GENEREX BIOTECHNOLOGY CORP - Quarter Report: 2006 April (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT OF 1934
For
the
quarterly period ended April 30, 2006
o
TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE
ACT OF 1934
For
the transition period from_________________ to
________________
COMMISSION
FILE NUMBER: 0-25169
GENEREX
BIOTECHNOLOGY CORPORATION
(Exact
name of registrant as specified in its charter)
|
Delaware
|
|
98-0178636
|
|
|
(State
of other jurisdiction of incorporation or
organization)
|
|
(IRS
Employer Identification No.)
|
|
33
HARBOUR SQUARE, SUITE 202
TORONTO,
ONTARIO
CANADA
M5J 2G2
(Address
of principal executive offices)
416/364-2551
Not
applicable
(Former
name, former address and former fiscal year
if
changed since last report)
Indicate
by check mark whether the registrant: (1) has filed all reports required by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for the
past
90 days. xYes oNo
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨ Accelerated
filer ¨ Non-accelerated
filer x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). o
Yes
x
No
APPLICABLE
ONLY TO CORPORATE ISSUERS
The
number of outstanding shares of the registrant's common stock, par value $.001,
was 98,495,931 as of June 2, 2006.
GENEREX
BIOTECHNOLOGY CORPORATION
INDEX
PART
I. FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial
Statements.
|
1
|
|
|
(Unaudited)
|
|
Consolidated
Balance Sheets -
|
|
April
30, 2006 and July 31, 2005
|
1
|
|
|
Consolidated
Statements of Operations -- for the three and nine month
|
|
periods
ended April 30, 2006 and 2005, and cumulative from
|
|
November
2, 1995 to April 30, 2006
|
2
|
|
|
Consolidated
Statements of Cash Flows -- For the nine month
|
|
periods
ended April 30, 2006 and 2005, and cumulative from
|
|
November
2, 1995 to April 30, 2006
|
3
|
|
|
Notes
to Consolidated Financial Statements
|
4
|
|
|
Item
2. Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
26
|
|
|
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
|
45
|
|
|
Item
4. Controls
and Procedures
|
45
|
|
|
PART
II: OTHER INFORMATION
|
|
|
|
Item
1. Legal
Proceedings
|
46
|
|
|
Item
1A. Risk
Factors
|
46
|
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds
|
51
|
|
|
Item
3. Defaults
Upon Senior Securities
|
53
|
|
|
Item
4. Submission
of Matters to a Vote of Security Holders
|
53
|
|
|
Item
5. Other
Information
|
53
|
|
|
Item
6. Exhibits
|
54
|
|
|
Signatures
|
61
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
GENEREX
BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIES
|
||||||||||
(A
DEVELOPMENT STAGE COMPANY)
|
||||||||||
CONSOLIDATED
BALANCE SHEETS
|
||||||||||
April
30,
|
July
31,
|
|||||||||
2006
|
2005
|
|||||||||
ASSETS | ||||||||||
Current
Assets:
|
||||||||||
Cash
and cash equivalents
|
$
|
31,183,186
|
$
|
586,530
|
||||||
Restricted
cash
|
--
|
204,734
|
||||||||
Short-term
investments
|
10,773,605
|
--
|
||||||||
Other
current assets
|
174,840
|
165,586
|
||||||||
Deferred
debt issuance costs
|
36,888
|
337,798
|
||||||||
Total
Current Assets
|
42,168,519
|
1,294,648
|
||||||||
Property
and Equipment, Net
|
2,700,051
|
3,976,742
|
||||||||
Assets
Held for Investment, Net
|
3,680,815
|
2,371,749
|
||||||||
Patents,
Net
|
5,198,612
|
5,443,094
|
||||||||
Due
From Related Party
|
--
|
379,612
|
||||||||
TOTAL
ASSETS
|
$
|
53,747,997
|
$
|
13,465,845
|
||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||||
Current
Liabilities:
|
||||||||||
Accounts
payable and accrued expenses
|
$
|
2,846,411
|
$
|
2,410,846
|
||||||
Short-term
advance
|
--
|
325,179
|
||||||||
Current
maturities of long-term debt
|
2,022,840
|
2,571,530
|
||||||||
Convertible
Debentures, Net of Debt Discount of $1,119,923 and
|
||||||||||
$2,108,459
at April 30, 2006 and July 31, 2005, respectively
|
253,154
|
1,314,926
|
||||||||
Total
Current Liabilities
|
5,122,405
|
6,622,481
|
||||||||
Long-Term
Debt, Net
|
1,331,182
|
716,361
|
||||||||
Commitments
and Contingencies
|
||||||||||
Stockholders’
Equity:
|
||||||||||
Special
Voting Rights Preferred stock, $.001 par value;
|
||||||||||
authorized,
issued and outstanding 1,000 shares at
|
||||||||||
April
30, 2006 and July 31, 2005, respectively
|
1
|
1
|
||||||||
Common
stock, $.001 par value; authorized 150,000,000 shares at
|
||||||||||
April
30, 2006 and July 31, 2005; 98,242,854 and 41,933,898
|
||||||||||
shares
issued and outstanding, respectively
|
98,242
|
41,935
|
||||||||
Additional
paid-in capital
|
222,120,021
|
126,044,326
|
||||||||
Deficit
accumulated during the development stage
|
(175,705,417
|
)
|
(120,528,108
|
)
|
||||||
Accumulated
other comprehensive income
|
781,563
|
568,849
|
||||||||
Total
Stockholders’ Equity
|
47,294,410
|
6,127,003
|
||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
53,747,997
|
$
|
13,465,845
|
1
GENEREX
BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIES
|
||||||||||||||||
(A
DEVELOPMENT STAGE COMPANY)
|
||||||||||||||||
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
||||||||||||||||
Cumulative
From
|
||||||||||||||||
November
2, 1995
|
||||||||||||||||
For
the Three Months Ended
|
For
the Nine Months Ended
|
(Date
of Inception)
|
||||||||||||||
April
30,
|
April
30,
|
to
April 30,
|
||||||||||||||
2006
|
2005
|
2006
|
2005
|
2006
|
||||||||||||
Revenues
|
$
|
43,750
|
$
|
43,750
|
$
|
131,250
|
$
|
263,250
|
$
|
2,150,546
|
||||||
Operating
Expenses:
|
||||||||||||||||
Research
and development
|
1,635,238
|
1,009,799
|
3,628,732
|
6,586,764
|
58,547,177
|
|||||||||||
Research
and development -
|
||||||||||||||||
related
party
|
--
|
--
|
--
|
--
|
220,218
|
|||||||||||
General
and administrative
|
2,299,011
|
2,358,472
|
7,684,754
|
9,231,266
|
73,135,868
|
|||||||||||
General
and administrative -
|
||||||||||||||||
related
party
|
--
|
--
|
--
|
--
|
314,328
|
|||||||||||
Total
Operating Expenses
|
3,934,249
|
3,368,271
|
11,313,486
|
15,818,030
|
132,217,591
|
|||||||||||
Operating
Loss
|
(3,890,499
|
)
|
(3,324,521
|
)
|
(11,182,236
|
)
|
(15,554,780
|
)
|
(130,067,045
|
)
|
||||||
Other
Income (Expense):
|
||||||||||||||||
Miscellaneous
income (expense)
|
--
|
--
|
500
|
--
|
196,193
|
|||||||||||
Income
from Rental Operations, net
|
42,506
|
28,503
|
78,346
|
103,292
|
283,022
|
|||||||||||
Interest
income
|
241,053
|
3,015
|
257,149
|
21,791
|
3,651,629
|
|||||||||||
Interest
expense
|
(17,227,595
|
)
|
(1,403,667
|
)
|
(32,458,126
|
)
|
(2,223,183
|
)
|
(37,293,061
|
)
|
||||||
Loss
on extinguishment of debt
|
(10,938,959
|
)
|
--
|
(11,872,942
|
)
|
--
|
(13,219,283
|
)
|
||||||||
Net
Loss Before Undernoted
|
(31,773,494
|
)
|
(4,696,670
|
)
|
(55,177,309
|
)
|
(17,652,880
|
)
|
(176,448,545
|
)
|
||||||
Minority
Interest Share of Loss
|
--
|
--
|
--
|
--
|
3,038,185
|
|||||||||||
Net
Loss
|
(31,773,494
|
)
|
(4,696,670
|
)
|
(55,177,309
|
)
|
(17,652,880
|
)
|
(173,410,360
|
)
|
||||||
Preferred
Stock Dividend
|
--
|
--
|
--
|
--
|
2,295,057
|
|||||||||||
Net
Loss Available to Common
|
||||||||||||||||
Shareholders
|
$
|
(31,773,494
|
)
|
$
|
(4,696,670
|
)
|
$
|
(55,177,309
|
)
|
$
|
(17,652,880
|
)
|
$
|
(175,705,417
|
)
|
|
Basic
and Diluted Net Loss Per
|
||||||||||||||||
Common
Share
|
$
|
(.36
|
)
|
$
|
(.13
|
)
|
$
|
(.84
|
)
|
$
|
(.49
|
)
|
||||
Weighted
Average Number of Shares
|
||||||||||||||||
of
Common Stock Outstanding
|
88,683,352
|
36,099,735
|
65,719,702
|
35,743,730
|
2
GENEREX
BIOTECHNOLOGY CORPORATION AND
SUBSIDIARIES
|
||||||||||
(A
DEVELOPMENT STAGE COMPANY)
|
||||||||||
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
||||||||||
Cumulative
From
|
||||||||||
November
2, 1995
|
||||||||||
For
the Nine Months Ended
|
|
(Date
of Inception)
|
||||||||
April
30,
|
to
April 30,
|
|||||||||
2006
|
|
2005
|
2006
|
|||||||
Cash
Flows From Operating Activities:
|
||||||||||
Net
loss
|
$
|
(55,177,309
|
)
|
$
|
(17,652,880
|
)
|
$
|
(173,410,360
|
)
|
|
Adjustments
to reconcile net loss to net cash used
|
||||||||||
in
operating activities:
|
||||||||||
Depreciation
and amortization
|
846,239
|
827,459
|
4,427,419
|
|||||||
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
|
1,278
|
--
|
77,364
|
|||||||
Loss
on extinguishment of debt
|
11,872,942
|
--
|
13,219,283
|
|||||||
Common
stock issued as employee compensation
|
126,104
|
--
|
126,104
|
|||||||
Common
stock issued for services rendered
|
422,599
|
1,093,528
|
5,208,863
|
|||||||
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
|
137,200
|
530,600
|
6,971,073
|
|||||||
Issuance
of warrants as additional exercise right inducement
|
16,888,239
|
--
|
16,888,239
|
|||||||
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
|
1,195,315
|
155,988
|
1,443,422
|
|||||||
Amortization
of discount on convertible debentures
|
14,075,693
|
1,849,976
|
17,810,504
|
|||||||
Common
stock issued as interest payment on convertible debentures
|
168,365
|
--
|
245,361
|
|||||||
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
|
7,882
|
105,293
|
113,182
|
|||||||
Changes
in operating assets and liabilities (excluding the effects of
|
||||||||||
acquisition):
|
||||||||||
Miscellaneous
receivables
|
--
|
--
|
43,812
|
|||||||
Other
current assets
|
45,275
|
821,442
|
(66,966
|
)
|
||||||
Accounts
payable and accrued expenses
|
1,182,117
|
2,843,052
|
7,047,868
|
|||||||
Other,
net
|
--
|
--
|
110,317
|
|||||||
Net
Cash Used in Operating Activities
|
(8,056,162
|
)
|
(9,172,439
|
)
|
(98,139,958
|
)
|
||||
Cash
Flows From Investing Activities:
|
||||||||||
Purchase
of property and equipment
|
(85,168
|
)
|
(62,099
|
)
|
(4,377,884
|
)
|
||||
Costs
incurred for patents
|
(37,253
|
)
|
(169,573
|
)
|
(1,532,239
|
)
|
||||
Change
in restricted cash
|
214,364
|
(8,214
|
)
|
43,368
|
||||||
Proceeds
from maturity of short term investments
|
3,000,000
|
--
|
129,687,046
|
|||||||
Purchases
of short-term investments
|
(13,773,605
|
)
|
--
|
(140,460,651
|
)
|
|||||
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
|
--
|
395,889
|
(477,194
|
)
|
||||||
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
|
(10,681,662
|
)
|
149,703
|
(20,417,289
|
)
|
|||||
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
