 using the Black-Scholes pricing model. The debt
discount attributed to the value of the warrants issued is amortized over the
convertible debenture’s maturity period as interest expense using the effective
yield method.
Revenue
Recognition
Revenues
from the sale of commercial products are recognized at the time title of goods
passes to the buyer and the buyer assumes the risks and rewards of ownership.
Certain product sales are made to retailers under agreements allowing for a
right to return unsold products. In accordance with SFAS No. 48, “Revenue
Recognition When Right of Return Exists (as amended)” recognition of revenue on
all sales to these retailers is deferred until the right of return expires,
the
product is sold to a third party or a provision for returns can be reasonably
estimated based on historical experience. The cost of inventory under these
sales is considered to be a consigned inventory until the revenue is
recognized.
Grant
revenue is recognized as the Company provides the services stipulated in
the underlying grant based on the time and expenditures incurred. Amounts
received in advance of services provided are recorded as deferred revenue and
amortized as revenue when the services are provided.
Included
in miscellaneous income are fees received under licensing agreements.
Nonrefundable fees received under licensing agreements are recognized as revenue
when received if the Company has no continuing obligations to the other
party.
Rental
income is recognized as revenue in the period lease payments are
due.
Research
and Development Costs
Expenditures
for research and development are expensed as incurred and include, among other
costs, those related to the production of experimental drugs, including payroll
costs, and amounts incurred for conducting clinical trials. Amounts expected
to
be received from governments under research and development tax credit
arrangements are offset against current income tax expense.
F-30
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Income
Taxes
Income
taxes are accounted for under the asset and liability method prescribed by
SFAS
No. 109, “Accounting for Income Taxes.”
Deferred income taxes are recorded for temporary differences between financial
statement carrying amounts and the tax basis of assets and liabilities. Deferred
tax assets and liabilities reflect the tax rates expected to be in effect for
the years in which the differences are expected to reverse. A valuation
allowance is provided if it is more likely than not that some or all of the
deferred tax asset will not be realized.
Stock-Based
Compensation
Effective
August 1, 2005, the Company adopted SFAS No. 123(R) which revises SFAS No.
123 “Accounting for Stock-Based Compensation” (“SFAS 123”) and supersedes
Accounting Principles Board Opinion 25 “Accounting for Stock Issued to
Employees.” Under APB 25, the Company used the “intrinsic value” method for
employee stock options and did not record any expense because option exercise
prices equaled the market value at the date of grant. SFAS 123(R) required
that
new, modified and unvested share-based payment transactions with employees,
such
as grants of stock options and restricted stock, be recognized in the financial
statements based on their fair value at the grant date and recognized as
compensation expense over their vesting periods. The Company estimates the
fair
value of stock options as of the date of grant using the Black-Scholes pricing
model and restricted stock based on the quoted market price. The Company adopted
SFAS 123(R) using the modified prospective method and, accordingly, prior period
financial statements were not revised. The Company also follows the guidance
in
EITF 96-18, “Accounting for Equity Instruments That Are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services” for
equity instruments issued to consultants.
Net
Loss Per Common Share
Basic
EPS
is computed by dividing income (loss) available to common stockholders by the
weighted average number of common shares outstanding during the period. Diluted
EPS gives effect to all dilutive potential common shares outstanding during
the
period. The computation of Diluted EPS does not assume conversion, exercise
or
contingent exercise of securities that would have an anti-dilutive effect on
earnings. Refer to Note 15 for methodology for determining net loss per
share.
Comprehensive
Loss
Other
comprehensive income (loss), which includes only foreign currency translation
adjustments, is shown in the Statement of Changes in Stockholders’
Equity.
Concentration
of Credit Risk
The
Company maintains cash balances, at times, with financial institutions in excess
of amounts insured by the Canada Deposit Insurance Corporation and the Federal
Deposit Insurance Corporation. Management monitors the soundness of these
institutions and considers the Company’s risk negligible.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America 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 dates
of
the financial statements and the reported amounts of revenues and expenses
during the reporting periods. Actual results could differ from those
estimates.
F-31
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Foreign
Currency Translation
Foreign
denominated assets and liabilities of the Company are translated into U.S.
dollars at the prevailing exchange rates in effect at the end of the reporting
period. Income statement accounts are translated at a weighted average of
exchange rates which were in effect during the period. Translation adjustments
that arise from translating the foreign subsidiary’s financial statements from
local currency to U.S. currency are recorded in the other comprehensive loss
component of stockholders’ equity.
Financial
Instruments
The
carrying values of cash and cash equivalents, short-term investments, other
current assets, accounts payable and accrued expenses approximate their fair
values due to their short-term nature. Due from related party approximated
its
fair value as it was due on demand. Long-term debt and convertible debentures
approximates their fair value based upon the borrowing rates available for
the
nature of the underlying debt.
Effects
of Recent Accounting Pronouncements
In
September 2006, the FASB issued SFAS No. 157, "Fair Value Measurements" ("SFAS
157"). SFAS 157 defines fair value, establishes a framework for measuring fair
value in accordance with accounting principles generally accepted in the United
States, and expands disclosures about fair value measurements. SFAS No. 157
is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, with earlier application encouraged. Any amounts recognized
upon adoption as a cumulative effect adjustment will be recorded to the opening
balance of retained earnings in the year of adoption. The Company is currently
evaluating the impact of this statement on its results of operations or
financial position of the Company.
In
February 2007, the FASB issued SFAS No. 159, “Establishing the Fair Value Option
for Financial Assets and Liabilities” to permit all entities to choose to elect
to measure eligible financial instruments and certain other items at fair
value. The decision whether to elect the fair value option may occur for
each eligible items either on a specified election date or according to a
preexisting policy for specified types of eligible items. However, that decision
must also take place on a date on which criteria under SFAS 159 occurs.
Finally, the decision to elect the fair value option shall be made on an
instrument-by-instrument basis, except in certain circumstances. An entity
shall report unrealized gains and losses on items for which the fair value
option has been elected in earnings at each subsequent reporting date. SFAS
No.
159 applies to fiscal years beginning after November 15, 2007, with early
adoption permitted for an entity that has also elected to apply the provisions
of SFAS No. 157, Fair
Value Measurements. The
Company is currently evaluating this pronouncement in connection with SFAS
No.
157.
F-32
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
3 - Property and Equipment:
The
costs
and accumulated depreciation of property and equipment are summarized as
follows:
July
31,
|
|||||||
2007
|
|
2006
|
|||||
Land
|
$
|
213,312
|
$
|
201,075
|
|||
Buildings
and Improvements
|
1,352,010
|
1,274,448
|
|||||
Furniture
and Fixtures
|
101,705
|
91,151
|
|||||
Office
Equipment
|
181,273
|
151,684
|
|||||
Lab
Equipment
|
4,221,152
|
4,046,520
|
|||||
Total
Property and Equipment
|
6,069,452
|
5,764,878
|
|||||
Less
Accumulated Depreciation
|
3,932,425
|
3,179,134
|
|||||
Property
and Equipment, Net
|
$
|
2,137,027
|
$
|
2,585,744
|
|||
Depreciation
expense amounted to $631,597, $605,657 and $631,134 for the years
ended
July 31, 2007,
2006
and 2005,
respectively.
|
|||||||
On
August 1, 2005, the Company reclassified certain land and building
and
building improvements classified as property and equipment to property
held for investment. At July 31, 2005, the aggregate cost and related
accumulated depreciation reclassified was as follows:
|
|||||||
Land
|
|
$ |
181,507
|
||||
Buildings
and Improvements
|
|
1,147,093
|
|||||
Total
Property and Equipment Reclassified
|
|
1,328,600
|
|||||
Less
Accumulated Depreciation
|
|
255,851
|
|||||
Property
and Equipment, Net Reclassified
|
|
$
|
1,072,749
|
Such
reclassification had no effect on the consolidated statements of activities
as
previously reported.
Note
4 - Property Held for Investment, Net:
The
costs
and accumulated depreciation of assets held for investment are summarized as
follows:
|
|
July
31,
|
|
||||
|
|
2007
|
|
2006
|
|||
Assets
Held For Investment
|
$
|
4,485,179
|
$
|
4,227,871
|
|||
Less:
Accumulated Depreciation
|
791,996
|
625,098
|
|||||
Assets
Held For Investment, Net
|
$
|
3,693,183
|
$
|
3,602,773
|
Depreciation
expense amounted to $122,171, $125,366 and $73,077 for the years ended July
31,
2007,
2006
and
2005,
respectively.
The
Company’s intent is to hold this properties for investment purposes and collect
rental income. Included in income from rental operations, net is $457,458,
$464,150 and $315,514 of rental income and $179,984, $227,629 and $129,657
of
rental expenses for
the
years ended July 31, 2007, 2006 and 2005, respectively.
On
August
1, 2005, the Company reclassified certain land and building and building
improvements classified as property and equipment to property held for
investment (see Note 3).
F-33
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
5 - Patents:
The
costs
and accumulated amortization of patents are summarized as follows:
July
31,
|
|
||||||
|
|
2007
|
|
2006
|
|||
Patents
|
$
|
6,580,005
|
$
|
6,380,006
|
|||
Less:
Accumulated Amortization
|
1,695,021
|
1,282,179
|
|||||
Patents,
Net
|
$
|
4,884,984
|
$
|
5,097,827
|
|||
Weighted
Average Life
|
13.1
years
|
13.7
years
|
Amortization
expense amounted to $412,322, $403,654 and $399,737 for the years ended July
31,
2007,
2006
and
2005,
respectively. Amortization expense is expected to be approximately $419,000
per
year for the years ended July 31, 2008 through 2012. During the years ended
July
31, 2007,
2006
and
2005,
the
Company wrote off approximately $22,000, $74,000 and $67,000 of net book value
of patents to general and administrative expenses, respectively.
Note
6 - Income Taxes:
The
Company has incurred losses since inception, which have generated net operating
loss carryforwards. The net operating loss carryforwards arise from both United
States and Canadian sources. Pretax losses arising from domestic operations
(United States) were
$19,012,466, $64,252,188 and $20,937,976 for the years ended July 31,
2007,
2006
and
2005,
respectively. Pretax losses arising from foreign operations (Canada and Bermuda)
were $4,492,492, $3,715,016 and $3,063,759 for the years ended July 31,
2007,
2006
and
2005,
respectively. As of July 31, 2007,
the
Company has net operating loss carryforwards in Generex Biotechnology
Corporation of approximately $123,200,000, which expire in 2014 through 2027,
in
Generex Pharmaceuticals Inc. of approximately $31,000,000, which expire in
2008
through 2013 and in Antigen Express, Inc. of approximately $13,300,000, which
expire in 2015 through 2027. These loss carryforwards are subject to limitation
due to the acquisition of Antigen and may be limited in future years should
certain ownership changes occur.
For
the
years ended July 31, 2007,
and
2006,
the
Company’s effective tax rate differs from the federal statutory rate principally
due to net operating losses and other temporary differences for which no benefit
was recorded.
Deferred
income taxes consist of the following:
July
31,
|
|||||||
2007
|
2006
|
||||||
Deferred
Tax Assets:
|
|||||||
Net
operating loss carryforwards
|
$
|
57,628,338
|
$
|
47,811,943
|
|||
Other
timing difference
|
2,579,377
|
2,660,938
|
|||||
Total
Deferred Tax Assets
|
60,207,715
|
50,472,881
|
|||||
Valuation
Allowance
|
(58,873,007
|
)
|
(48,991,563
|
)
|
|||
Deferred
Tax Liabilities
|
|||||||
Intangible
assets
|
(1,236,432
|
)
|
(1,347,468
|
)
|
|||
Other
timing difference
|
(98,276
|
)
|
(133,850
|
)
|
|||
Total
Deferred Tax Liabilities
|
(1,334,708
|
)
|
(1,481,318
|
)
|
|||
Net
Deferred Income Taxes
|
$
|
–
|
$
|
–
|
F-34
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
A
reconciliation of the United States Federal Statutory rate to the Company’s
effective tax rate for the years ended July 31, 2007,
2006
and
2005
is as
follows:
2007
|
2006
|
2005
|
||||||||
Federal
statutory rate
|
(34.0
|
)%
|
(34.0
|
)%
|
(34.0
|
)%
|
||||
Increase
(decrease) in income taxes resulting from:
|
||||||||||
Imputed
interest income on intercompany receivables
|
||||||||||
from
foreign subsidiaries
|
2.0
|
--
|
--
|
|||||||
Nondeductible
items
|
--
|
7.0
|
3.0
|
|||||||
Other
timing differences
|
(10.0
|
)
|
6.0
|
--
|
||||||
Change
in valuation allowance
|
42.0
|
21.0
|
31.0
|
|||||||
Effective
tax rate
|
--
|
%
|
--
|
%
|
--
|
%
|
Note
7 - Accounts Payable and Accrued Expenses:
Accounts
payable and accrued expenses consist of the following:
July
31,
|
|||||||
2007
|
2006
|
||||||
Accounts
Payable
|
$
|
1,791,080
|
$
|
1,214,694
|
|||
Research
and Development
|
1,956,049
|
696,769
|
|||||
Executive
Compensation
|
2,252,978
|
2,121,389
|
|||||
Financial
Services
|
1,156,602
|
1,411,938
|
|||||
Total
|
$
|
7,156,709
|
$
|
5,444,790
|
Note
8 - Commitments and Contingent Liabilities:
Consulting
Agreements
The
Company has entered into a three year non-exclusive consulting agreement
expiring in 2010 with a service provider whereby the service provider will
solicit and evaluate prospective third party wholesale and retail distribution
channels for the Company’s Oral-lynTM.
In
exchange for these services, the Company is required to pay $150,000 per annum
and an aggregate of 450,000 shares of common stock to be issued quarterly over
the term of the agreement.
The
Company has entered into a consulting agreement expiring in December 2007
whereby the consultant will provide various services including sourcing and
evaluating prospective joint ventures, strategic alliances and licensing
arrangements for the Company in respect of the manufacturing, importation,
marketing, distribution and sale of the Company’s products. In exchange for
these services, the Company is required to pay $15,000 per month. The agreement
also requires the payment of bonuses up to $500,000 upon meeting prescribed
milestones. At July 31, 2007, no such milestones have been met. Accordingly,
no
amount has been paid or accrued in the consolidated financial
statements.
F-35
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Leases
The
Company has entered into various operating lease agreements for the use of
operating space, vehicles and office equipment.
Aggregate
minimum annual lease commitments of the Company under non-cancelable operating
leases as of July 31, 2007
are as
follows:
Year
|
Amount
|
|||
2008
|
$
|
148,823
|
||
2009
|
147,355
|
|||
2010
|
108,723
|
|||
2011
|
95,772
|
|||
2012
|
88,040
|
|||
Thereafter
|
497
|
|||
Total
Minimum Lease Payments
|
$
|
589,210
|
Lease
expense amounted to approximately
$41,000, $39,000 and $37,000 for the years ended July 31, 2007,
2006
and
2005,
respectively.
The
preceding data reflects existing leases and does not include replacements upon
their expiration. In the normal course of business, operating leases are
generally renewed or replaced by other leases.
Rental
Operations
The
Company sub-leases a portion of the floor that it owns in an office building
located in Toronto, Canada. The following represents the approximate minimum
amount of sublease income under current lease agreements to be received in
years
ending after July 31, 2007:
Year
|
Amount
|
|||
2008
|
$
|
41,309
|
||
2009
|
36,670
|
|||
2010
|
13,481
|
|||
2011
and thereafter
|
--
|
|||
Total
|
$
|
91,460
|
Property
Held for Investment
The
Company leases two commercial buildings located in Brampton and Mississauga,
Canada, and units of property that it owns located in Toronto, Canada. The
following represents the approximate minimum amount in lease income under
current lease agreements to be received in years ending after July 31,
2007:
Year
|
Amount
|
|||
2008
|
$
|
284,686
|
||
2009
|
194,876
|
|||
2010
|
114,212
|
|||
2011
|
109,459
|
|||
2012
|
94,017
|
|||
Thereafter
|
61,549
|
|||
Total
|
$
|
858,799
|
F-36
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Supply
Agreements
The
Company has a supply agreement with Presspart Manufacturing Limited, whereby
the
Company will purchase its entire requirements for products to use in the
administration of insulin through the buccal mucosa and shall not purchase
the
products or any metal containers competitive to the products from any other
person in exchange for an exclusive non-transferable royalty-free irrevocable
license to use the products. The contract shall continue for a minimum period
of
four contract years from the end of the first contract year in which the total
quantity of products purchased by the Company from Presspart exceeds 10,000,000
units, and thereafter, shall continue until terminated by either party by giving
twelve months written notice.
The
Company has a supply agreement with Catalant Pharma Solutions whereby the
Company will perform a technical transfer for the production of Oral-lyn™ drug
product for use in the Company’s Phase III clinical trials and/or studies. The
anticipated project timeline is seven months and billed over the term of the
project. Either party may terminate the agreement, or any portion thereof,
by
providing forty-five days written notice.
Pending
Litigation
In
February 2001, a former business associate of the former Vice President of
Research and Development (VP) of the Company, and an entity called Centrum
Technologies Inc. (“CTI”) commenced an action in the Ontario Superior Court of
Justice against the Company and the VP seeking, among other things, damages
for
alleged breaches of contract and tortious acts related to a business
relationship between this former associate and the VP that ceased in July 1996.
The plaintiffs’ statement of claim also seeks to enjoin the use, if any, by the
Company of three patents allegedly owned by CTI. On July 20, 2001, the Company
filed a preliminary motion to dismiss the action of CTI as a nonexistent entity
or, alternatively, to stay such action on the grounds of want of authority
of
such entity to commence the action. The plaintiffs brought a cross motion to
amend the statement of claim to substitute Centrum Biotechnologies, Inc. (“CBI”)
for CTI. CBI is a corporation of which 50 percent of the shares are owned by
the
former business associate and the remaining 50 percent are owned by the Company.
Consequently, the shareholders of CBI are in a deadlock. The court granted
the
Company’s motion to dismiss the action of CTI and denied the plaintiffs’ cross
motion without prejudice to the former business associate to seek leave to
bring
a derivative action in the name of or on behalf of CBI. The former business
associate subsequently filed an application with the Ontario Superior Court
of
Justice for an order granting him leave to file an action in the name of and
on
behalf of CBI against the VP and the Company. The Company opposed the
application. In September 2003, the Ontario Superior Court of Justice granted
the request and issued an order giving the former business associate leave
to
file an action in the name of and on behalf of CBI against the VP and the
Company. A statement of claim was served in July 2004. The Company is not able
to predict the ultimate outcome of this legal proceeding at the present time
or
to estimate an amount or range of potential loss, if any, from this legal
proceeding.
F-37
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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.
Employment
Agreements
As
of
July 31, 2007, the Company has an employment agreement with an executive
expiring March 2008, whereby the Company is required to pay an annual base
salary of $300,000. In the event the agreement is terminated, by reason other
than cause, death, voluntary retirement or disability, the Company is required
to pay the employee in one lump sum twelve months base salary and the average
annual bonus.
As
of
July 31, 2007, the Company has an employment agreement with an executive
expiring March 2008, whereby the Company is required to pay an annual base
salary of $200,000. In the event the agreement is terminated, by reason other
than cause, death, voluntary retirement or disability, the Company is required
to pay the employee in one lump sum twelve months base salary and the average
annual bonus.
As
of
July 31, 2007, the Company has employment agreements with its President and
Chief Executive Officer and its Chief Financial Officer and Chief Operating
Officer expiring December 2010, whereby the Company is required to pay an annual
base salary of $500,000 and $400,000, respectively, and bonuses at the
discretion of the Compensation Committee of the Board of Directors. The
agreements require six months notice of non-renewal/ termination. In the event
either agreement is terminated, by reason other than cause, death or disability,
voluntary termination, the Company may be required to pay the executive the
greater of five times base salary or at the date of termination or $5,000,000
in
a combination of cash and common stock of the Company and provide benefits
for a
period of twelve months following the date of termination.
As
of
July 31, 2007, the Company has three at will employment agreements with Antigen
employees requiring the Company to pay an annual aggregate salary of $424,000
to
the three employees. In the event any agreement is terminated by reason other
than death, disability, a voluntary termination not for good reason (as defined
in the agreement) or a termination for cause, the Company is required to pay
the
employee severance in accordance with the terms of the individual employment
agreement.
Termination
Agreements
On
December 17, 2004, the Company and Elan International Services, Ltd. (EIS)
agreed to terminate their joint venture through Generex (Bermuda) Ltd. EIS
has
agreed to transfer all shares of capital stock or Generex (Bermuda) owned by
it
to the Company (see Note 18).
F-38
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Collaboration
Agreements
The
Company has a research and development agreement with Fertin Pharma A/S (Fertin)
whereby the Parties have established collaboration for the development of a
metformin medicinal chewing gum for the treatment of Type-2 diabetes mellitus
and obesity. The agreement includes certain milestone payments required of
the
Company upon Fertin’s completion of various development phases. The Company is
required to pay all development costs related to the development of the product
together with royalty payments amounting to five percent of the sale or
licensing of the products. In lieu of receiving reimbursement for development
costs, Fertin, at its discretion and upon written notice, may elect to receive
royalty payments amounting to twenty-five percent of the sale or licensing
of
the products. The agreement shall remain in effect ten years from the date
of
market introduction and commercial sale. Either party may terminate the
agreement by providing sixty days written notice.
Note
9 - Related Party Transactions:
The
amounts due from a related party at July 31, 2007, 2006 and 2005 were 0, 0
and
379,612, respectively. The amount, which was due from EBI, Inc., is a
shareholder of the Company and is controlled by the estate of the Company’s
former Chairman of the Board. During April 2006, the Company and EBI, Inc.
have
agreed to offset the amount due to the Company in exchange for executive
compensation due to the sole beneficiary of the estate of the Company’s former
Chairman of the Board.