|
35,051
|
350,222
|
2,005,199
|
|||||||
Repayment
of long-term debt
|
(297,792
|
)
|
(60,068
|
)
|
(1,504,730
|
)
|
||||
Change
in due to related parties
|
--
|
--
|
154,541
|
|||||||
Proceeds
from exercise of warrants
|
32,819,119
|
--
|
37,372,103
|
|||||||
Proceeds
from exercise of stock options
|
3,174,555
|
--
|
4,184,995
|
|||||||
Proceeds
from minority interest investment
|
--
|
--
|
3,038,185
|
|||||||
Proceeds
from issuance of preferred stock
|
--
|
--
|
12,015,000
|
|||||||
Proceeds
from issuance of convertible debentures, net
|
13,955,000
|
4,299,930
|
20,254,930
|
|||||||
Repayments
of convertible debentures
|
--
|
(416,513
|
)
|
(461,358
|
)
|
|||||
Purchase
of treasury stock
|
--
|
--
|
(483,869
|
)
|
||||||
Proceeds
from issuance of common stock, net
|
--
|
--
|
73,283,715
|
|||||||
Purchase
and retirement of common stock
|
--
|
--
|
(119,066
|
)
|
||||||
Net
Cash Provided by (Used in) Financing Activities
|
49,338,564
|
4,498,750
|
149,717,455
|
|||||||
Effect
of Exchange Rates on Cash
|
(4,084
|
)
|
9,441
|
22,978
|
||||||
Net
Increase (Decrease) in Cash and Cash Equivalents
|
30,596,656
|
(4,514,545
|
)
|
31,183,186
|
||||||
Cash
and Cash Equivalents, Beginning of Period
|
586,530
|
4,950,419
|
--
|
|||||||
Cash
and Cash Equivalents, End of Period
|
$
|
31,183,186
|
$
|
435,874
|
$
|
31,183,186
|
3
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1.
Basis
of Presentation
The
accompanying unaudited interim consolidated financial statements have been
prepared pursuant to the rules and regulations for reporting on Form 10-Q.
Accordingly, certain information and disclosures required by generally accepted
accounting principles for complete financial statements are not included
herein.
The interim statements should be read in conjunction with the financial
statements and notes thereto included in the Company’s latest Annual Report on
Form 10-K. The results for the three and nine months may not be indicative
of
the results for the entire year.
Interim
statements are subject to possible adjustments in connection with the annual
audit of the Company’s accounts for the fiscal year 2006. In the Company’s
opinion all adjustments necessary for a fair presentation of these interim
statements have been included and are of a normal and recurring
nature.
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities
and commitments in the normal course of business. The Company has experienced
negative cash flows from operations since inception and had an accumulated
deficit at April 30, 2006 of approximately $176 million. The Company has
funded
its activities to date almost exclusively from debt and equity financings.
The
Company is in the development stage and has realized minimal revenues to
date.
The Company will continue to require substantial funds to continue research
and
development, including preclinical studies and clinical trials of its product
candidates, and to commence sales and marketing efforts if the FDA or other
regulatory approvals are obtained. Management’s plans in order to meet its
operating cash flow requirements include financing activities such as private
placement of its common stock, preferred stock offerings and offerings of
debt
and convertible debt instruments. Management is also actively pursuing industry
collaboration activities including product licensing and specific project
financing.
While
the
Company believes that it will be successful in obtaining the necessary financing
to fund its operations, there are no assurances that such additional funding
will be achieved and that it will succeed in its future operations. The
financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts or amounts of
liabilities that might be necessary should the Company be unable to continue
in
existence.
2.
Effects
of Recent Accounting Pronouncements
In
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
123(R), "Share-Based Payment" ("SFAS 123(R)"), which requires all companies
to
measure compensation cost for all share-based payments (including employee
stock
options) at fair value and to recognize cost over the vesting period. In
March
2005, the SEC released SEC Staff Accounting Bulletin No. 107, "Share-Based
Payment" ("SAB 107"). SAB 107 provides the SEC staff position regarding the
application of SFAS 123(R), including interpretive guidance related to the
interaction between SFAS 123(R) and certain SEC rules and regulations, and
provides the staff's views regarding the valuation of share-based payment
arrangements for public companies. SAB 107 highlights the importance of
disclosures made related to the accounting for share-based payment transactions.
In April 2005, the SEC announced that companies may implement SFAS 123(R)
at the
beginning of their next fiscal year beginning after June 15, 2005, or December
15, 2005 for small business issuers. The Company implemented the provisions
of
SFAS 123(R) and SAB 107 in the first quarter of fiscal 2006 using the
modified-prospective method, and it did not have a material impact on our
financial position or cash flows. See Note 3 - "Stock Based Compensation"
for
further information and the required disclosures under SFAS 123(R) and SAB
107,
including the impact of the implementation on our results of operations.
4
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
2.
|
Effects
of Recent Accounting Pronouncements
(Continued)
|
In
May
2005, the FASB issued SFAS No. 154, “Accounting Changes and Error Corrections.”
This statement replaces APB No. 20 and SFAS No. 3 and changes the requirements
for the accounting and reporting of a change in accounting principle. APB
No. 20
previously required that most voluntary changes in accounting principle be
recognized by including in net income of the period of the change the cumulative
effect of changing to the accounting principle. SFAS No. 154 requires
retrospective application to prior periods’ financial statements of voluntary
changes in accounting principle. SFAS No. 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December
15, 2005. The Company does not expect that the adoption of SFAS No. 154 will
have a significant impact on the consolidated results of operations or financial
position of the Company.
In
February 2006, the FASB issued SFAS No. 155,”Accounting for Certain Hybrid
Financial Instruments - an amendment of FASB Statements No. 133 and 140,” to
simplify and make more consistent the accounting for certain financial
instruments. Specifically, SFAS No. 155 amends SFAS No. 133, Accounting for
Derivative Instruments and Hedging Activities, to permit fair value
remeasurement for any hybrid financial instrument with an embedded derivative
that otherwise would require bifurcation, provided that the whole instrument
is
accounted for on a fair value basis. SFAS No. 155 amends SFAS No. 140,
Accounting for the Impairment or Disposal of Long-Lived Assets, to allow
a
qualifying special-purpose entity (SPE) to hold a derivative financial
instrument that pertains to a beneficial interest other than another derivative
financial instrument. SFAS No. 155 applies to all financial instruments acquired
or issued after the beginning of an entity’s first fiscal year that begins after
September 15, 2006, with earlier application allowed. The
Company does not expect that the adoption of SFAS No. 155 will have a
significant impact on the consolidated results of operations or financial
position of the Company.
In
March
2006, the FASB issued SFAS No. 156, “Accounting for Servicing of Financial
Assets”, to simplify accounting for separately recognized servicing assets and
servicing liabilities. SFAS No. 156 amends SFAS No. 140, “Accounting for
Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.
Additionally, SFAS No. 156 permits, but does not require, an entity to choose
either the amortization method or the fair value measurement method for
measuring each class of separately recognized servicing assets and servicing
liabilities. SFAS No. 156 applies to all separately recognized servicing
assets
and servicing liabilities acquired of issued after the beginning of an entity’s
fiscal year that begins after September 15, 2006, although early adoption
is
permitted. The Company believes that this SFAS will have no effect on the
Company’s financial condition or results of operations.
5
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
3.
|
Stock-Based
Compensation
|
As
of
April 30, 2006, the Company had two stockholder-approved stock incentive
plans
under which options exercisable for shares of common stock have been or may
be
granted to employees, directors, consultants and advisors. A total of 2,000,000
shares of common stock are reserved for issuance under the 2000 Stock Option
Plan (the 2000 Plan) and a total of 12,000,000 shares of common stock are
reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan). There
were 1,900,000 and 427,331 shares of common stock reserved for future awards
under the 2000 Plan and 2001 Plan, respectively, as of April 30,
2006.
The
2000
and 2001 Plans (the Plans) are administered by the Compensation Committee
(the
Committee). The Committee is authorized to select from among eligible employees,
directors, advisors and consultants those individuals to whom options are
to be
granted and to determine the number of shares to be subject to, and the terms
and conditions of the options. The Committee is also authorized to prescribe,
amend and rescind terms relating to options granted under the Plans. Generally,
the interpretation and construction of any provision of the Plans or any
options
granted hereunder is within the discretion of the Committee.
The
Plans
provide that options may or may not be Incentive Stock Options (ISOs) within
the
meaning of Section 422 of the Internal Revenue Code. Only employees of the
Company are eligible to receive ISOs, while employees and non-employee
directors, advisors and consultants are eligible to receive options which
are
not ISOs, i.e. “Non-Qualified Options.” The options granted by the Board in
connection with its adoption of the Plans are Non-Qualified
Options.