The
Company estimates the following additional amounts would have been recorded
if
such transaction was consummated under arms-length agreements:
For
the Years Ended July 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Interest
Income
|
$
|
--
|
$
|
14,288
|
$
|
15,854
|
The
interest income amounts were computed at estimated prevailing rates based on
the
average receivable balance outstanding during the periods reflected.
The
Company utilizes a management company to manage all of its real estate
properties. The property management company is owned by two of the Company’s
senior officers and the estate of the Company’s former Chairman of the Board.
For the years ended July 31, 2007,
2006
and
2005,
the
Company has paid the management company $47,832, $46,113 and $44,024,
respectively, in management fees.
F-39
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
10 - Long-Term Debt:
Long-term
debt consists of the following:
July
31
|
|||||||
2007
|
2006
|
||||||
Mortgage
payable - interest at 6.822 percent per annum, monthly principal
and
interest payments of $2,194, due June 2011, secured by real property
located at 98 Stafford Drive, Brampton, O
|
|
$
|
273,666
|
|
$
|
264,579
|
|
|
|
|
|
|
|
|
|
Mortgage
payable - interest at 6.822 percent per annum, monthly principal
and
interest payments of $3,538, due June 2011, secured by real property
located at 1740 Sismet Road, Mississauga, ON
|
|
|
441,380
|
|
|
426,725
|
|
|
|
|
|
|
|
|
|
Mortgage
payable - interest at 7.6 percent per annum, monthly payments of
principal
and interest of $5,662, due May 2010, secured by first mortgage
over real
property located at 17 Carlaw Avenue and 33 Harbour Square, Toronto,
Canada
|
|
|
667,943
|
|
|
645,898
|
|
|
|
|
|
|
|
|
|
Mortgage
payable - interest at 10 percent per annum, monthly payments of
principal
and interest of $2,453, due November 2008, secured by real property
located at 13-14, 11 Carlaw Avenue, Toronto, Canada
|
|
|
|
|
|
210,371
|
|
|
|
|
|
|
|
|
|
Mortgage
payable - interest at 8.5 percent per annum, monthly payments of
interest
only of $3,126, principal payment due August 2008, secured by real
property located at 10-11, 11 Carlaw Avenue, Toronto,
Canada
|
|
|
375,120
|
|
|
353,600
|
|
|
|
|
|||||
Mortgage
payable - interest at 6.07 percent per annum, monthly interest
payments of
$8,829, principal due March 2009, secured by secondary rights to
real
property located at 1-8, 11 Carlaw Avenue, Toronto, Canada
|
1,175,309
|
1,139,153
|
|||||
Total
Debt
|
3,143,789
|
3,036,164
|
|||||
Less
Current Maturities of Long-Term Debt
|
84,503
|
428,059
|
|||||
Total
Long-Term Debt
|
$
|
3,059,286
|
$
|
2,608,105
|
Aggregate
maturities of long-term debt of the Company due within the next five years
are
as follows:
Year
|
Amount
|
|||
2008
|
$
|
84,503
|
||
2009
|
1,759,069
|
|||
2010
|
653,691
|
|||
2011
|
646,526
|
|||
2012
and thereafter
|
--
|
|||
Total
|
$
|
3,143,789
|
F-40
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
11 - Convertible Debentures:
As
of
July 31, 2007 and 2006, the Company was contractually obligated under various
convertible promissory notes (“convertible debentures”) with accredited
investors. The convertible debentures were convertible into shares of the
Company's common stock at a price as stipulated in each agreement, required
the
issuance of warrants to the investor in conjunction with the transaction in
accordance with the warrant terms in the individual debenture agreement and
provided a 100% additional investment right (with the exception of the
1st
$500,000, $100,000 and 3rd
$4,000,000 debentures) exercisable for up to twelve months following the
effective date of the registration statement with respect to the
transaction.
The
convertible debentures are accounted for in accordance with EITF 98-5 and 00-27
(see Note 2). The following summarizes the significant terms and accounting
for
each convertible debenture entered into by the Company.
F-41
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Debenture
|
||||||||||
1st
$4,000,000
|
1st
$500,000
|
$100,000
|
||||||||
Date
Issued
|
12/2004
|
|
3/2005
|
4/2005
|
||||||
Promissory
Note Amount
|
$
|
1,000,000
|
$
|
500,000
|
$
|
100,000
|
||||
#
of Promissory Notes
|
4
|
1
|
1
|
|||||||
Terms
|
(A
|
)
|
(E
|
)
|
(E
|
)
|
||||
Conversion
Price
|
$
|
0.82
|
$
|
0.82
|
$
|
0.82
|
||||
Gross
Proceeds
|
$
|
4,000,000
|
$
|
500,000
|
$
|
100,000
|
||||
Issuance
Costs Paid in Cash
|
$
|
300,070
|
$
|
--
|
$
|
--
|
||||
Issuance
Costs Paid in Common Stock
|
$
|
--
|
$
|
--
|
$
|
--
|
||||
Shares
of Common Stock
|
--
|
--
|
--
|
|||||||
Issuance
Costs Paid in Warrants
|
145,000
|
--
|
--
|
|||||||
Warrant
Exercise Price
|
$
|
0.91
|
n/a
|
n/a
|
||||||
Warrant
Fair Value (WFV)
|
$
|
89,900
|
n/a
|
n/a
|
||||||
Black
Scholes Model Assumptions
|
(B1
|
)
|
n/a
|
n/a
|
||||||
Total
Issuance Costs (C)
|
$
|
389,970
|
$
|
--
|
$
|
--
|
||||
Amortization
of Issuance Costs as
|
||||||||||
Non-cash
Interest Expense
|
$
|
389,970
|
$
|
--
|
$
|
--
|
||||
Net
Cash Proceeds
|
$
|
3,699,930
|
$
|
500,000
|
$
|
100,000
|
||||
Warrants
Issued to Investor
|
4,878,048
|
1,219,512
|
243,902
|
|||||||
Warrant
Exercise Price
|
$
|
0.91
|
$
|
0.82
|
$
|
0.82
|
||||
Warrant
Fair Value (WFV)
|
$
|
1,722,222
|
$
|
245,521
|
$
|
49,104
|
||||
Black
Scholes Model Assumptions
|
(B1
|
)
|
(B2
|
)
|
(B2
|
)
|
||||
Beneficial
Conversion Feature (BCF)
|
$
|
1,722,222
|
$
|
86,984
|
$
|
17,397
|
||||
Amortization
of WFV and BCF as
|
||||||||||
Non-cash
Interest Expense
|
$
|
3,444,444
|
$
|
332,505
|
$
|
66,501
|
||||
Principal
and Interest Converted
|
$
|
1,628,292
|
$
|
528,082
|
$
|
105,644
|
||||
Loss
on Extinguishment (D)
|
$
|
42,409
|
$
|
--
|
$
|
--
|
||||
Shares
Issued Upon Conversion
|
1,985,249
|
644,003
|
128,834
|
|||||||
Principal
and Interest Repayments
|
||||||||||
in
Shares of Common Stock
|
$
|
2,005,500
|
$
|
--
|
$
|
--
|
||||
Loss
on Extinguishment (D)
|
$
|
147,457
|
$
|
--
|
$
|
--
|
||||
Shares
Issued for Principal and
|
||||||||||
Interest
Repayments
|
3,158,344
|
--
|
--
|
|||||||
Principal
and Interest Repayments
|
||||||||||
in
Cash
|
$
|
506,564
|
$
|
--
|
$
|
--
|
||||
Warrant
Issued to Investor for 1st
|
||||||||||
Extension
of Maturity Date (F)
|
n/a
|
1,219,512
|
243,902
|
|||||||
Warrant
Exercise Price
|
n/a
|
$
|
0.82
|
$
|
0.82
|
|||||
Warrant
Fair Value (WFV)
|
n/a
|
$
|
597,561
|
$
|
119,512
|
|||||
Black
Scholes Model Assumptions
|
n/a
|
(B2
|
)
|
(B2
|
)
|
|||||
Warrant
Issued to Investor for 2nd
|
||||||||||
Extension
of Maturity Date (F)
|
n/a
|
1,219,512
|
243,902
|
|||||||
Warrant
Exercise Price
|
n/a
|
$
|
0.82
|
$
|
0.82
|
|||||
Warrant
Fair Value (WFV)
|
n/a
|
$
|
524,390
|
$
|
104,878
|
|||||
Black
Scholes Model Assumptions
|
n/a
|
(B7
|
)
|
(B7
|
)
|
F-42
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Debenture
|
||||||||||
1st
2,000,000
|
2nd
2,000,000
|
2nd
$500,000
|
||||||||
Date
Issued
|
6/2005
|
9/2005
|
10/2005
|
|||||||
Promissory
Note Amount
|
$
|
500,000
|
$
|
500,000
|
$
|
500,000
|
||||
#
of Promissory Notes
|
4
|
4
|
1
|
|||||||
Terms
|
(A
|
)
|
(A
|
)
|
(A
|
)
|
||||
Conversion
Price
|
$
|
0.60
|
$
|
0.60
|
0.82
|
|||||
Gross
Proceeds
|
$
|
2,000,000
|
$
|
2,000,000
|
$
|
500,000
|
||||
Issuance
Costs Paid in Cash
|
$
|
--
|
$
|
15,000
|
$
|
--
|
||||
Issuance
Costs Paid in Common Stock
|
$
|
140,000
|
$
|
140,000
|
$
|
33,250
|
||||
Shares
of Common Stock
|
170,732
|
170,732
|
35,000
|
|||||||
Issuance
Costs Paid in Warrants
|
35,000
|
60,000
|
15,000
|
|||||||
Warrant
Exercise Price
|
$
|
0.82
|
$
|
0.82
|
$
|
0.95
|
||||
Warrant
Fair Value (WFV)
|
$
|
20,300
|
$
|
30,600
|
$
|
14,250
|
||||
Black
Scholes Model Assumptions
|
(B3
|
)
|
(B4
|
)
|
(B4
|
)
|
||||
Total
Issuance Costs (C)
|
$
|
160,300
|
$
|
185,600
|
$
|
47,500
|
||||
Amortization
of Issuance Costs as
|
||||||||||
Non-cash
Interest Expense
|
$
|
160,300
|
$
|
185,600
|
$
|
47,500
|
||||
Net
Cash Proceeds
|
$
|
2,000,000
|
$
|
1,985,000
|
$
|
500,000
|
||||
Warrants
Issued to Investor
|
2,439,024
|
2,439,024
|
609,756
|
|||||||
Warrant
Exercise Price
|
$
|
0.82
|
$
|
0.82
|
$
|
0.82
|
||||
Warrant
Fair Value (WFV)
|
$
|
828,571
|
$
|
785,185
|
$
|
270,950
|
||||
Black
Scholes Model Assumptions
|
(B3
|
)
|
(B4
|
)
|
(B4
|
)
|
||||
Beneficial
Conversion Feature (BCF)
|
$
|
1,171,429
|
$
|
1,185,185
|
$
|
229,050
|
||||
Amortization
of WFV and BCF as
|
||||||||||
Non-cash
Interest Expense
|
$
|
2,000,000
|
$
|
1,970,370
|
$
|
500,000
|
||||
Principal
and Interest Converted
|
$
|
1,800,206
|
$
|
1,729,144
|
$
|
385,769
|
||||
Loss
on Extinguishment (D)
|
$
|
--
|
$
|
1,088,868
|
$
|
1,180,830
|
||||
Shares
Issued Upon Conversion
|
3,000,344
|
2,878,648
|
470,450
|
|||||||
Principal
and Interest Repayments
|
||||||||||
in
Shares of Common Stock
|
$
|
225,322
|
$
|
293,893
|
$
|
125,244
|
||||
Loss
on Extinguishment (D)
|
$
|
62,242
|
$
|
394,912
|
$
|
93,361
|
||||
Shares
Issued for Principal and
|
||||||||||
Interest
Repayments
|
407,075
|
489,822
|
152,736
|
|||||||
Principal
and Interest Repayments
|
||||||||||
in
Cash
|
$
|
--
|
$
|
--
|
$
|
--
|
F-43
GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Debenture
|
||||||||||
$3,500,000
|
2nd
$4,000,000
|
3rd
$4,000,000
|
||||||||
Date
Issued
|
12/2005
|
1/2006
|
2/2006
|
|||||||
Promissory
Note Amount
|
$
|
1,000,000
|
$
|
1,000,000
|
$
|
1,000,000
|
||||
#
of Promissory Notes
|
3.5
|
4
|
4
|
|||||||
Terms
|
(A
|
)
|
(A
|
)
|
(A
|
)
|
||||
Conversion
Price
|
$
|
0.82
|
$
|
1.05
|
$
|
1.25
|
||||
Gross
Proceeds
|
$
|
3,500,000
|
$
|
4,000,000
|
$
|
4,000,000
|
||||
Issuance
Costs Paid in Cash
|
$
|
15,000
|
$
|
15,000
|
$
|
--
|
||||
Issuance
Costs Paid in Common
|
||||||||||
Stock
|
$
|
179,550
|
$
|
266,400
|
$
|
--
|
||||
Shares
of Common Stock
|
189,000
|
266,667
|
--
|
|||||||
Issuance
Costs Paid in Warrants
|
105,000
|
120,000
|
--
|
|||||||
Warrant
Exercise Price
|
$
|
0.82
|
$
|
1.05
|
n/a
|
|||||
Warrant
Fair Value (WFV)
|
$
|
76,650
|
$
|
88,800
|
n/a
|
|||||
Black
Scholes Model Assumptions
|
(B5
|
)
|
(B6
|
)
|
n/a
|
|||||
Total
Issuance Costs (C)
|
$
|
271,200
|
$
|
370,200
|
$
|
--
|
||||
Amortization
of Issuance Costs as
|
||||||||||
Non-cash
Interest Expense
|
$
|
271,200
|
$
|
370,200
|
$
|
--
|
||||
Net
Cash Proceeds
|
$
|
3,485,000
|
$
|
3,985,000
|
$
|
4,000,000
|
||||
Warrants
Issued to Investor
|
4,268,292
|
3,809,524
|
3,200,000
|
|||||||
Warrant
Exercise Price
|
$
|
0.82
|
$
|
1.05
|
$
|
1.25
|
||||
Warrant
Fair Value (WFV)
|
$
|
1,648,387
|
$
|
1,653,631
|
$
|
2,374,507
|
||||
Black
Scholes Model Assumptions
|
(B5
|
)
|
(B6
|
)
|
(B7
|
)
|
||||
Beneficial
Conversion Feature (BCF)
|
$
|
1,851,613
|
$
|
1,463,155
|
$
|
1,625,493
|
||||
Amortization
of WFV and BCF as
|
||||||||||
Non-cash
Interest Expense
|
$
|
3,500,000
|
$
|
3,116,786
|
$
|
4,000,000
|
||||
Principal
and Interest Converted
|
$
|
3,435,735
|
$
|
3,635,041
|
$
|
3,081,556
|
||||
Loss
on Extinguishment (D)
|
$
|
1,473,115
|
$
|
4,558,356
|
$
|
2,450,301
|
||||
Shares
Issued Upon Conversion
|
4,189,923
|
3,461,946
|
2,448,764
|
|||||||
Principal
and Interest Repayments
|
||||||||||
in
Shares of Common Stock
|
$
|
86,475
|
$
|
398,578
|
$
|
941,326
|
||||
Loss
on Extinguishment (D)
|
$
|
176,556
|
$
|
541,854
|
$
|
571,782
|
||||
Shares
Issued for Principal and
|
||||||||||
Interest
Repayments
|
105,456
|
381,709
|
641,813
|
|||||||
Principal
and Interest Repayments
|
||||||||||
in
Cash
|
$
|
--
|
$
|
--
|
$
|
174,399
|
As
of
July 31, 2007, all convertible debentures have either been repaid or converted
to shares of common stock and the related debt discounts have been fully
amortized.
As
of
July 31, 2006, the $160,494 net outstanding balance of convertible debentures
was comprised of $769,231 of debt net of unamortized debt discount of $608,737
related to the 3rd
$4,000,000 convertible debentures. All other convertible debentures had either
been repaid or converted to shares of common stock and the related debt
discounts had been fully amortized.
F-44
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(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.
|
Black
Scholes pricing model assumptions:
|
|
Risk
Free
Interest Rate |
|
Expected
Volatility |
|
Life
(Years)
|
||||
(B1)
|
1.79%
|
1.0463
|
5.50
|
|||||||
(B2)
|
2.78%
|
1.0054
|
5.50
|
|||||||
(B3)
|
3.02%
|
0.9775
|
5.50
|
|||||||
(B4)
|
3.76%
|
0.9232
|
5.50
|
|||||||
(B5)
|
4.02%
|
0.9288
|
5.50
|
|||||||
(B6)
|
4.23%
|
0.9210
|
5.50
|
|||||||
(B7)
|
4.49%
|
0.9380
|
5.50
|
(C) |
The
issuance cost is amortized over the life of the debt as a deferred
debt
issuance cost.
|
(D) |
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.
|
(E) |
The
notes carry a 10% coupon and a 1 ½ month term. The principal and interest
payments are payable in cash or, at the Holder's option, in common
stock
at a per share price equal to
$0.82.
|
(F) |
The
Company extended the maturity date of the convertible debenture from
May
to July and later to September 2005. In consideration for the holder’s
agreement to extend the maturity date, the Company issued the holder
additional warrants. In accordance with EITF 98-5, the fair value
of the
warrants was determined to be the reacquisition price on the debt
extinguishment date and was recorded as a loss on
extinguishment.
|
Note
12 - Series A Preferred Stock:
During
2001, the Company issued 1,000 shares of Series A Preferred Stock (Series A)
with a par value of $.001 per share. The holder had the right at any time after
January 16, 2004 to convert Series A shares into shares of common stock of
the
Company as well as the option to exchange the shares of the Company’s Series A
Preferred stock for shares of the Company’s convertible preferred shares of
Generex (Bermuda), Ltd. Holders of Series A shares were not entitled to vote.
In
addition, the holders of Series A shares were entitled to receive a dividend
per
share equal to the dividend declared and paid on shares of the Company’s common
stock as and when dividends are declared and paid on the Company’s common stock,
and were also entitled to receive a mandatory annual dividend equal to 6 percent
per year on the original issue price of $12,015 per share.
In
December 2004, the holder of the Series A Preferred Stock sold its holdings
to a
third party. In conjunction with sale, all of the Company’s outstanding Series A
Preferred Stock was automatically converted to common stock. As a result, the
buyer received 534,085 shares of common stock and the Company no longer has
any
outstanding shares of Series A Preferred Stock (see Note 18).
F-45
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
13 - Stockholders’ Equity:
Warrants
As
of
July 31, 2007,
the
Company has the following warrants to purchase common stock
outstanding:
Number
of Shares
|
Warrant
Exercise
|
Warrant
|
|||||
To
be Purchased
|
Price
Per Share
|
Expiration
Date
|
|||||
|
|||||||
5,000
|
|
$
|
2.50
|
|
November
29, 2007
|
||
30,000
|
$
|
3.00
|
November
29, 2007
|
||||
500,000
|
$
|
2.50
|
January
15, 2008
|
||||
255,102
|
$
|
1.86
|
January
9, 2009
|
||||
57,143
|
$
|
2.20
|
January
9, 2009
|
||||
13,889
|
$
|
2.25
|
January
9, 2009
|
||||
166,667
|
$
|
1.89
|
February
13, 2009
|
||||
17,169
|
$
|
2.10
|
February
13, 2009
|
||||
327,869
|
$
|
1.68
|
July
12, 2009
|
||||
500,000
|
$
|
1.09
|
August
10, 2009
|
||||
100,000
|
$
|
0.82
|
April
27, 2010
|
||||
102,232
|
$
|
1.25
|
April
17, 2011
|
||||
70,000
|
$
|
2.66
|
April
17, 2011
|
||||
25,000
|
$
|
1.91
|
May
29, 2011
|
||||
3,273,144
|
$
|
2.35
|
May
31, 2011
|
||||
2,560,980
|
$
|
2.45
|
May
31, 2011
|
||||
5,000
|
$
|
1.05
|
July
19, 2011
|
||||
622,226
|
$
|
1.60
|
July
22, 2011
|
||||
4,770,617
|
$
|
3.00
|
August
26, 2011
|
||||
172,120
|
$
|
1.25
|
August
27, 2011
|
||||
800,000
|
$
|
3.00
|
September
2, 2011
|
||||
100,000
|
$
|
1.71
|
March
3, 2012
|
||||
140,000
|
$
|
1.45
|
May
27, 2012
|
||||
14,614,158
|
|
F-46
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Notes
Receivable - Common Stock
Notes
receivable - common stock consist of two separate promissory notes. The first
promissory note was issued in conjunction with the redemption of Series A
Redeemable Common Stock Purchase Warrants in June 1999, and was for $50,000.
This note was originally due on December 1, 1999. After multiple extensions,
the
note together with accrued interest at 7 percent per annum, was due July 31,
2004. In January 2005, the Company deemed this note as uncollectible and,
therefore, has taken a charge to general and administrative expenses for the
outstanding principal and accrued interest in the amount of $72,107. This charge
is included in operations for the year ended July 31, 2005.
The
second promissory note was issued in conjunction with the exercise of 50,000
Common Stock Options in March 2001, and was for $250,000. This note was
originally due on March 15, 2002. After multiple extensions, the note together
with accrued interest at 7 percent per annum was due March 15, 2004. In January
2005, the Company deemed this note as uncollectible and, therefore, has taken
a
charge to general and administrative expenses for the outstanding principal
and
accrued interest in the amount of $318,996. This charge is included in
operations for the year ended July 31, 2005.
Preferred
Stock
The
Company has authorized 1,000,000 shares of preferred stock with a par value
of
one-tenth of a cent ($.001) per share. The preferred stock may be issued in
various series and shall have preference as to dividends and to liquidation
of
the Company. The Company’s Board of Directors is authorized to establish the
specific rights, preferences, voting privileges and restrictions of such
preferred stock, or any series thereof. At July 31, 2007 and 2006, no shares
of
preferred stock were issued or outstanding.