Prior
to
August 1, 2005, the Company accounted for the share-based compensation granted
under its stock incentive plans under the recognition and measurement provisions
of Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued
to
Employees," and related interpretations ("APB 25"). In accordance with APB
25,
the Company used the intrinsic-value method of accounting for stock option
awards to employees and accordingly did not recognize compensation expense
for
its stock option awards to employees in its Consolidated Statement of Operations
prior to August 1, 2005, as all option exercise prices were equal to the
fair
market value of the Company stock on the date the options were granted.
Effective August 1, 2005, the Company implemented the fair value recognition
provisions of Financial Accounting Standards Board (FASB) Statement No. 123
(revised 2004) ("SFAS 123 (R)"), "Share Based Payment," which is a revision
of
SFAS No. 123, "Accounting for Stock Based Compensation," and SAB 107 for
all
share-based compensation that was not vested as of July 31, 2005.
For
the
three and nine months ended April 30, 2006, no compensation expense was recorded
for options outstanding as of August 1, 2005. There were no options granted
during the three and nine months ended April 30, 2006.
The
following table illustrates the pro forma effect on net income and earnings
per
share for the three and nine months ended April 30, 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. The fair value of each option grant is
estimated at the grant date using the Black-Scholes option-pricing model
based
on the assumptions listed below. The estimated fair value of options granted
is
expensed at the date of grant. Share-based employee compensation for the
three
and nine months ended April 30, 2006 in the amount of $-0- (net of related
tax),
is included in the net loss of $31,773,494 and $55,177,309, respectively.
The
following table represents the impact had the treatment been adopted at August
1, 2004.
6
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
3.
|
Stock-Based
Compensation (Continued)
|
|
Nine
Months
|
Three
Months
|
|||||
|
Ended
|
Ended
|
|||||
|
April
30,
|
April
30,
|
|||||
|
2005
|
2005
|
|||||
Net
Loss Available to Common Stockholders,
|
|||||||
as
Reported
|
$
|
(17,652,880
|
)
|
$
|
(4,696,670
|
)
|
|
Add:
Total Stock-Based Employee Compensation
|
|||||||
Included
in Reported Net Loss
|
--
|
--
|
|||||
Deduct:
Total Stock-Based Employee Compensation
|
|||||||
Income
Determined Under Fair Value Based Method,
|
|||||||
Net
of Related Tax Effect
|
1,998,140
|
567,500
|
|||||
Pro
Forma Net Loss Available to Common Stockholders
|
$
|
(19,651,020
|
)
|
$
|
(5,264,170
|
)
|
|
Loss
Per Share:
|
|||||||
Basic
and diluted, as reported
|
$
|
(0.49
|
)
|
$
|
(0.13
|
)
|
|
Basic
and diluted, pro forma
|
$
|
(0.55
|
)
|
$
|
(0.15
|
)
|
The
implementation of the provisions of SFAS 123(R) and SAB 107 during the three
and
nine months ended April 30, 2006 did not have a material impact on the Company’s
cash flow from operations or cash flow from financing activities.
The
following information relates to stock options that have been granted under
the
Company’s stockholder-approved incentive plans. The stock option exercise price
is typically granted at 100 percent of the fair market value on the date
the
options are granted. Options may be exercised for a period of five years
commencing on the date of grant and typically vesting over two years from
the
date of grant.
The
fair
value of each option award is estimated on the date of grant using the
Black-Scholes option pricing model. No options were granted to employees
during
the three and nine months ended April 30, 2006.
The
summary of the stock option activity for the nine months ended April 30,
2006 is
as follows:
Weighted
|
Weighted
|
|||||||||
Average
|
Average
|
|||||||||
Exercise
|
Remaining
|
|||||||||
Price
|
Contractual
|
|||||||||
Shares
|
Share
|
Term
(Years)
|
||||||||
Outstanding,
August 1, 2005
|
11,607,269
|
$
|
1.51
|
3.65
|
||||||
Granted
|
--
|
$
|
--
|
--
|
||||||
Cancelled
|
(140,000
|
)
|
$
|
9.41
|
--
|
|||||
Exercised
|
(2,317,672
|
)
|
$
|
1.19
|
--
|
|||||
Outstanding,
April 30, 2006
|
9,149,597
|
$
|
1.42
|
3.04
|
7
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
3.
|
Stock-Based
Compensation (Continued)
|
The
summary of the status of the Company’s non-vested as of April 30, 2006, as
changed during the nine months then ended is as follows:
Weighted
|
|||||||
Average
|
|||||||
Grant
Date
|
|||||||
Shares
|
Fair
Value
|
||||||
Non-vested
Stock Options, August 1, 2005
|
628,000
|
$
|
0.72
|
||||
Granted
|
--
|
$
|
--
|
||||
Cancelled
|
--
|
$
|
--
|
||||
Vested
|
(628,000
|
)
|
$
|
0.72
|
|||
Non-vested
Stock Options, April 30, 2006
|
--
|
$
|
--
|
As
of
April 30, 2006, there was no unrecognized compensation related to non-vested
stock options granted under the Company’s stock option plans.
4.
|
Comprehensive
Income/(Loss)
|
Comprehensive
loss, which includes net loss and the change in the foreign currency translation
account during the period, for the three months ended April 30, 2006 and
2005,
was $31,708,769 and $4,740,742, respectively and for the nine months ended
April
30, 2006 and 2005 was $54,964,595 and $17,443,659, respectively.
5.
|
Accounts
Payable and Accrued
Expenses
|
Accounts
payable and accrued expenses consist of the following:
April
30,
|
July
31,
|
||||||
2006
|
2005
|
||||||
Accounts
Payable
|
$
|
786,024
|
$
|
999,726
|
|||
Accounting
and Auditing
|
122,430
|
274,627
|
|||||
Accrued
Legal Fees and Settlement
|
134,665
|
599,461
|
|||||
Termination
Agreements and Severance Pay
|
179,120
|
265,720
|
|||||
Executive
Compensation and Directors Fees
|
1,624,172
|
271,312
|
|||||
Total
|
$
|
2,846,411
|
$
|
2,410,846
|
6.
|
Convertible
Debentures
|
$4
Million Convertible Debenture
On
November 8, 2004, the Company entered into four definitive agreements with
four
accredited investors, pursuant to which the Company would issue four $1,000,000
convertible promissory notes (“convertible debentures”) for aggregate gross
proceeds of $4,000,000. The notes carry a 6% coupon and a 15-month term and
amortize in 13 equal monthly installments commencing in the third month of
the
term. The convertible debentures are convertible into registered common stock
of
the Company at $0.82 per share. 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
$0.82,
subject to certain restrictions. The transaction terms include 100% five-year
warrant coverage at a per share exercise price equal to a 10% premium to
the
10-day VWAP on the closing date and a 100% additional investment right
exercisable for up to twelve months following the effective date of the
registration statement in respect of the transaction.
8
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
$4
Million Convertible Debenture (Continued)
During
December 2004, the Company issued the aforementioned convertible debentures.
Proceeds related to the issuance, net of issuance costs of $389,970, amounted
to
$3,699,930. Included in the issuance costs were warrants issued to a third
party
to purchase 145,000 shares of common stock at $0.91 per share. The fair value
of
the warrant was determined to be $89,900 using the Black Scholes pricing
model
assuming a risk-free rate of 1.79 percent, an expected volatility of 1.0463
and
a five year life. The fair value of the warrant, which has been allocated
to
additional paid in capital, and together with the $300,070 of issuance costs
is
being amortized over the life of the debt as a deferred debt issuance cost.
During the nine months ended April 30, 2006, $155,988 has been amortized
as
interest expense and the remaining unamortized balance of $-0- is included
in
deferred debt issuance costs.
The
holders of the convertible debentures also received warrants to purchase
4,878,048 of common stock at $0.91 per share. 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 in the amount of $1,722,222 to additional paid-in capital and a
discount against the convertible debenture. The Company valued the warrants
in
accordance with EITF 00-27 using the Black-Scholes pricing model assuming
a
risk-free rate of 1.79 percent, an expected volatility of 1.0463 and a five
year
life. 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.
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 the value
attributable to the beneficial conversion feature, valued at $1,722,222,
to
additional paid-in capital and a discount against the convertible debenture.
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.
The
Company amortized the convertible debenture debt discount attributed to the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $630,452 during the nine months ended April
30,
2006. During the nine months ended April 30, 2006, the Company has issued
646,834 shares of common stock to the holders of the convertible debentures
upon
receipt of the holders’ notice of conversion of principal and interest totaling
$530,403. This conversion resulted in a charge of $42,409 to loss on
extinguishment of debt that represents the difference between quoted market
price of the Company’s common stock and 10 percent discount to the average of
the 20-day VWAP.
The
Company has repaid the note holders $693,671 of the principal and interest
in
1,169,613 shares of common stock during the nine months ended April 30, 2006.
This repayment resulted in a charge of $147,457 to loss on extinguishment
of
debt that represents the difference between quoted market price of the Company’s
common stock and 10 percent discount to the average of the 20-day VWAP. The
note
holders have converted the balance of the debenture prior to the period
end.
$500,000
Convertible Debenture
On
March
28, 2005, the Company entered into a definitive agreement pursuant to which
the
Company would issue a convertible promissory note for aggregate gross proceeds
of $500,000. The note bore interest at 10 percent per annum payable in common
stock at the holders option and was due on May 15, 2005. The note was
convertible into registered common stock of the Company at a per share price
equal $0.82.
9
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
$500,000
Convertible Debenture (Continued)
The
holder of the convertible debenture also received warrants to purchase 1,219,512
of common stock at $0.82 per share. In accordance with EITF 00-27 the Company
recognized the value attributable to the warrants, in the amount of $245,521,
to
additional paid-in capital and a discount against the convertible debenture.
The
Company valued the warrants in accordance with EITF 00-27 using the
Black-Scholes pricing model assuming a risk-free rate of 2.78 percent, an
expected volatility of 1.0054 and a five year life. The debt discount attributed
to the value of the warrants issued is amortized over the convertible note’s
maturity period as interest expense using the effective yield
method.
In
accordance with EITF 98-5, the Company recognized the value attributable
to the
beneficial conversion feature valued at $86,984, to additional paid-in capital
and a discount against the convertible note. The debt discount attributed
to the
beneficial conversion feature is amortized over the convertible note's maturity
period as interest expense using the effective yield method.
The
Company fully amortized the convertible note debt discount attributed to
the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $332,505 during the year ended July 31, 2005.