Special
Voting Rights Preferred Stock
In
1997,
the Company issued 1,000 shares of Special Voting Rights Preferred Stock (SVR
Shares) with a par value of $.001. The Company had the right at any time after
December 31, 2000, upon written notice to all holders of preferred shares,
to
redeem SVR Shares at $.10 per share. Holders of SVR Shares were not entitled
to
vote, except as specifically required by applicable law or in the event of
change in control, as defined. In addition, holders of SVR Shares were entitled
to receive a dividend per share equal to the dividend declared and paid on
shares of the Company’s common stock as and when dividends are declared and paid
on the Company’s common stock. During the year ended July 31, 2007, the Company
redeemed and cancelled 1,000 shares of Special Voting Rights Preferred Stock
for
$100. This redemption represented all issued and outstanding
shares.
Equity
Instruments Issued for Services Rendered
During
the years ended July 31, 2007,
2006
and
2005,
the
Company issued stock options, warrants and shares of common stock in exchange
for services rendered to the Company. The fair value of each stock option and
warrant was valued using the Black Scholes pricing model which takes into
account as of the grant date the exercise price and expected life of the stock
option or warrant, the current price of the underlying stock and its expected
volatility, expected dividends on the stock and the risk free interest rate
for
the term of the stock option or warrant. Shares of common stock are valued
at
the quoted market price on the date of grant. The fair value of each grant
was
charged to the related expense in the statement of operations for the services
received.
F-47
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
14 - Stock Based Compensation:
Stock
Option Plans
As
of
July 31, 2007, the Company had three stockholder-approved stock incentive plans
under which shares and options exercisable for shares of common stock have
been
or may be granted to employees, directors, consultants and advisors. A total
of
2,000,000 shares of common stock are reserved for issuance under the 2000 Stock
Option Plan (the 2000 Plan), a total of 12,000,000 shares of common stock are
reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan) and
10,000,000 shares of common stock are reserved for issuance under the 2006
Stock
Plan (the 2006 Plan). Restricted shares can only be issued under the 2006 Plan.
At July 31, 2007, there were 1,940,000, 1,182,490 and 9,108,000 shares of common
stock reserved for future awards under the 2000 Plan, 2001 Plan and 2006 Plan,
respectively.
The
2000,
2001 and 2006 Plans (the Plans) are administered by the Board of Directors
(the
Board). The Board is authorized to select from among eligible employees,
directors, advisors and consultants those individuals to whom options are to
be
granted and to determine the number of shares to be subject to, and the terms
and conditions of the options. The Board is also authorized to prescribe, amend
and rescind terms relating to options granted under the Plans. Generally, the
interpretation and construction of any provision of the Plans or any options
granted hereunder is within the discretion of the Board.
The
Plans
provide that options may or may not be Incentive Stock Options (ISOs) within
the
meaning of Section 422 of the Internal Revenue Code. Only employees of the
Company are eligible to receive ISOs, while employees and non-employee
directors, advisors and consultants are eligible to receive options which are
not ISOs, i.e. “Non-Qualified Options.” The options granted by the Board in
connection with its adoption of the Plans are Non-Qualified Options. In
addition, the 2006 Plan also provides for restricted stock grants.
Effective
August 1, 2005, the Company implemented the fair value recognition provisions
of
SFAS 123(R) and SAB 107 for all share-based compensation. Share-based
employee compensation related to stock options for the years ended July 31,
2007
and 2006 amounted to $-0- (net of related tax) for each year and is included
in
the statements of operations. Share-based employee compensation related to
common stock grants for the years ended July 31, 2007 and 2006 amounted to
$748,076 and $1,545,504, respectively, and is included in the statements of
operations.
The
fair
value of each option granted is estimated on grant date using the Black-Scholes
option pricing model which takes into account as of the grant date the exercise
price and expected life of the option, the current price of the underlying
stock
and its expected volatility, expected dividends on the stock and the risk-free
interest rate for the term of the option. The following is the average of the
data used to calculate the fair value:
Risk-Free
|
Expected
|
Expected
|
Expected
|
||||||||||
Interest
Rate
|
Life
(Years)
|
Volatility
|
Dividends
|
||||||||||
July
31, 2007 and 2006
|
n/a
|
|
n/a
|
n/a
|
n/a
|
||||||||
July
31, 2005
|
2.32%
|
5.00
|
1.0215
|
--
|
F-48
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
THE
FOLLOWING IS A SUMMARY OF THE
COMMON
STOCK OPTIONS GRANTED,
FORFEITED
OR EXPIRED AND
EXERCISED
UNDER THE
PLAN
Weighted
Average
|
|
||||||
|
|
|
|
Exercise
Price
|
|
||
|
|
Options
|
Per
Share
|
||||
Outstanding
- August 1, 2004
|
7,214,159
|
$
|
3.49
|
||||
Granted
|
6,046,110
|
$
|
0.50
|
||||
Forfeited
or expired
|
(1,653,000
|
)
|
$
|
6.49
|
|||
Exercised
|
--
|
$
|
--
|
||||
Outstanding
- July 31, 2005
|
11,607,269
|
$
|
1.51
|
||||
Granted
|
--
|
$
|
--
|
||||
Forfeited
or expired
|
(755,000
|
)
|
$
|
5.97
|
|||
Exercised
|
(2,352,672
|
)
|
$
|
1.37
|
|||
Outstanding
- July 31, 2006
|
8,499,597
|
$
|
1.15
|
||||
Granted
|
--
|
$
|
--
|
||||
Forfeited
or expired
|
(250,159
|
)
|
$
|
7.86
|
|||
Exercised
|
(286,800
|
)
|
$
|
1.05
|
|||
Outstanding
- July 31, 2007
|
7,962,638
|
$
|
1.12
|
||||
Exercisable
- July 31, 2007
|
7,962,638
|
$
|
1.12
|
Options
typically vest over a period of two years and have a contractual life of five
years.
The
Company had no non-vested stock options outstanding as of July 31, 2007.
Accordingly, there was no unrecognized compensation related to non-vested stock
options granted under the Company’s stock option plans.
F-49
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Options
Outstanding
|
|||||||||||||
Weighted
|
|||||||||||||
Number
|
Weighted
|
Average
|
|||||||||||
Outstanding
|
Average
|
Remaining
|
Aggregate
|
||||||||||
Range
of
|
at
|
Exercise
|
Life
|
Intrinsic
|
|||||||||
Exercise
Price
|
July
31, 2007
|
Price
|
(Years)
|
Value
|
|||||||||
$0.001
|
2,239,610
|
$
|
0.001
|
2.68
|
|||||||||
$0.56
- $0.94
|
2,702,528
|
0.77
|
2.39
|
||||||||||
$1.00
- $2.19
|
3,020,500
|
1.80
|
0.73
|
||||||||||
7,962,638
|
1.84
|
$
|
6,059,852
|
Options
Exercisable
|
||||||||||
Number
|
Weighted
|
|||||||||
Outstanding
|
Average
|
Aggregate
|
||||||||
Range
of
|
at
|
Exercise
|
Intrinsic
|
|||||||
Exercise
Price
|
July
31, 2007
|
Price
|
Value
|
|||||||
$0.001
|
|
2,239,610
|
$
|
0.001
|
|
|||||
$0.56
- $0.94
|
2,702,528
|
0.77
|
||||||||
$1.00
- $2.19
|
3,020,500
|
1.80
|
||||||||
7,962,638
|
|
$
|
6,059,852
|
For
the Year Ended July 31,
|
||||||||||
2007
|
2006
|
2005
|
||||||||
Weighted
Average Grant Date Fair Value of Options Granted
|
$
|
--
|
$
|
--
|
$
|
0.59
|
||||
Aggregate
Intrinsic Value of Options Exercised
|
$
|
238,179
|
$
|
3,499,814
|
$
|
--
|
||||
Cash
Received for Exercise of Stock Options
|
$
|
301,932
|
$
|
3,241,755
|
$
|
--
|
During
the year ended July 31, 2005 the Company issued 2,239,610 options at an exercise
price of $0.001 as settlement for outstanding executive compensation.
Accordingly, the Company has included a charge for the fair value of these
options in the amount of $1,332,052 in the statement of operations. No gain
or
loss was recorded as a result of this transaction.
The
intrinsic value is calculated as the difference between the market value as
of
July 31, 2007 and the exercise price of the shares. The market value as of
July
31, 2007 was $1.60 as reported by the NASDAQ Stock Market.
F-50
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The
following table illustrates the pro forma effect on net income and earnings
per
share for the year ended July 31, 2005, assuming the Company had applied the
fair value recognition provisions of SFAS 123(R) to all previously granted
share-based awards after giving consideration to potential forfeitures during
such periods.
Year
Ended
|
||||
July
31,
|
||||
2005
|
||||
Net
Loss Available to Common
|
||||
Stockholders,
as Reported
|
$
|
(24,001,735
|
)
|
|
Add:
Total Stock-Based Employee
|
||||
Compensation
Expense Included
|
||||
In
Reported Net Loss
|
--
|
|||
Deduct:
Total Stock-Based Employee
|
||||
Compensation
Expense Determined
|
||||
Under
Fair Value Based Method
|
2,199,300
|
|||
Pro
Forma Net Loss Available
|
||||
to
Common Stockholders
|
$
|
(26,201,035
|
)
|
|
Loss
Per Share:
|
||||
Basic
and diluted, as reported
|
$
|
(0.66
|
)
|
|
Basic
and diluted, pro forma
|
$
|
(0.72
|
)
|
Note
15 - Net Loss Per Share:
Basic
earnings per shares (EPS) and Diluted EPS for the years ended July 31,
2007,
2006
and 2005
have been computed by dividing the net loss available to common stockholders
for
each respective period by the weighted average shares outstanding during that
period. All outstanding warrants, options and shares to be issued upon
conversion of the outstanding convertible debentures, representing approximately
22,576,796, 24,455,964 and 35,291,316 incremental shares, have been excluded
from the 2007,
2006
and 2005
computation of Diluted EPS as they are antidilutive due to the losses
generated.
Note
16 - Supplemental Disclosure of Cash Flow Information:
For
the Years Ended July 31,
|
||||||||||
2007
|
|
2006
|
|
2005
|
||||||
Cash
paid during the year for:
|
||||||||||
Interest
|
$
|
256,836
|
$
|
273,097
|
$
|
184,655
|
||||
Income
taxes
|
$
|
--
|
$
|
--
|
$
|
--
|
Disclosure
of non-cash investing and financing activities:
Year
Ended July 31, 2007
|
||||
Principal
repayment of convertible debentures through the issuance
|
||||
of
common stock
|
$
|
384,616
|
||
Issuance
of common stock in conjunction with convertible debenture
|
||||
conversion
|
$
|
210,216
|
||
Par
value in connection with voluntary relinquishment and cancellation
|
||||
of
150,000 shares of common stock
|
$
|
150
|
F-51
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Year
Ended July 31, 2006
|
||||
Value
of common stock issued in conjunction with capitalized
|
||||
services
upon issuance of convertible debentures
|
$
|
619,467
|
||
Value
of warrants issued in conjunction with capitalized
|
||||
services
upon issuance of convertible debentures
|
$
|
210,300
|
||
Costs
paid from proceeds in conjunction with capitalized
services
|
||||
upon
issuance of convertible debentures
|
$
|
45,000
|
||
Value
of warrants issued in conjunction with issuance of
convertible
|
||||
debentures
and related beneficial conversion feature
|
$
|
13,087,156
|
||
Satisfaction
of accounts payable through the issuance of common
|
||||
stock
|
$
|
391,147
|
||
Principal
repayment of convertible debentures through the issuance
|
||||
of
common stock
|
$
|
2,102,689
|
||
Issuance
of common stock in conjunction with convertible debenture
|
||||
conversion
|
$
|
14,551,466
|
||
Increase
in other current assets for the prepayment of services
|
||||
through
the issuance of common stock
|
$
|
184,500
|
||
Satisfaction
of due from related party through reduction of accrued
|
||||
executive
compensation
|
$
|
415,828
|
||
Repayment
of long-term debt through the issuance of long-term debt
|
||||
upon
refinancing
|
$
|
1,082,443
|
Year
Ended July 31, 2005
|
||||
Costs
associated with convertible debentures paid from proceeds
|
$
|
300,070
|
||
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
|
$
|
110,200
|
||
Sale
of Series A Preferred Stock and mandatorily converted
|
||||
to
common shares
|
$
|
14,310,057
|
||
Value
of warrants issued in conjunction with issuance of
|
||||
convertible
debentures and related beneficial conversion feature
|
$
|
5,843,450
|
||
Satisfaction
of accounts payable through the issuance of
|
||||
common
stock
|
$
|
1,526,326
|
||
Principal
repayment of convertible debentures through the
|
||||
issuance
of common stock
|
$
|
1,235,577
|
||
Issuance
of common stock in conjunction with convertible
|
||||
debenture
conversions
|
$
|
1,479,500
|
||
Issuance
of below market stock options in satisfaction of
|
||||
accounts
payable and accrued expenses
|
$
|
1,332,052
|
||
Costs
paid from proceeds of issuance of long-term debt
|
$
|
54,466
|
||
Repayment
of long-term debt through the issuance of long-term debt
|
||||
upon
refinancing
|
$
|
323,301
|
F-52
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Note
17 - Segment Information:
The
Company follows SFAS No. 131, “Disclosures about Segments of an Enterprise and
Related Information” (SFAS No. 131). SFAS No. 131 establishes standards for the
way that public business enterprises report information about operating segments
in annual financial statements and requires that those enterprises report
selected information about operating segments in interim financial reports.
SFAS
No. 131 also establishes standards for related disclosures about products and
services, geographic areas, and major customers.
SFAS
No.
131 uses a management approach for determining segments. The management approach
designates the internal organization that is used by management for making
operating decisions and assessing performance as the source of the Company’s
reportable segments. The Company’s management reporting structure provides for
only one segment.
The
regions in which the Company had identifiable assets and revenues are presented
in the following table. Identifiable assets are those that can be directly
associated with a geographic area.
2007
|
2006
|
2005
|
||||||||
Identifiable
Assets
|
||||||||||
Canada
|
$
|
41,899,734
|
$
|
59,583,574
|
$
|
8,722,630
|
||||
United
States
|
4,504,670
|
4,521,668
|
4,743,215
|
|||||||
Total
|
$
|
46,404,404
|
$
|
64,105,242
|
$
|
13,465,845
|
||||
Revenue
|
||||||||||
Canada
|
$
|
25,242
|
$
|
--
|
$
|
--
|
||||
United
States
|
157,187
|
175,000
|
392,112
|
|||||||
Total
|
$
|
182,429
|
$
|
175,000
|
$
|
392,112
|
Note
18 - Collaborative Agreements:
The
Company has a research and development agreement with Fertin Pharma A/S (Fertin)
whereby the Parties have established collaboration for the development of a
metformin medicinal chewing gum for the treatment of Type-2 diabetes mellitus
and obesity. (See Note 8)
The
Company has a collaboration agreement with Stallergenes, S.A., a European firm
in immunological treatments and asthma. Through the collaboration the parties
agreed to pursue the design and test of li-key/allergen epitope hybid pepticles
to create a novel approach for the control of both dangerous forms of asthma
and
functionally disabling allergic reactions.
The
Company had a joint venture with Elan International Services, Ltd. (“EIS”), a
wholly owned subsidiary of Elan Corporation, plc (EIS and Elan Corporation,
plc
being collectively referred to as “Elan”). The parties conducted the joint
venture through Generex (Bermuda), Ltd. (Generex Bermuda), a Bermuda limited
liability company.
F-53
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The
Company applied the $12,015,000 that it received from Elan for the shares of
the
Company’s Series A Preferred Stock (see Note 12) to form Generex Bermuda. The
Company’s interest in this company consisted of 6,000 shares of Generex Bermuda
common stock and 3,612 shares of convertible preferred stock, representing
an
80.1 percent equity ownership interest in Generex Bermuda. At the same time,
Elan remitted $2,985,000 to purchase 2,388 shares of Generex Bermuda convertible
preferred stock, representing a 19.9 percent equity ownership interest in
Generex Bermuda. The Series A Preferred stock had an exchange feature which
allowed Elan to acquire an additional 30.1 percent equity ownership interest
in
Generex Bermuda. As of July 31, 2007,
2006
and
2005,
the
minority interest has been reduced to $-0- due to their share of Generex
Bermuda’s net loss.
On
December 17, 2004, the Company entered into a Termination Agreement with Elan.
In connection with negotiating the Termination Agreement, Elan approached the
Company for consent to transfer the Series A Preferred Stock by way of an
auction process. The Company responded to Elan request by delivering a proposal
letter describing the terms and conditions pursuant to which the Company would
consent to the transfer of the Series A Preferred Stock (the Proposal). The
Proposal required that (i) the auction process conclude no later than December
15, 2004 and the Elan’s disposition of the shares conclude no later than
December 31, 2004 (the Closing Date), (ii) the buyer immediately convert the
preferred stock at the voluntary conversion price of $25.77 (calculated pursuant
to the terms of the certificate of designation for the preferred stock resulting
in the issuance of 534,085 shares of common stock), (iii) Elan’s registration
rights may not be transferred, and (iv) for a period of two (2) years after
the
Closing Date, the purchaser of the Series A Preferred Stock may not transfer
the
shares of common stock issuable upon conversion thereof of the Company shall
have the right to redeem the shares of common stock at a per share price of
150
percent of the average closing price of the common stock on the Nasdaq SmallCap
Market for the twenty (20) days immediately preceding the Closing
Date.
Subsequently,
the purchaser of the Series A Preferred Stock converted all outstanding shares
into 534,085 shares of common stock of the Company and, the Company no longer
has any outstanding shares of Series A Preferred Stock. (See Note
12)
Note
19 - Quarterly Information (Unaudited):
The
following schedule sets forth certain unaudited financial data for the preceding
eight quarters ending July 31, 2007.
In our
opinion, the unaudited information set forth below has been prepared on the
same
basis as the audited information and includes all adjustments necessary to
present fairly the information set forth herein. The operating results for
the
quarter are not indicative of results for any future period.
Q1
|
Q2
|
Q3
|
Q4
|
||||||||||
Fiscal
Year July 31, 2007:
|
|||||||||||||
Revenues
|
$
|
139,005
|
$
|
45,421
|
$
|
10,960
|
$
|
(15,188
|
)
|
||||
Operating
loss
|
$
|
(3,980,182
|
)
|
$
|
(5,478,477
|
)
|
$
|
(8,006,072
|
)
|
$
|
(7,411,371
|
)
|
|
Net
loss
|
$
|
(3,658,045
|
)
|
$
|
(5,195,634
|
)
|
$
|
(7,718,355
|
)
|
$
|
(6,932,924
|
)
|
|
Net
loss available to common
|
|||||||||||||
stockholders
|
$
|
(3,658,045
|
)
|
$
|
(5,195,634
|
)
|
$
|
(7,718,355
|
)
|
$
|
(6,932,924
|
)
|
|
Net
loss per share
|
$
|
(0.03
|
)
|
$
|
(0.05
|
)
|
$
|
(0.07
|
)
|
$
|
(0.07
|
)
|
F-54
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Fiscal
Year July 31, 2006:
|
|||||||||||||
Contract
research revenue
|
$
|
43,750
|
$
|
43,750
|
$
|
43,750
|
$
|
43,750
|
|||||
Operating
loss
|
$
|
(2,107,485
|
)
|
$
|
(5,184,252
|
)
|
$
|
(3,890,499
|
)
|
$
|
(7,523,747
|
)
|
|
Net
loss
|
$
|
(9,003,218
|
)
|
$
|
(14,400,597
|
)
|
$
|
(31,773,494
|
)
|
$
|
(12,789,895
|
)
|
|
Net
loss available to common
|
|||||||||||||
stockholders
|
$
|
(9,003,218
|
)
|
$
|
(14,400,597
|
)
|
$
|
(31,773,494
|
)
|
$
|
(12,789,895
|
)
|
|
Net
loss per share
|
$
|
(.20
|
)
|
$
|
(.22
|
)
|
$
|
(.36
|
)
|
$
|
(.12
|
)
|
Note
20 - Subsequent Events:
During
August 2007, the Company issued an aggregate of 550,000 shares of common stock
value at $1.51 to three executives of the Company under the 2006 Stock Plan,
of
which 312,500 shares were unrestricted and issued for past services to the
Company. Accordingly, the Company has included the value of these shares in
the
consolidated financial statements for the year ended July 31, 2007. The
remaining 237,500 shares are restricted for a period ranging from one to two
years. Accordingly, the value of the restricted shares will be measured at
the
grant date at $1.51 and amortized over their respective restriction periods.
In
addition, the Company retroactively awarded the same executives salary increases
amounting to approximately $179,000 in the aggregate. Accordingly, the Company
has included this amount in the consolidated financial statements for the year
ended July 31, 2007.
During
August 2007, the Company issued an aggregate of 100,000 unrestricted shares
of
common stock valued at $1.51 to a director of the Company.
During
September 2007, the Company issued an aggregate of 50,000 restricted shares
of
common stock valued at $1.53 to a financial consultant.
F-55
Item
9. Changes
in and Disagreements With Accountants on Accounting and Financial
Disclosure.
None.
Item
9A. Controls
and Procedures.
Evaluation
of Disclosure Controls and Procedures
Prior
to
the filing of this Report on Form 10-K, 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 Report on Form 10-K, 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 SEC rules and forms and is
accumulated and communicated to the Company’s management, as appropriate, to
allow timely decisions regarding required disclosure.
Changes
in Internal Control over Financial Reporting
There
were no changes during the fiscal quarter ended July 31, 2007 in our internal
control over financial reporting that materially affected, or are reasonably
likely to materially affect, those controls.