On
June
7, 2005 the Company entered into an agreement with the note holder to extend
the
maturity date of the convertible note to July 22, 2005. In consideration
for the
holder’s agreement to amend the original convertible note the Company granted a
warrant to purchase 1,219,512 shares of common stock at $0.82 per share with
an
expiration of June 10, 2010. In accordance with EITF 98-5 the fair value
of the
warrants, $597,561, was determined to be the reacquisition price on the debt
on
the extinguishment date and was recorded as a loss on extinguishment of the
debt. It was then determined that the new debt did not have a beneficial
conversion feature.
On
July
22, 2005 the Company entered into an agreement with the note holder to extend
the maturity date of the convertible note to September 20, 2005. In
consideration for the holder’s agreement to amend the original convertible note
the Company granted a warrant to purchase 1,219,512 shares of common stock
at
$0.82 per share with an expiration of July 22, 2010. In accordance with EITF
98-5 the fair value of the warrants, $524,390, was determined to be the
reacquisition price on the debt on the extinguishment date and was recorded
as a
loss on extinguishment of the debt. It was then determined that the new debt
did
not have a beneficial conversion feature.
During
the nine months ended April 30, 2006, the Company issued 644,003 shares of
common stock to the holder of the convertible note upon receipt of the holder’s
notice of conversion of principal and interest totaling $528,082. The note
holders have converted the balance of the debenture prior to the period
end.
$100,000
Convertible Debenture
On
April
4, 2005, the Company entered into a definitive agreement pursuant to which
the
Company would issue a convertible promissory note for aggregate gross proceeds
of $100,000. The note bore interest at 10 percent per annum payable in common
stock at the holders option and was due on May 15, 2005. The note was
convertible into registered common stock of the Company at a per share price
equal $0.82.
10
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
$100,000
Convertible Debenture (Continued)
The
holder of the convertible note also received warrants to purchase 243,902
of
common stock at $0.82 per share. In accordance with EITF 00-27, the Company
recognized the value attributable to the warrants in the amount of $49,104
to
additional paid-in capital and a discount against the convertible note. The
Company valued the warrants in accordance with EITF 00-27 using the
Black-Scholes pricing model assuming a risk-free rate of 2.78 percent, an
expected volatility of 1.0054 and a five year life. The debt discount attributed
to the value of the warrants issued is amortized over the convertible note’s
maturity period as interest expense using the effective yield
method.
In
accordance with EITF 98-5, the Company recognized the value attributable
to the
beneficial conversion feature valued at $17,397, to additional paid-in capital
and a discount against the convertible note. The debt discount attributed
to the
beneficial conversion feature is amortized over the convertible note's maturity
period as interest expense using the effective yield method.
The
Company fully amortized the convertible note debt discount attributed to
the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $66,501 during the year ended July 31, 2005.
On
June
7, 2005 the Company entered into an agreement with the note holder to extend
the
maturity date of the convertible note to July 22, 2005. In consideration
for the
holder’s agreement to amend the original convertible note the Company granted a
warrant to purchase 243,902 shares of common stock at $0.82 per share with
an
expiration of June 10, 2010. In accordance with EITF 98-5 the fair value
of the
warrants, $119,512 was determined to be the reacquisition price on the debt
on
the extinguishment date and was recorded as a loss on extinguishment of the
debt. It was then determined that the new debt did not have a beneficial
conversion feature.
On
July
22, 2005 the Company entered into an agreement with the note holder to extend
the maturity date of the convertible note to September 20, 2005. In
consideration for the holder’s agreement to amend the original convertible note
the Company granted a warrant to purchase 243,902 shares of common stock
at
$0.82 per share with an expiration of July 22, 2010. In accordance with EITF
98-5 the fair value of the warrants, $104,878 was determined to be the
reacquisition price on the debt on the extinguishment date and was recorded
as a
loss on extinguishment of the debt. It was then determined that the new debt
did
not have a beneficial conversion feature.
During
the nine months ended April 30, 2006, the Company issued 128,834 shares of
common stock to the holders of the convertible note upon receipt of the holder’s
notice of conversion of principal and interest totaling $105,644. The note
holders have converted the balance of the debenture prior to the period
end.
11
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
$2
Million Convertible Debenture
On
June
17, 2005, the holders of the $4 million convertible debenture exercised 50
percent of their additional investment right “AIR Exercise” resulting in four
$500,000 convertible promissory notes (“convertible debentures’) for an
aggregate proceeds of $2,000,000. The notes carry a 6% coupon and a 15-month
term and amortize in 13 equal monthly installments commencing in the third
month
of the term. The convertible debentures are convertible into registered common
stock of the Company at $0.82 per share. 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 $0.82, subject to certain restrictions. The transaction terms include
100% five-year warrant coverage at a per share exercise price equal to a
10%
premium to the 10-day VWAP on the closing date and a 100% additional investment
right exercisable for up to twelve months following the effective date of
the
registration statement in respect of the transaction. In consideration of
the
AIR Exercise the Company reduced the conversion price of the convertible
debentures issuable upon the AIR Exercise from $0.82 to $0.60 per share.
Proceeds
related to the AIR Exercise, net of issuance costs of $160,300, amounted
to
$1,839,700. Included in the issuance costs were warrants to purchase 35,000
shares of common stock at $0.82 per share and 170,732 shares of common stock
valued at $0.82 per share issued to a third party. The fair value of the
warrant
was determined to be $20,300 using the Black Scholes pricing model assuming
a
risk-free rate of 3.02 percent, an expected volatility of 0.9775 and a five
year
life. The fair value of the warrant, which has been allocated to additional
paid
in capital, together with the $140,000 of issuance costs is being amortized
over
the life of the debt as a deferred debt issuance cost. During the nine months
ended April 30, 2006, the Company has amortized the remaining balance of
deferred debt issuance costs in the amount of $155,129 as non-cash interest
expense resulting from the convertible debenture being fully repaid and the
remaining unamortized balance of $-0- is included in deferred debt issuance
costs.
The
holders of the convertible debentures also received warrants to purchase
2,439,024 shares of common stock at $0.82 per share. In accordance with EITF
00-27, the Company recognized the value attributable to the warrants in the
amount of $828,571 to additional paid-in capital and a discount against the
convertible debenture. The Company valued the warrants in accordance with
EITF
00-27 using the Black-Scholes pricing model assuming a risk-free rate of
3.02
percent, an expected volatility of 0.9775 and a five year life. 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.
In
accordance with EITF 98-5 the Company recognized the value attributable to
the
beneficial conversion feature valued at $1,171,429, to additional paid-in
capital and a discount against the convertible debenture. 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.
The
Company amortized the convertible debenture debt discount attributed to the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $62,316 for the nine months ended April 30,
2006.
During the nine months ended April 30, 2006, the Company has issued 2,363,352
shares of common stock to the holders of the convertible debentures upon
receipt
of the holders’ notice of conversions of principal and interest totaling
$1,418,011.
12
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
$2
Million Convertible Debenture (Continued)
The
Company has repaid the note holders $225,322 of the principal and interest
in
407,075 shares of common stock during the nine months ended April 30, 2006.
This
repayment resulted in a charge of $62,242 to loss on extinguishment of debt
that
represents the difference between quoted market price of the Company’s common
stock and 10 percent discount to the average of the 20-day VWAP. The note
holders have converted the balance of the debenture prior to the period
end.
Second
$2 Million Convertible Debenture
On
September 8, 2005, the holders of the $2 million convertible debenture exercised
their additional investment right “AIR Exercise” resulting in four $500,000
convertible promissory notes (“convertible debentures’) for an aggregate
proceeds of $2,000,000. The notes carry a 6% coupon and a 15-month term and
amortize in 13 equal monthly installments commencing in the third month of
the
term. The convertible debentures are convertible into registered common stock
of
the Company at $0.82 per share. 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
$0.82,
subject to certain restrictions. The transaction terms include 100% five-year
warrant coverage at a per share exercise price equal to a 10% premium to
the
10-day VWAP on the closing date and a 100% additional investment right
exercisable for up to twelve months following the effective date of the
registration statement in respect of the transaction. In consideration of
the
AIR Exercise the Company reduced the conversion price of the convertible
debentures issuable upon the AIR Exercise from $0.82 to $0.60 per share.
Proceeds
related to the AIR Exercise, net of issuance costs of $185,600, amounted
to
$1,814,400. Included in the issuance costs were warrants to purchase 60,000
shares of common stock at $0.82 per share and 170,732 shares of common stock
valued at $0.82 per share issued to a third party. The fair value of the
warrant
was determined to be $30,600 using the Black Scholes pricing model assuming
a
risk-free rate of 3.76 percent, an expected volatility of 0.9232 and a five
year
life. The fair value of the warrant, which has been allocated to additional
paid
in capital, together with the $140,000 of issuance costs associated with
the
shares of common stock issued and $15,000 of legal costs are being amortized
over the life of the debt as a deferred debt issuance cost. During the nine
months ended April 30, 2006, $185,600 has been amortized as interest expense
and
the remaining unamortized balance of $-0- is included in deferred debt issuance
costs.
The
holders of the convertible debentures also received warrants to purchase
2,439,024 shares of common stock at $0.82 per share. In accordance with EITF
00-27, the Company recognized the value attributable to the warrants in the
amount of $785,185 to additional paid-in capital and a discount against the
convertible debenture. The Company valued the warrants in accordance with
EITF
00-27 using the Black-Scholes pricing model assuming a risk-free rate of
3.76
percent, an expected volatility of 0.9232 and a five year life. 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.
In
accordance with EITF 98-5 the Company recognized the value attributable to
the
beneficial conversion feature valued at $1,185,185, to additional paid-in
capital and a discount against the convertible debenture. 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.
13
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
Second
$2 Million Convertible Debenture (Continued)
The
Company amortized the convertible debenture debt discount attributed to the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $1,970,370 for the nine months ended April 30,
2006. During the nine months ended April 30, 2006, the Company has issued
2,878,648 shares of common stock to the holders of the convertible debentures
upon receipt of the holders’ notice of conversions of principal and interest
totaling $1,729,144. This conversion resulted in a charge of $1,088,868 to
loss
on extinguishment of debt that represents the difference between quoted market
price of the Company’s common stock and 10 percent discount to the average of
the 20-day VWAP.
The
Company has repaid the note holders $293,893 of the principal and interest
in
489,824 shares of common stock during the nine months ended April 30, 2006.
This
repayment resulted in a charge of $394,913 to loss on extinguishment of debt
that represents the difference between quoted market price of the Company’s
common stock and 10 percent discount to the average of the 20-day VWAP. The
note
holders have converted the balance of the debenture prior to the period
end.
Second
$500,000 Convertible Debenture
On
October 27, 2005, one of the debenture holders exercised its additional
investment right “AIR Exercise” resulting in a $500,000 convertible promissory
note (“convertible debenture’) for an aggregate proceeds of $500,000. The
convertible debenture carries a 6% coupon and a 15-month term and amortize
in 13
equal monthly installments commencing in the third month of the term. The
convertible debenture is convertible into registered common stock of the
Company
at $0.82 per share. 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 $0.82, subject
to
certain restrictions. The transaction terms include 100% five-year warrant
coverage at a per share exercise price equal to a 10% premium to the 10-day
VWAP
on the closing date and a 100% additional investment right exercisable for
up to
twelve months following the effective date of the registration statement
in
respect of the transaction.
Proceeds
related to the AIR Exercise, net of issuance costs of $49,250, amounted to
$500,000. Included in the issuance costs were warrants to purchase 15,000
shares
of common stock at $0.95 per share and commissions of $35,000 issued to a
third
party. The fair value of the warrant was determined to be $14,250 using the
Black Scholes pricing model assuming a risk-free rate of 3.76 percent, an
expected volatility of 0.9322 and a five year life. The fair value of the
warrant, which has been allocated to additional paid in capital, together
with
the $35,000 of issuance costs associated with the shares of common stock
issued
are being amortized over the life of the debt as a deferred debt issuance
cost.
During the nine months ended April 30, 2006, $49,250 has been amortized as
interest expense and the remaining unamortized balance of $-0- is included
in
deferred debt issuance costs.
The
holder of the convertible debenture also received warrants to purchase 609,756
shares of common stock at $0.82 per share. In accordance with EITF 00-27,
the
Company recognized the value attributable to the warrants in the amount of
$270,950 to additional paid-in capital and a discount against the convertible
debenture. The Company valued the warrants in accordance with EITF 00-27
using
the Black-Scholes pricing model assuming a risk-free rate of 3.76 percent,
an
expected volatility of 0.9232 and a five year life. 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.
14
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
Second
$500,000 Convertible Debenture (Continued)
In
accordance with EITF 98-5 the Company recognized the value attributable to
the
beneficial conversion feature valued at $229,050, to additional paid-in capital
and a discount against the convertible debenture. 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.
The
Company amortized the convertible debenture debt discount attributed to the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $500,000 for the nine months ended April 30,
2006.
During the nine months ended April 30, 2006, the Company has issued 470,450
shares of common stock to the holders of the convertible debentures upon
receipt
of the holders’ notice of conversions of principal and interest totaling
$385,769. This conversion resulted in a charge of $1,180,830 to loss on
extinguishment of debt that represents the difference between quoted market
price of the Company’s common stock and 10 percent discount to the average of
the 20-day VWAP.
The
Company has repaid the note holders $125,244 of the principal and interest
in
152,736 shares of common stock during the nine months ended April 30, 2006.
This
repayment resulted in a charge of $93,362 to loss on extinguishment of debt
that
represents the difference between quoted market price of the Company’s common
stock and 10 percent discount to the average of the 20-day VWAP. The note
holders have converted the balance of the debenture prior to the period
end.
$3,500,000
Convertible Debenture
On
December 4, 2005, the Company and each of the holders of the $4 million
convertible debenture entered into an Amendment No. 3 to Securities Purchase
Agreement and Registration Rights Agreement pursuant to which (i) all but
one of
the Investors agreed to exercise an aggregate of $1,500,000 in principal
amount
(“$3.5 Million Convertible Debenture”) of the Additional AIRs granted to such
Investors in connection with the Second AIR Exercise resulting in a $3,500,000
convertible promissory note (“convertible debenture’) for an aggregate proceeds
of $3,500,000. The convertible debenture carries a 6% coupon and a 15-month
term
and amortize in 13 equal monthly installments commencing in the third month
of
the term. The convertible debenture is convertible into registered common
stock
of the Company at $0.82 per share. 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 $0.82, subject to certain restrictions. The transaction terms include
100% five-year warrant coverage at a per share exercise price equal to a
10%
premium to the 10-day VWAP on the closing date and a 100% additional investment
right exercisable for up to twelve months following the effective date of
the
registration statement in respect of the transaction.
Proceeds
related to the AIR Exercise, net of issuance costs of $15,000, amounted to
$3,485,000. Included in the issuance costs were warrants to purchase 105,000
shares of common stock at $0.82 per share and 224,000 shares of common stock
valued at $0.95 per share issued to a third party. The fair value of the
warrant
was determined to be $76,650 using the Black Scholes pricing model assuming
a
risk-free rate of 4.02 percent, an expected volatility of 0.9288 and a five
year
life. The fair value of the warrant, which has been allocated to additional
paid
in capital, together with the $212,800 of issuance costs associated with
the
shares of common stock issued and $15,000 of legal costs are being amortized
over the life of the debt as a deferred debt issuance cost. During the nine
months ended April 30, 2006, $304,450 has been amortized as interest expense
and
the remaining unamortized balance of $-0- is included in deferred debt issuance
costs.
15
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
$3,500,000
Convertible Debenture (Continued)
The
holder of the convertible debenture also received warrants to purchase 4,268,292
shares of common stock at $0.82 per share. In accordance with EITF 00-27,
the
Company recognized the value attributable to the warrants in the amount of
$1,648,387 to additional paid-in capital and a discount against the convertible
debenture. The Company valued the warrants in accordance with EITF 00-27
using
the Black-Scholes pricing model assuming a risk-free rate of 4.02 percent,
an
expected volatility of 0.9288 and a five year life. 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.
In
accordance with EITF 98-5 the Company recognized the value attributable to
the
beneficial conversion feature valued at $1,851,613, to additional paid-in
capital and a discount against the convertible debenture. 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.
The
Company amortized the convertible debenture debt discount attributed to the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $3,500,000 for the nine months ended April 30,
2006. During the nine months ended April 30, 2006, the Company has issued
4,189,923 shares of common stock to the holders of the convertible debentures
upon receipt of the holders’ notice of conversions of principal and interest
totaling $3,435,735. This conversion resulted in a charge of $1,473,115 to
loss
on extinguishment of debt that represents the difference between quoted market
price of the Company’s common stock and 10 percent discount to the average of
the 20-day VWAP.
The
Company has repaid the note holders $86,475 of the principal and interest
in
105,456 shares of common stock during the nine months ended April 30, 2006.
This
repayment resulted in a charge of $176,556 to loss on extinguishment of debt
that represents the difference between quoted market price of the Company’s
common stock and 10 percent discount to the average of the 20-day VWAP. The
note
holders have converted the balance of the debenture prior to the period
end.
Second
$4,000,000 Convertible Debenture
On
January 20, 2006, the Company and each of the holders of the $4 million
convertible debenture entered into an Amendment No. 4 to Securities Purchase
Agreement and Registration Rights Agreement pursuant to which the investors
agreed to exercise an additional $4,000,000 in principal amount of Additional
Investment Rights (AIR) (“Second $4 Million Convertible Debenture”) of the
Additional AIRs granted to such Investors in connection with the Third AIR
Exercise resulting in a $4,000,000 convertible promissory note (“convertible
debenture’) for an aggregate proceeds of $4,000,000. The convertible debenture
carries a 6% coupon and a 15-month term and amortize in 13 equal monthly
installments commencing in the third month of the term. The convertible
debenture is convertible into registered common stock of the Company at $1.05
per share. 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 $0.82, subject to certain
restrictions. The transaction terms include 100% five-year warrant coverage
at a
per share exercise price equal to a 10% premium to the 10-day VWAP on the
closing date and a 100% additional investment right exercisable for up to
twelve
months following the effective date of the registration statement in respect
of
the transaction.
16
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
Second
$4,000,000 Convertible Debenture (Continued)
Proceeds
related to the AIR Exercise, net of issuance costs of $15,000, amounted to
$3,985,000. Included in the issuance costs were warrants to purchase 120,000
shares of common stock at $1.05 per share and 266,667 shares of common stock
valued at $1.00 per share issued to a third party. The fair value of the
warrant
was determined to be $88,800 using the Black Scholes pricing model assuming
a
risk-free rate of 4.23 percent, an expected volatility of 0.9210 and a five
year
life. The fair value of the warrant, which has been allocated to additional
paid
in capital, together with the $266,667 of issuance costs associated with
the
shares of common stock issued and $15,000 of legal costs are being amortized
over the life of the debt as a deferred debt issuance cost. During the nine
months ended April 30, 2006, $338,396 has been amortized as interest expense
and
the remaining unamortized balance of $32,071 is included in deferred debt
issuance costs.
The
holder of the convertible debenture also received warrants to purchase 3,809,524
shares of common stock at $1.05 per share. In accordance with EITF 00-27,
the
Company recognized the value attributable to the warrants in the amount of
$1,653,631 to additional paid-in capital and a discount against the convertible
debenture. The Company valued the warrants in accordance with EITF 00-27
using
the Black-Scholes pricing model assuming a risk-free rate of 4.23 percent,
an
expected volatility of 0.9210 and a five year life. 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.
In
accordance with EITF 98-5 the Company recognized the value attributable to
the
beneficial conversion feature valued at $1,463,155, to additional paid-in
capital and a discount against the convertible debenture. 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.
The
Company amortized the convertible debenture debt discount attributed to the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $2,957,773 for the nine months ended April 30,
2006. During the nine months ended April 30, 2006, the Company has issued
3,461,946 shares of common stock to the holders of the convertible debentures
upon receipt of the holders’ notice of conversions of principal and interest
totaling $3,635,041. This conversion resulted in a charge of $4,558,356 to
loss
on extinguishment of debt that represents the difference between quoted market
price of the Company’s common stock and 10 percent discount to the average of
the 20-day VWAP.
The
Company has repaid the note holders $175,501 of the principal and interest
in
167,144 shares of common stock during the nine months ended April 30, 2006.
This
repayment resulted in a charge of $275,788 to loss on extinguishment of debt
that represents the difference between quoted market price of the Company’s
common stock and 10 percent discount to the average of the 20-day
VWAP.
17
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
6.
|
Convertible
Debentures (Continued)
|
Third
$4,000,000 Convertible Debenture
On
February 28, 2006, the holders of the Second $4 million convertible debenture
exercised their additional investment right “AIR Exercise” resulting in four
$1,000,000 convertible promissory notes (“convertible debentures’) for an
aggregate proceeds of $4,000,000. The convertible debentures carry a 6% coupon
and a 15-month term and amortize in 13 equal monthly installments commencing
in
the third month of the term. The convertible debentures are convertible into
registered common stock of the Company at $1.25 per share. 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 $1.25, subject to certain restrictions. The Company
did
not incur issuance costs associated with the proceeds.