MANAGEMENT’S
REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
The
management of Generex Biotechnology Corporation (the “Company”) is responsible
for establishing and maintaining adequate internal control over financial
reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities
Exchange Act of 1934, as amended. The Company’s internal control over financial
reporting is designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles. The
Company’s internal control over financial reporting includes those policies and
procedures that:
(i)
pertain to the maintenance of records that, in reasonable detail, accurately
and
fairly reflect the transactions and dispositions of the assets of the Company;
(ii)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with U.S. generally
accepted accounting principles, and that receipts and expenditures of the
Company are being made only in accordance with authorizations of management
and
directors of the Company; and
(iii)
provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the Company’s assets that could
have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
The
Company’s management assessed the effectiveness of the Company’s internal
control over financial reporting as of July 31, 2007. In making this assessment,
management used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in Internal Control-Integrated
Framework. Based on management’s assessment using those criteria, management has
concluded that the Company’s internal control over financial reporting was
effective as of July 31, 2007.
45
Danziger
Hochman Partners LLP, the independent registered public accounting firm that
audited the financial statements that appear in the Company’s Annual Report on
Form 10-K for the year ended July 31, 2007, has issued an attestation report
on
the Company’s internal control over financial reporting as of July 31, 2007,
which is included in Part
II, Item
8 - Financial Statements and Supplementary Data
of this
Annual Report on Form 10-K..
Item
9B. Other
Information.
Reference
is made to the disclosure set forth under the caption Sales
of Unregistered Securities
in Item
5 of this Annual Report on Form 10-K, which is incorporated by reference
herein.
PART
III
Item
10. Directors,
Executive Officers and Corporate Governance.
The
information required by this Item is incorporated by reference from the Proxy
Statement, or an amendment to this Annual Report on Form 10-K, to be filed
with
the Commission not later than 120 days after the end of the fiscal year to
which
this report relates.
Information
with respect to our Executive Officers appears in Part I of this report.
We
have
adopted a Code of Ethics and Business Conduct that applies to our President
and
Chief Executive Officer, our Chief Financial Officer and Chief Operating
Officer, any Vice-President, Controller, Secretary, Treasurer and any other
personnel performing similar functions. A copy of this Code of Ethics is posted
on our Internet website, which is www.generex.com.
Item
11. Executive
Compensation.
The
information required by this Item is incorporated by reference from the Proxy
Statement, or an amendment to this Annual Report on Form 10-K, to be filed
with
the Commission not later than 120 days after the end of the fiscal year to
which
this report relates.
Item
12. Security
Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters.
The
information required by this Item is incorporated by reference from the Proxy
Statement, or an amendment to this Annual Report on Form 10-K, to be filed
with
the Commission not later than 120 days after the end of the fiscal year to
which
this report relates.
Item
13. Certain
Relationships and Related Transactions, and Director
Independence.
The
information required by this Item is incorporated by reference from the Proxy
Statement, or an amendment to this Annual Report on Form 10-K, to be filed
with
the Commission not later than 120 days after the end of the fiscal year to
which
this report relates.
Item
14. Principal
Accounting Fees and Services.
The
information required by this Item is incorporated by reference from the Proxy
Statement, or an amendment to this Annual Report on Form 10-K, to be filed
with
the Commission not later than 120 days after the end of the fiscal year to
which
this report relates.
46
PART
IV
Item.
15 Exhibits
and Financial Statements and Schedules.
(a) 1. Financial
Statements - See Part
II - Item 8. Financial Statements and Supplementary Data
hereof
on page 44.
The
financial statements include the following:
Consolidated
Balance Sheets as of July 31, 2007 and 2006
Consolidated
Statements of Operations for the Year Ended July 31, 2007, 2006 and 2005 and
Cumulative from Inception to July 31, 2007
Consolidated
Statements of Changes in Stockholders’ Equity for the Period November 2, 1995
(Date of Inception) to July 31, 2007
Consolidated
Statements of Cash Flows for the Years Ended July 31, 2007, 2006 and 2005 and
Cumulative from Inception to July 31, 2007
2. Financial
Statement Schedule and Auditor’s Report
Schedule
I - Condensed financial information of registrant
This
schedule is not applicable.
Schedule
II - Valuation and qualifying accounts
See
Schedule II on page 56.
3. 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)
|
47
4.2.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|
|
|
4.2.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|
|
|
4.2.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
4.3
|
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to
Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|
|
|
4.4.1
|
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.2
|
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.3
|
|
Form
of Warrant issued in connection with Exhibit 4.4.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.4.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
|
|
4.5.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.3
|
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.5.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
48
4.6.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.8.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.3
|
|
Warrant
issued in connection with Exhibit 4.9.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
49
4.9.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.10.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.10.3
|
|
Form
of Warrant issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.10.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.11.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
4.11.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.4
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
4.12
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|
|
|
4.13.1
|
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
|
|
|
4.13.2
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
|
|
|
4.14
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|
|
|
4.15.1
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.2
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
50
4.15.3
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.4
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
|
|
4.15.5
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.16.1
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.2
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.3
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.4
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.5
|
|
Form
of Additional AIR Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.16.6
|
|
Form
of Additional AIR Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.17.1
|
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
|
|
|
4.17.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
|
|
|
|
4.18
|
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006)
|
|
|
|
4.19
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
|
51
4.20.1
|
|
Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
|
|
|
|
4.20.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
|
|
|
|
4.21.1
|
|
Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
|
|
|
|
4.21.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.39 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
|
|
|
9
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
10.1
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Mindy J. Allport-Settle to purchase 100,000 shares of Common Stock
at the
exercise price of $0.56 per share (incorporated by reference to Exhibit
10.2 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q
filed on June 14, 2005)*
|
|
10.2
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Peter G. Amanatides to purchase 100,000 shares of Common Stock at
the
exercise price of $0.56 per share (incorporated by reference to Exhibit
10.3 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q
filed on June 14, 2005)*
|
|
|
|
10.3
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and John
P. Barratt to purchase 100,000 shares of Common Stock at the exercise
price of $0.56 per share (incorporated by reference to Exhibit 10.4
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.4
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Brian T. McGee to purchase 100,000 shares of Common Stock at the
exercise
price of $0.56 per share (incorporated by reference to Exhibit 10.5
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.5
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and John
P. Barratt to purchase 35,714 shares of Common Stock at the exercise
price
of $0.001 per share (incorporated by reference to Exhibit 10.6 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
|
|
|
|
10.6
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Brian T. McGee to purchase 35,714 shares of Common Stock at the exercise
price of $0.001 per share (incorporated by reference to Exhibit 10.7
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.7
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Gerald Bernstein, M.D. to purchase 100,000 shares of Common Stock
at the
exercise price of $0.61 per share (incorporated by reference to Exhibit
10.8 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q
filed on June 14, 2005)*
|
52
10.8
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Mark
Fletcher to purchase 250,000 shares of Common Stock at the exercise
price
of $0.61 per share (incorporated by reference to Exhibit 10.9 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
|
|
|
|
10.9
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Anna
E. Gluskin to purchase 250,000 shares of Common Stock at the exercise
price of $0.61 per share (incorporated by reference to Exhibit 10.10
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.10
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Rose
C. Perri to purchase 250,000 shares of Common Stock at the exercise
price
of $0.61 per share (incorporated by reference to Exhibit 10.11 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
|
|
|
|
10.11
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Mark
A. Fletcher to purchase 470,726 shares of Common Stock at the exercise
price of $0.001 per share (incorporated by reference to Exhibit 10.12
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.12
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Anna
E. Gluskin to purchase 1,120,704 shares of Common Stock at the exercise
price of $0.001 per share (incorporated by reference to Exhibit 10.13
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.13
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Rose
C. Perri to purchase 576,752 shares of Common Stock at the exercise
price
of $0.001 per share (incorporated by reference to Exhibit 10.14 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
|
|
|
|
10.14
|
|
Employment
Agreement by and between Generex Biotechnology Corporation and Gerald
Bernstein M.D. (incorporated by reference to Exhibit 10.16 to Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
|
|
|
|
10.15
|
|
1998
Stock Option Plan (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Registration Statement on Form S-1 (File No.
333-82667) filed on July 12, 1999)*
|
|
|
|
10.16
|
|
2000
Stock Option Plan (incorporated by reference to Exhibit 4.3.2 to
Generex
Biotechnology Corporation’s Annual Report on Form 10-K filed on October
30, 2000)*
|
|
|
|
10.17
|
|
Amended
2001 Stock Option Plan (incorporated by reference to Exhibit 4.1
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
December 15, 2003)*
|
|
|
|
10.18
|
|
2006
Stock Plan (incorporated by reference to Annex A to Generex Biotechnology
Corporation’s Proxy Statement for the Annual Meeting of Stockholders held
on May 30, 2006)*
|
10.19
|
|
Stockholders
Agreement among Generex Biotechnology Corporation and the former
holders
of capital stock of Antigen Express, Inc. (incorporated by reference
to
Exhibit 10.4 to Generex Biotechnology Corporation’s Annual Report on Form
10-K filed on October 29, 2003)
|
53
10.20
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006)*
|
|
|
|
10.21
|
|
Quotation
for Contract Manufacturing of Oral-lyn™ entered into between Generex
Biotechnology Corporation and Cardinal Health PTS, LLC on June 20,
2006
(subject to confidential treatment) (incorporated by reference to
Exhibit
10.25 to Generex Biotechnology Corporation’s Report on Form 10-K/A filed
on February 14, 2007)
|
|
|
|
10.22
|
|
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)
|
|
|
|
10.23
|
|
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)
|
10.24
|
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)*
|
|
|
|
|
10.25
|
Form
of Restricted Stock Agreement for awards to executive officers of
Generex
Biotechnology Corporation under the Generex Biotechnology Corporation
2006
Stock Plan (incorporated by reference to Exhibit 10.1 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)*
|
|
10.26
|
Summary
of Annual Base Salaries of Executive Officers of Generex Biotechnology
Corporation (incorporated by reference to Exhibit 10.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)*
|
|
10.27
|
Summary
of Compensation of the Directors of Generex Biotechnology
Corporation*
|
|
21
|
|
Subsidiaries
of the Registrant
|
|
|
|
23.1
|
|
Consent
of Danziger Hochman Partners LLP, independent registered public accounting
firm
|
|
|
|
23.2
|
|
Consent
of BDO Consent of BDO Dunwoody, LLP, independent registered public
accounting firm
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
32
|
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002
|
*
Management contract or management compensatory plan or arrangement.
|
||
(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.
|
54
Signatures
Pursuant
to the requirements of Section 13 or 15(d) 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 this 15th day of October 2007.
|
|
|
|
GENEREX
BIOTECHNOLOGY CORPORATION
|
|
|
|
|
By:
|
/s/
Anna E. Gluskin
|
|
|
Name:
Anna
E. Gluskin
|
|
|
Title:
Chief
Executive Officer and President
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has
been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
Name
|
|
Capacity
in Which Signed
|
|
Date
|
|
|
|
|
|
/s/
Anna E. Gluskin
Anna
E. Gluskin
|
|
President,
Chief Executive Officer and Director
(Principal Executive Officer) |
|
October
15, 2007
|
|
|
|
|
|
/s/
Rose C. Perri
Rose
C. Perri
|
|
Chief
Operating Officer, Chief Financial Officer, Treasurer, Secretary
and
Director
(Principal Financial and Accounting Officer) |
|
October
15, 2007
|
|
|
|
|
|
/s/
Gerald Bernstein, M.D.