The
holder of the convertible debenture also received warrants to purchase 3,200,000
shares of common stock at $1.25 per share. In accordance with EITF 00-27,
the
Company recognized the value attributable to the warrants in the amount of
$2,374,507 to additional paid-in capital and a discount against the convertible
debenture. The Company valued the warrants in accordance with EITF 00-27
using
the Black-Scholes pricing model assuming a risk-free rate of 4.49 percent,
an
expected volatility of 0.9380 and a 5.5 year life. 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.
In
accordance with EITF 98-5 the Company recognized the value attributable to
the
beneficial conversion feature valued at $1,625,493, to additional paid-in
capital and a discount against the convertible debenture. 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.
The
Company amortized the convertible debenture debt discount attributed to the
beneficial conversion feature and the value of the warrants and recorded
non-cash interest expense of $3,039,090 for the nine months ended April 30,
2006. During the nine months ended April 30, 2006, the Company has issued
2,280,592 shares of common stock to the holders of the convertible debentures
upon receipt of the holders’ notice of conversions of principal and interest
totaling $2,850,739. This conversion resulted in a charge of $2,373,363 to
loss
on extinguishment of debt that represents the difference between quoted market
price of the Company’s common stock and 10 percent discount to the average of
the 20-day VWAP.
During
the nine months ended April 30, 2006, the Company has not repaid monthly
principal and interest through the issuance of shares of common
stock.
18
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
7.
|
Short-term
Advance
|
On
March
30, 2005, the Company entered into an agreement with an affiliated party
to
provide the Company with approximately $325,200 in funding. The funds were
designated to assist the Company in satisfying its obligations under the
terms
of the first $4,000,000 convertible debenture agreements. The Company is
obligated to repay the advance, without interest, in three equal installments
on
October 1, 2005, November 1, 2005 and December 1, 2005. Upon failure to repay
any installment when due, all amounts become payable on demand and interest
on
such unpaid amounts will accrue interest at the rate of 8 percent per annum.
The
Company did not make the required installments, therefore, has accrued interest
in the amount of $22,190. During the three months ended April 30, 2006, the
Company has repaid the short-term advance together with accrued interest
in the
amount of $347,369.
8. Pending
Litigation
On
October 2, 1998, Sands Brothers & Co. Ltd. (“Sands”), a New York City-based
investment banking and brokerage firm, initiated an arbitration proceeding
against the Company under the rules of the New York Stock Exchange in respect
of
an alleged contractual relationship between Sands and the Company.
On
August
17, 2004, following various arbitration and court proceedings in the case,
the
Arbitration Panel of the New York Stock Exchange issued a final award in
the
case, awarding Sands $150,000 in damages. A motion to confirm this award
was granted on February 1, 2005. In September 2005 Sands filed a motion
seeking leave from the New York Court of Appeals to appeal certain prior
orders
of the Appellate Division in the case. On January 10, 2006 the New York Court
of
Appeals denied the motion. In March, 2006 the Company paid $150,000 plus
$10,541
in interest to Sands in satisfaction of the judgment.
In
February 2001, a former business associate of the former Vice President of
Research and Development (VP), and an entity called Centrum Technologies
Inc.
(“CTI”) commenced an action in the Ontario Superior Court of Justice against the
Company and the VP seeking, among other things, damages for alleged breaches
of
contract and tortious acts related to a business relationship between this
former associate and the VP that ceased in July 1996. The plaintiffs’ statement
of claim also seeks to enjoin the use, if any, by the Company of three patents
allegedly owned by the company called CTI. On July 20, 2001, the Company
filed a
preliminary motion to dismiss the action of CTI as a nonexistent entity or,
alternatively, to stay such action on the grounds of want of authority of
such
entity to commence the action. The plaintiffs brought a cross motion to amend
the statement of claim to substitute Centrum Biotechnologies, Inc. (“CBI”) for
CTI. CBI is a corporation of which 50 percent of the shares are owned by
the
former business associate and the remaining 50 percent are owned by the Company.
Consequently, the shareholders of CBI are in a deadlock. The court granted
the
Company’s motion to dismiss the action of CTI and denied the plaintiffs’ cross
motion without prejudice to the former business associate to seek leave to
bring
a derivative action in the name of or on behalf of CBI. The former business
associate subsequently filed an application with the Ontario Superior Court
of
Justice for an order granting him leave to file an action in the name of
and on
behalf of CBI against the VP and the Company. The Company opposed the
application. In September 2003, the Ontario Superior Court of Justice granted
the request and issued an order giving the former business associate leave
to
file an action in the name of and on behalf of CBI against the VP and the
Company. A statement of claim was served in July 2004. The Company is not
able
to predict the ultimate outcome of this legal proceeding at the present time
or
to estimate an amount or range of potential loss, if any, from this legal
proceeding.
19
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
8.
|
Pending
Litigation (Continued)
|
In
February 2005, a consultant commenced an action in the Ontario Superior Court
of
Justice against the Company seeking approximately $600,000 in damages for
alleged contract breaches in respect of unpaid remuneration and other
compensation allegedly owed to him. In March 2006 the litigation was settled,
without any economic payment by the Company, and the action was dismissed,
on
consent, without costs.
The
Company is involved in certain other legal proceedings in addition to those
specifically described herein. Subject to the uncertainty inherent in all
litigation, the Company does not believe at the present time that the resolution
of any of these legal proceedings is likely to have a material adverse effect
on
the Company’s financial position, operations or cash flows.
With
respect to all litigation, as additional information concerning the estimates
used by the Company becomes known, the Company reassesses its position both
with
respect to accrued liabilities and other potential exposures.
9.
|
Net
Loss Per Share
|
Basic
EPS
and Diluted EPS for the three months and nine months ended April 30, 2006
and
2005 have been computed by dividing the net loss for each respective period
by
the weighted average number of shares outstanding during that period. All
outstanding warrants and options, approximately 25,246,229 and 26,485,026
incremental shares at April 30, 2006 and 2005, respectively, have been excluded
from the computation of Diluted EPS as they are anti-dilutive.
20
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
10.
|
Supplemental
Disclosure of Cash Flow
Information
|
For
the Nine Months Ended
|
|||||||
|
April
30,
|
||||||
Cash
paid during the period for:
|
2006
|
2005
|
|||||
Interest
|
$
|
49,864
|
$
|
260,973
|
|||
Income
taxes
|
$
|
--
|
$
|
--
|
|||
Disclosure
of non-cash investing and financing activities:
|
|||||||
Value
of common stock issued in conjunction with capitalized
|
|||||||
services
upon issuance of convertible debentures
|
$
|
619,467
|
$
|
--
|
|||
Value
of warrants issued in conjunction with capitalized
|
|||||||
services
upon issuance of convertible debentures
|
$
|
210,300
|
$
|
89,900
|
|||
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
|
$
|
3,843,450
|
|||
Satisfaction
of accounts payable through the issuance of
|
|||||||
common
stock
|
$
|
391,147
|
$
|
779,760
|
|||
Principal
repayment of convertible debentures through the
|
|||||||
issuance
of common stock
|
$
|
1,498,843
|
$
|
506,824
|
|||
Issuance
of common stock in conjunction with convertible
|
|||||||
debenture
conversion
|
$
|
14,551,466
|
$
|
143,500
|
|||
Sale
of Series A Preferred Stock and mandatorily converted
|
|||||||
to
common shares
|
$
|
--
|
$
|
14,310,057
|
|||
Issuance
of below market stock options in satisfaction of
|
|||||||
accounts
payable and accrued expenses
|
$
|
--
|
$
|
1,332,052
|
|||
Increase
in receivable included in other current assets in
|
|||||||
connection
with short-term refinancing of long-term debt
|
$
|
--
|
$
|
79,480
|
|||
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
|
$
|
--
|
11.
|
Transactions
with Related Party
|
At
April
30, 2006, the Company has agreed to accept a reduction in amounts due as
executive compensation in satisfaction of amounts due from related party
in the
amount of $415,828. Prior to this agreement, the Company’s change in “Due from
Related Party” for the nine months ended April 30, 2006 represented only the
effect of change in exchange rate for the nine months ended versus that in
effect at July 31, 2005.
12.
|
Stockholders’
Equity
|
In
August
2005, the Company issued 265,929 shares of common stock to various consultants
for services rendered in the amount of $157,289. The shares were valued at
$0.59
to $0.61 per share based on the quoted market price of the Company’s common
stock on the dates of the issuances.
In
September 2005, the Company issued 162,933 shares of common stock to various
vendors for the satisfaction of $113,605 of accounts payable and accrued
liabilities. The shares were valued at $0.81 per share based on the quoted
market price of the Company’s common stock on the dates of the
issuances.
21
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
12. |
Stockholders’
Equity (Continued)
|
In
September 2005, the Company and each of the holders of the $4 million
convertible debenture entered into an Amendment No. 2 to Securities Purchase
Agreement and Registration Rights Agreement pursuant to which the investors
agreed to exercise an additional $2,000,000 in principal amount of Additional
Investment Rights (AIR) (“Second $2 Million Convertible Debenture”). In
connection with this investment, the Company agreed to issue warrants to
purchase an aggregate of 2,439,024 shares of the Company’s common stock at the
exercise price of $0.82 per share exercisable for five years commencing six
months following the issuance thereof and to grant each investor further
AIR. In
addition, in connection with the transaction contemplated by Amendment No.
2,
the Company issued a placement agent (i) 170,732 shares of common stock in
lieu
of a cash fee equal to 7 percent of the gross proceeds received by the Company
and (ii) warrants exercisable into approximately 60,000 shares of common
stock
at the same exercise price as the AIR warrants (see Note 6).
In
October 2005 one of the debenture holders exercised its additional investment
right “AIR Exercise” resulting in a $500,000 convertible promissory note
(“$500,000 Convertible Debenture’) for an aggregate proceeds of $500,000. In
connection with this investment, the Company agreed to issue warrants to
purchase an aggregate of 609,756 shares of the Company’s common stock at the
exercise price of $0.82 per share exercisable for five years commencing six
months following the issuance thereof. In addition, in connection with the
transaction, the Company issued a placement agent warrants to purchase 15,000
shares of common stock (see Note 6).
In
October 2005, the Company issued an aggregate of 909,756 warrants to certain
debenture holders as an incentive to exercise their existing warrants. All
warrants have a five year term, an exercise price of $1.20 per share and
were
valued at $0.63. The warrants, which were valued using the Black-Scholes
pricing
model with expected volatility of 93.22 percent and risk free interest of
3.76
percent, resulted in charges to the interest expense of $573,146.
In
October 2005, the Company issued an aggregate of 2,748,780 warrants to certain
debenture holders as an incentive to exercise their existing warrants. All
warrants have a five year term, an exercise price of $1.25 per share and
were
valued at $0.91. The warrants, which were valued using the Black-Scholes
pricing
model with expected volatility of 93.22 percent and risk free interest of
3.76
percent, resulted in charges to the interest expense of $2,501,390.
In
October 2005, the Company received aggregate cash proceeds of approximately
$6,891,998. The Company issued 8,404,876 shares of common stock as a result
of
these transactions.
In
November 2005, the Company issued 83,787 shares of common stock to consultants
for services rendered in the amount of $81,274. The shares were valued at
$0.97
per share based on the quoted market price of the Company’s common stock on the
dates of the issuances.
22
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
12.
|
Stockholders’
Equity (Continued)
|
In
December 2005, the Company and each of the holders of the $4 million convertible
debenture entered into an Amendment No. 2 to Securities Purchase Agreement
and
Registration Rights Agreement pursuant to which (i) all but one of the Investors
agreed to exercise an aggregate of $1,500,000 in principal amount of the
Additional AIRs granted to such Investors in connection with the First AIR
Exercise and (ii) all of the Investors agreed to exercise an aggregate of
$2,000,000 in principal amount of the Additional AIRs granted to the Investors
in connection with the Second AIR Exercise (“$3.5 Million Convertible
Debenture”). In connection with the $3.5 Million Convertible Debenture, the
Company agreed to issue warrants to purchase an aggregate of 4,268,292 shares
of
the Company’s common stock at the exercise price of $0.82 per share exercisable
for five years commencing six months following the issuance thereof and to
grant
each investor further AIR. In addition, in connection with the transaction
contemplated by Amendment No. 2, the Company issued a placement agent (i)
224,000 shares of common stock in lieu of a cash commission and (ii) warrants
exercisable into approximately 105,000 shares of common stock at the same
exercise price as the AIR warrants (see Note 6).
In
December 2005, the Company issued an aggregate of 1,829,268 warrants to certain
debenture holders as an incentive to exercise their existing warrants. All
warrants have a five year term, an exercise price of $1.25 per share and
were
valued at $0.61. The warrants, which were valued using the Black-Scholes
pricing
model with expected volatility of 0.9254 percent and risk free interest of
4.02
percent, resulted in charges to the interest expense of $1,115,853.
In
January 2006, the Company and each of the holders of the $4 million convertible
debenture entered into an Amendment No. 4 to Securities Purchase Agreement
and
Registration Rights Agreement pursuant to which the investors agreed to exercise
an additional $4,000,000 in principal amount of Additional Investment Rights
(AIR) (“Second $4 Million Convertible Debenture”). In connection with this
investment, the Company agreed to issue warrants to purchase an aggregate
of
3,809,524 shares of the Company’s common stock at the exercise price of $1.05
per share exercisable for five years commencing six months following the
issuance thereof and to grant each investor further AIR. In addition, in
connection with the transaction contemplated by Amendment No. 2, the Company
issued a placement agent (i) 266,667 shares of common stock in lieu of a
cash
fee equal to 7 percent of the gross proceeds received by the Company and
(ii)
warrants exercisable into approximately 120,000 shares of common stock at
the
same exercise price as the AIR warrants (see Note 6).
In
January 2006, the Company issued an aggregate of 3,658,536 warrants to certain
debenture holders as an incentive to exercise their existing warrants. All
warrants have a five year term, an exercise price of $1.60 per share and
were
valued at $0.85. The warrants, which were valued using the Black-Scholes
pricing
model with expected volatility of 0.9210 percent and risk free interest of
4.23
percent, resulted in charges to the interest expense of $3,109,756.
In
February 2006, the Company issued 140,115 shares of common stock valued at
$126,104 as employee compensation.
In
February 2006, the Company issued 50,000 shares of common stock to a consultant
for services rendered in the amount of $76,500. The shares were valued at
$1.53
per share based on the quoted market price of the Company’s common stock on the
dates of the issuances.
23
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
12.
|
Stockholders’
Equity (Continued)
|
In
February 2006, the holders of the Second $4 million convertible debenture
exercised their additional investment right “AIR Exercise” resulting in
$4,000,000 in principal amount of convertible debentures (“Third $4 Million
Convertible Debenture”). In connection with this investment, the Company agreed
to issue warrants to purchase an aggregate of 3,200,000 shares of the Company’s
common stock at the exercise price of $1.25 per share exercisable for five
years
commencing six months following the issuance thereof and to grant each investor
further AIR (see Note 6).
In
February 2006, the Company issued an aggregate of 4,770,617 warrants to certain
debenture holders as an incentive to exercise their existing warrants. All
warrants have a five year term, an exercise price of $3.00 per share and
were
valued at $1.74. The warrants, which were valued using the Black-Scholes
pricing model with expected volatility of 0.9380 percent and risk free interest
of 4.49 percent, resulted in charges to the interest expense of
$8,307,606.
In
March
2006, the Company issued 75,000 shares of common stock to various consultants
for services rendered in the amount of $189,500. The shares were valued at
$2.31
to $2.96 per share based on the quoted market price of the Company’s common
stock on the dates of the issuances.
In
March
2006, the Company issued 2,390 shares of common stock to a vendor for the
satisfaction of $1,959 of accounts payable. The shares were valued at $3.20
per
share based on the quoted market price of the Company’s common stock on the
dates of the issuances. This conversion resulted in a charge of $5,689 to
loss
on extinguishment of debt that represents the difference between quoted market
price of the Company’s common stock and accounts payable balance.
In
March
2006, the Company issued an aggregate of 800,000 warrants to certain debenture
holders as an incentive to exercise their existing warrants. All warrants
have a five year term, an exercise price of $3.00 per share and were valued
at
$1.62. The warrants, which were valued using the Black-Scholes pricing
model with expected volatility of .9377percent and risk free interest of
4.49
percent, resulted in charges to the interest expense of $1,293,953.
In
April
2006, the Company issued 38,400 shares of common stock to various consultants
for services rendered in the amount of $102,528. The shares were valued at
$2.67
per share based on the quoted market price of the Company’s common stock on the
date of the issue.
In
April
2006, the Company issued 204,465 shares of common stock to an investor in
a
private placement for the proceeds of $255,581. The amount was included in
accounts payable and accrued liabilities prior to the finalization of the
terms
of the private placement.
In
April
2006, the Company issued an aggregate of 70,000 warrants to employees of
the
Company. All warrants have a five year term, an exercise price of $2.66 per
share and were valued at $1.96. The warrants, which were valued using the
Black-Scholes pricing model with expected volatility of 92.89 percent and
risk
free interest of 4.77 percent, resulted in charges to operations of
$137,200.
During
the nine months ended April 30, 2006, the Company issued an aggregate of
2,491,846 shares of common stock as monthly principal and interest payments
totaling $1,600,106 of convertible debentures (see Note 6).
24
GENEREX
BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
12.
|
Stockholders’
Equity (Continued)
|
During
the nine months ended April 30, 2006, the Company issued an aggregate of
17,064,582 shares of common stock resulting from the conversion of $11,767,829
of principal and accrued interest of convertible debentures (see Note
6).
During
the nine months ended April 30, 2006, the Company received aggregate cash
proceeds of $3,174,554 from exercises of stock options. The Company issued
2,317,672 shares of common stock as a result of these transactions.
During
the nine months ended April 30, 2006, the Company received aggregate cash
proceeds of $32,819,118 from exercises of stock warrants. The Company issued
32,750,438 shares of common stock as a result of these
transactions.
The
issuances of common stock as described above are summarized as
follow:
|
Additional
|
Total
|
|||||||||||
Common
Stock
|
Paid-In
|
Stockholders’
|
|||||||||||
Shares
|
Amount
|
Capital
|
Equity
|
||||||||||
Convertible
Debenture Conversions
|
17,064,582
|
$
|
17,065
|
$
|
25,318,446
|
$
|
25,335,511
|
||||||
Convertible
Debenture Monthly
|
|||||||||||||
Repayments
|
2,491,846
|
2,492
|
2,747,929
|
2,750,421
|
|||||||||
Warrants
and Stock Options Exercised
|
|||||||||||||
for
Cash
|
35,059,931
|
35,060
|
35,958,613
|
35,993,673
|
|||||||||
Cashless
Exercise of Warrants
|
8,179
|
8
|
(8
|
)
|
-- | ||||||||
Issuance
for Services and Accounts
|
|||||||||||||
Payable
|
1,544,303
|
1,544
|
1,601,848
|
1,603,392
|
|||||||||
Issuance
as Compensation
|
140,115
|
140
|
125,964
|
126,104
|
|||||||||
Total
|
56,308,956 |
$
|
$56,309
|
$
|
$65,752,792
|
$
|
$65,809,101
|
13.
|
Subsequent
Events
|
During
May 2006, the Company refinanced certain long-term debt with a balance at
April
30, 2006 in the amount of $658,557. The significant terms of refinancing
include
interest at 7.6 percent per annum and maturing May 2010.
In
June
2006, the Company issued an aggregate of 3,414,636 shares and 2,560,980 warrants
to purchase its common stock at $2.45 per share to four investors for aggregate
gross proceeds of 7 million.
In
June
2006, the Company issued an aggregate of 3,273,144 warrants to certain debenture
holders as an incentive to exercise their existing warrants. All warrants
have a
five year term, an exercise price of $2.35 per share and were valued at $1.39.
The warrants, which were valued using the Black-Scholes pricing model with
expected volatility of 0.9302 percent and risk free interest of 4.98 percent,
resulted in charges to the interest expense of $4,549,670.
25
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
As
used
herein, the terms the “Company,” “Generex,” “we,” “us,” or “our” refer to
Generex Biotechnology Corporation, a Delaware corporation.