Gerald
Bernstein, M.D.
|
|
Vice
President Medical Affairs and Director
|
|
October
15, 2007
|
|
|
|
|
|
/s/
Brian T. McGee
Brian
T. McGee
|
|
Director
|
|
October
15, 2007
|
|
|
|
|
|
/s/
John P. Barratt
John
P. Barratt
|
|
Director
|
|
October
15, 2007
|
|
|
|
|
|
/s/
Peter G. Amanatides
Peter
G. Amanatides
|
|
Director
|
|
October
15, 2007
|
|
|
|
|
|
/s/
Nola E. Masterson
Nola
E. Masterson
|
|
Director
|
|
October
15, 2007
|
|
|
|
|
|
/s/
Slava Jarnitskii
Slava
Jarnitskii
|
|
Controller
|
|
October
15, 2007
|
55
Schedule
II
SCHEDULE
II
Balance
at
|
Additions
|
Balance
|
||||||||||||||
Beginning
|
Charged
|
Other
|
at
End of
|
|||||||||||||
Of
Period
|
to
Expenses
|
Additions
|
Deductions
|
Period
|
||||||||||||
|
||||||||||||||||
Year
Ended July 31, 2005 Valuation Allowance on Deferred Tax
Asset
|
$
|
27,443,257
|
—
|
—
|
7,506,943
|
$
|
34,950,200
|
|||||||||
Year
Ended July 31, 2006 Valuation Allowance on Deferred Tax
Asset
|
$
|
34,950,200
|
—
|
—
|
14,041,363
|
$
|
48,991,563
|
|||||||||
Year
Ended July 31, 2007 Valuation Allowance on Deferred Tax
Asset
|
$
|
48,991,563
|
—
|
—
|
9,881,444
|
$
|
58,873,007
|
56
EXHIBIT
INDEX
Exhibit
Number
|
Description of Exhibit(1) | |
2
|
|
Agreement
and Plan of Merger among Generex Biotechnology Corporation, Antigen
Express, Inc. and AGEXP Acquisition Inc. (incorporated by reference
to
Exhibit 2.1 to Generex Biotechnology Corporation’s Current Report on Form
8-K filed on August 15, 2003)
|
|
|
|
3(i)
|
|
Restated
Certificate of Incorporation of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 3(II) to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on June 19,
2006)
|
|
|
|
3(ii)
|
|
Bylaws
of Generex Biotechnology Corporation (incorporated by reference to
Exhibit
3.2 to Generex Biotechnology Corporation’s Registration Statement on Form
S-1 (File No. 333-82667) filed on July 12, 1999)
|
|
|
|
4.1
|
|
Form
of Common Stock Certificate (incorporated by reference to Exhibit
4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
4.2.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|
|
|
4.2.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|
|
|
4.2.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
4.3
|
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to
Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|
|
|
4.4.1
|
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.2
|
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|
|
|
4.4.3
|
|
Form
of Warrant issued in connection with Exhibit 4.4.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
4.4.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.4.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|
|
|
4.5.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.5.3
|
|
Warrant
issued in connection with Exhibit 4.5.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.5.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|
|
|
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.7.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
4.8.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.8.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.9.3
|
|
Warrant
issued in connection with Exhibit 4.9.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|
|
|
4.9.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|
|
|
4.10.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.10.3
|
|
Form
of Warrant issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|
|
|
4.10.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.10.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|
|
|
4.11.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|
|
|
4.11.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|
|
|
4.11.4
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
4.12
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|
|
|
4.13.1
|
|
Amendment
No. 4 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto on January 19, 2006
(incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 20,
2006)
|
|
|
|
4.13.2
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated
by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s
Report on Form 8-K filed on January 20, 2006)
|
|
|
|
4.14
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
|
|
|
4.15.1
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.2
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.3
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|
|
|
4.15.4
|
|
Agreement
to Amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|
|
|
4.15.5
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on February
27,
2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.16.1
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Cranshire Capital, L.P. dated February 28, 2006
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.2
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Omicron Master Trust dated February 28, 2006 (incorporated
by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.3
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated
by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on March 1, 2006).
|
|
|
|
4.16.4
|
|
Agreement
to Amend Additional Investment Right between Generex Biotechnology
Corporation and Smithfield Fiduciary LLC dated February 28, 2006
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1, 2006).
|
4.16.5
|
|
Form
of Additional AIR Debenture issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.16.6
|
|
Form
of Additional AIR Warrant issued by Generex Biotechnology Corporation
on
February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex
Biotechnology Corporation’s Report on Form 10-K filed on October 16,
2006)
|
|
|
|
4.17.1
|
|
Form
of Agreement to Amend Warrants between Generex Biotechnology Corporation
and the Investors dated March 6, 2006 (incorporated by reference
to
Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 7, 2006).
|
|
|
|
4.17.2
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on March 6,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 7,
2006)
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|
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4.18
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|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006)
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|
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4.19
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006).
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|
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4.20.1
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Securities
Purchase Agreement entered into by and between Generex Biotechnology
Corporation and four Investors on June 1, 2006 (incorporated by reference
to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on June 2, 2006)
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|
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4.20.2
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|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on June 2, 2006)
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|
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4.21.1
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Form
of Amendment to Outstanding Warrants (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
June 2, 2006)
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|
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4.21.2
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|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.39 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
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9
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Form
of Voting Agreement entered into in connection with Exhibit 4.11.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
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10.1
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Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Mindy J. Allport-Settle to purchase 100,000 shares of Common Stock
at the
exercise price of $0.56 per share (incorporated by reference to Exhibit
10.2 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q
filed on June 14, 2005)*
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10.2
|
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Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Peter G. Amanatides to purchase 100,000 shares of Common Stock at
the
exercise price of $0.56 per share (incorporated by reference to Exhibit
10.3 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q
filed on June 14, 2005)*
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10.3
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and John
P. Barratt to purchase 100,000 shares of Common Stock at the exercise
price of $0.56 per share (incorporated by reference to Exhibit 10.4
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
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|
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10.4
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Brian T. McGee to purchase 100,000 shares of Common Stock at the
exercise
price of $0.56 per share (incorporated by reference to Exhibit 10.5
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
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|
|
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10.5
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and John
P. Barratt to purchase 35,714 shares of Common Stock at the exercise
price
of $0.001 per share (incorporated by reference to Exhibit 10.6 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
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|
|
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10.6
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Brian T. McGee to purchase 35,714 shares of Common Stock at the exercise
price of $0.001 per share (incorporated by reference to Exhibit 10.7
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
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10.7
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and
Gerald Bernstein, M.D. to purchase 100,000 shares of Common Stock
at the
exercise price of $0.61 per share (incorporated by reference to Exhibit
10.8 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q
filed on June 14, 2005)*
|
|
|
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10.8
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Mark
Fletcher to purchase 250,000 shares of Common Stock at the exercise
price
of $0.61 per share (incorporated by reference to Exhibit 10.9 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
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|
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10.9
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Anna
E. Gluskin to purchase 250,000 shares of Common Stock at the exercise
price of $0.61 per share (incorporated by reference to Exhibit 10.10
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.10
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Rose
C. Perri to purchase 250,000 shares of Common Stock at the exercise
price
of $0.61 per share (incorporated by reference to Exhibit 10.11 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
|
|
|
|
10.11
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Mark
A. Fletcher to purchase 470,726 shares of Common Stock at the exercise
price of $0.001 per share (incorporated by reference to Exhibit 10.12
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.12
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Anna
E. Gluskin to purchase 1,120,704 shares of Common Stock at the exercise
price of $0.001 per share (incorporated by reference to Exhibit 10.13
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
June 14, 2005)*
|
|
|
|
10.13
|
|
Stock
Option Agreement by and between Generex Biotechnology Corporation
and Rose
C. Perri to purchase 576,752 shares of Common Stock at the exercise
price
of $0.001 per share (incorporated by reference to Exhibit 10.14 to
Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
|
10.14
|
|
Employment
Agreement by and between Generex Biotechnology Corporation and Gerald
Bernstein M.D. (incorporated by reference to Exhibit 10.16 to Generex
Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June
14, 2005)*
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|
|
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10.15
|
|
1998
Stock Option Plan (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Registration Statement on Form S-1 (File No.
333-82667) filed on July 12, 1999)*
|
|
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|
10.16
|
|
2000
Stock Option Plan (incorporated by reference to Exhibit 4.3.2 to
Generex
Biotechnology Corporation’s Annual Report on Form 10-K filed on October
30, 2000)*
|
|
|
|
10.17
|
|
Amended
2001 Stock Option Plan (incorporated by reference to Exhibit 4.1
to
Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on
December 15, 2003)*
|
|
|
|
10.18
|
|
2006
Stock Plan (incorporated by reference to Annex A to Generex Biotechnology
Corporation’s Proxy Statement for the Annual Meeting of Stockholders held
on May 30, 2006)*
|
10.19
|
|
Stockholders
Agreement among Generex Biotechnology Corporation and the former
holders
of capital stock of Antigen Express, Inc. (incorporated by reference
to
Exhibit 10.4 to Generex Biotechnology Corporation’s Annual Report on Form
10-K filed on October 29, 2003)
|
|
|
|
10.20
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees (incorporated by reference to Exhibit 4.34 to
Generex
Biotechnology Corporation’s Report on Form 10-Q filed on June 14,
2006)*
|
|
|
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10.21
|
|
Quotation
for Contract Manufacturing of Oral-lyn™ entered into between Generex
Biotechnology Corporation and Cardinal Health PTS, LLC on June 20,
2006
(subject to confidential treatment) (incorporated by reference to
Exhibit
10.25 to Generex Biotechnology Corporation’s Report on Form 10-K/A filed
on February 14, 2007)
|
|
|
|
10.22
|
|
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)
|
|
|
|
10.23
|
|
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)
|
10.24
|
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)*
|
|
|
|
|
10.25
|
Form
of Restricted Stock Agreement for awards to executive officers of
Generex
Biotechnology Corporation under the Generex Biotechnology Corporation
2006
Stock Plan (incorporated by reference to Exhibit 10.1 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)*
|
|
10.26
|
Summary
of Annual Base Salaries of Executive Officers of Generex Biotechnology
Corporation (incorporated by reference to Exhibit 10.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on August 23,
2007)*
|
10.27
|
Summary
of Compensation of the Directors of Generex Biotechnology
Corporation*
|
|
21
|
|
Subsidiaries
of the Registrant
|
|
|
|
23.1
|
|
Consent
of Danziger Hochman Partners LLP, independent registered public accounting
firm
|
|
|
|
23.2
|
|
Consent
of BDO Consent of BDO Dunwoody, LLP, independent registered public
accounting firm
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|
|
|
32
|
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002
|
*
Management contract or management compensatory plan or arrangement.
|
||
(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.
|