Forward-Looking
Statements
We
have
made statements in this Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
and
elsewhere in this Quarterly Report on Form 10-Q of Generex Biotechnology
Corporation for the fiscal quarter ended April 30, 2006 that may constitute
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 (the "Act"). The Act limits our liability in
any
lawsuit based on forward-looking statements that we have made. All statements,
other than statements of historical facts, included in this Quarterly Report
that address activities, events or developments that we expect or anticipate
will or may occur in the future, including such matters as our projections,
future capital expenditures, business strategy, competitive strengths, goals,
expansion, market and industry developments and the growth of our businesses
and
operations, are forward-looking statements. These statements can be identified
by introductory words such as "expects," "plans," "intends," "believes," "will,"
"estimates," "forecasts," "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:
|
Ÿ
|
our
expectations concerning product candidates for our
technologies;
|
|
Ÿ
|
our
expectations concerning existing or potential development and license
agreements for third-party collaborations and joint
ventures;
|
|
Ÿ
|
our
expectations of when different phases of clinical activity may commence
or
be completed;
|
|
Ÿ
|
our
expectations of when regulatory submissions may be filed or when
regulatory approvals may be received; and
|
|
Ÿ
|
our
expectations in respect of the timing and results of commercialization
activities.
|
Any
or
all of our forward-looking statements may turn out to be wrong. They may be
affected by inaccurate assumptions that we might make or by known or unknown
risks and uncertainties. Actual outcomes and results may differ materially
from
what is expressed or implied in our forward-looking statements. Among the
factors that could affect future results are:
|
Ÿ
|
the
inherent uncertainties of product development based on our new and
as yet
not fully proven technologies;
|
|
Ÿ
|
the
risks and uncertainties regarding the actual effect on humans of
seemingly
safe and efficacious formulations and treatments when tested
clinically;
|
|
Ÿ
|
the
inherent uncertainties associated with clinical trials of product
candidates;
|
|
Ÿ
|
the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product candidates;
|
|
Ÿ
|
the
inherent uncertainties associated with commercialization of products
that
have received regulatory approval; and
|
|
Ÿ
|
our
ability to obtain the necessary financing to fund our
operations.
|
Additional
factors that could affect future results are set forth in Part
I, Item 1. Business - Certain Additional Risk Factors
of our
Annual Report on Form 10-K for the year ended July 31, 2005 and in Part
II, Item 1A. Risk Factors
of this
Quarterly Report on Form 10-Q. We caution investors that the forward-looking
statements contained in this Quarterly Report must be interpreted and understood
in light of conditions and circumstances that exist as of the date of this
Quarterly Report. We expressly disclaim any obligation or undertaking to update
or revise forward-looking statements to reflect any changes in management's
expectations resulting from future events or changes in the conditions or
circumstances upon which such expectations are based.
26
Corporate
History
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 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., a previously 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.
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.
Business
History
We
are
engaged primarily in the research and development of drug delivery 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.
Our
first
product is an insulin formulation that is administered as a fine spray into
the
oral cavity using a hand-held aerosol spray applicator. Between January 1999
and
September 2000, we conducted limited clinical trials on this product in the
United States, Canada and Europe. In September 2000, we entered into an
agreement (the "Development and License Agreement") to develop this product
with
Eli Lilly and Company ("Lilly"). To date, over 1,100 patients with diabetes
have
been dosed with our oral insulin product at approved facilities in seven
countries. We conducted several clinical trials with insulin supplied by Lilly
under our Development and License Agreement. Lilly did not, however, authorize
or conduct any clinical trials or provide financial support for those trials.
We
did receive a $1,000,000 upfront payment from Lilly. On May 23, 2003, we
announced that we had agreed with Lilly to end the Development and License
Agreement for the development and commercialization of buccal delivery of
insulin. On November 5, 2003, we entered into a termination agreement with
Lilly
terminating the Development and License Agreement, effective as of June 2,
2003.
In accordance with the termination agreement, we retained all of the
intellectual property and commercialization rights with respect to buccal spray
drug delivery technology, and we have the continuing right to develop and
commercialize the product. We also entered into a Bulk Supply Agreement (the
"Bulk Supply Agreement") for the sale of human insulin crystals by Lilly to
us
over a three-year period.
In
January 2001, we established 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"), 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,
for
the treatment of prostate cancer, endometriosis and/or the suppression of
testosterone and estrogen. In January 2002, we and Elan agreed to expand the
joint venture to encompass the buccal delivery of morphine for the treatment
of
pain and agreed to pursue buccal morphine as the initial pharmaceutical product
for development under Generex (Bermuda) Ltd., the entity through which the
joint
venture was being conducted. This expansion of the joint venture occurred after
we successfully completed a proof of concept clinical study of morphine delivery
using our proprietary buccal delivery technology.
27
On
December 27, 2004, we entered into an agreement (the "Termination Agreement")
with Elan, whereby we and Elan agreed to terminate the joint venture through
Generex (Bermuda) Ltd. Under the Termination Agreement, all rights granted
by
each party to the other terminated, and each party retained its intellectual
property rights. We obtained full ownership of Generex (Bermuda).
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.
Our
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). Our
immunomedicine products are based on two platform technologies that were
discovered by a former executive officer of Antigen, the Ii-Key hybrid peptides
and Ii-Suppression. Phase 1 clinical testing in humans has commenced at The
Walter Reed Army Medical Center in respect of a vaccine designed to stimulate
an
immune response against the tumor-causing gene HER-2/neu,
which
occurs in a significant percentage of patients with breast cancer as well as
other cancers. The other immunomedicine products, including a vaccine for avian
influenza, are in the pre-clinical stage of development, and trials in human
patients are not expected for at least six months. Development efforts are
underway in melanoma, breast cancer, prostate cancer, HIV, the avian influenza
virus, smallpox, SARS and Type I diabetes mellitus. We are establishing
collaborations with clinical investigators at academic centers to advance the
technology, with the ultimate goal of conducting human clinical testing.
With
the
commencement of commercial sales of our oral insulin product, Generex Oral-lyn™,
in Ecuador in the fourth quarter of our fiscal 2006, we expect to receive
revenues from product sales in the current calendar year. We do not expect
this
revenue to be sufficient for all of our cash needs during the year. In the
past
we were able to fund Antigen expenses with some revenue from research grants
for
Antigen's immunomedicine products. During the fiscal quarter ended April 30,
2006, we received a total of $43,750 in such research grants, and we have
received a total of $131,250 in such grants in fiscal 2006. 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 capital raised through debt
and
equity financings.
Disclosure
Regarding Research and Development Projects
Our
major
research and development projects (in addition to the Antigen Express projects
referenced above) are the refinement of our platform buccal delivery technology,
our buccal insulin project (Generex Oral-lyn™),our buccal morphine product, our
buccal glucose project (Glucose RapidSpray™, an over-the-counter confectionary),
and our buccal metoformin project (metformin gum).
Our
insulin product is in clinical trials. During the last fiscal year, we did
not
expend resources to further our buccal morphine product. In Canada, we are
in
the process of finalizing work for a New Drug Submission (NDS) to the Biologics
and Genetic Therapeutics Directorate of Health Canada for approval for the
marketing and sale of Generex Oral-lyn™ in Canada. We expect that the NDS will
be a blueprint for similar applications to the United States Food and Drug
Administration (FDA) and the European Agency for the Evaluation of Medicinal
Products (EMEA) however we cannot predict at this time when such applications
will be made, what additional work will be required by us before such
applications are granted, how long such work will take, or how much funding
will
be required to complete such work.
Our
insulin product, Generex Oral-lyn™, was approved for commercial sale by drug
regulatory authorities in Ecuador in early May 2005 for the treatment of
patients with either Type-1 or Type-2 diabetes mellitus.. It is our intention
that our South American joint venture partner, PharmaBrand S.A., will handle
the
commercial production and sale of Generex Oral-lyn™ in Ecuador. Commercial sales
of Generex Oral-lyn™ began in Ecuador in the forth quarter of our current fiscal
year.
28
Because
of various uncertainties, we cannot predict the timing of completion and
commercialization of our buccal insulin product or the other products presently
under development. These uncertainties include the success of current studies,
our ability to obtain the required financing, the time required to obtain
regulatory approval even if our research and development efforts are completed
and successful, and the availability of and our access to production facilities
and distribution channels. 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.
Therefore, in the past, 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 is expected to benefit all of
our
potential products. During the nine months ended April 30, 2006, approximately
80% of our $3,628,732 in research expenses was attributable to insulin and
platform technology development, and did not spend any money on morphine and
fentanyl projects. In the comparable period ended April 30, 2005, approximately
85% of our $6,586,764 of research and development was expended for insulin
and
platform technology, and approximately 1% for morphine and fentanyl.
Approximately
20% or $736,972 of our research and development expenses for the nine months
ended April 30, 2006 were related to Antigen's immunomedicine products compared
to approximately 14% or $936,223 for the same period last year. Because these
products are in a very early, pre-clinical stage of development (other than
the
breast cancer vaccine which is in Phase 1 trials), 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 the Antigen Express is
technology, or when products from this technology might begin producing
revenues.
Developments
in Fiscal Quarter Ended April 30, 2006
Amendments
of Outstanding Warrants
On
February 27, 2006, we and the four accredited investors under the November
10,
2004 Securities Purchase Agreement (the “Securities Purchase Agreement”) amended
the terms of certain outstanding warrants to purchase common stock issued in
connection with the Securities Purchase Agreement, as amended, (the “February
Exercised Warrants”) to accelerate the exercise date to February 27, 2006 in
consideration of the full and immediate exercise thereof. The February Exercised
Warrants consisted of warrants issued: (i) to Omicron Master Trust (“Omicron”)
on July 22, 2005 for 243,902 shares of our common stock at $0.82 per share
and
then currently exercisable; (ii) to Cranshire Capital, L.P. (“Cranshire”) on
October 20, 2005 for 300,000 shares of our common stock at $1.20 per share
(originally exercisable on April 20, 2006); (iii) to Iroquois Capital, L.P.
(“Iroquois”) on October 20, 2005 for 609,756 shares of our common stock at $1.20
per share (originally exercisable on April 20, 2006); (iv) to Cranshire on
October 27, 2005 for 309,756 shares of our common stock at $1.25 per share
(originally exercisable on April 27, 2006); (v) to Omicron and Smithfield
Fiduciary LLC (“Smithfield”) on October 27, 2006 for 609,756 shares each of our
common stock at $1.25 per share (originally exercisable on April 27, 2006);
(vi)
to each of the investors on October 27, 2005 for 304,878 shares each of our
common stock at $1.25 per share (originally exercisable on April 27, 2006);
(vii) to Cranshire on December 9, 2005 for 1,829,268 shares of our common stock
at $1.25 per share (originally exercisable on June 9, 2006); and (viii) to
each
of the investors on January 20, 2006 for 952,381 shares each of our common
stock
at $1.05 per share (originally exercisable on July 20, 2006).
The
investors agreed to immediately exercise 100% of the February Exercised Warrants
(for aggregate gross proceeds to us of $11,014,267) in exchange for (a) the
acceleration of the exercise periods and (b) the issuance of additional warrants
equal to 50% of the February Exercised Warrants (an aggregate of 4,770,617
shares) (the “February Inducement Warrants”). The February Inducement Warrants
have an exercise price of $3.00 per share and will be exercisable for five
years
commencing on August 27, 2006.
29
Exercise
of A4 Additional AIRs
On
February 28, 2006, we amended the terms of the Additional Investment Rights
(the
“A4 Additional AIRs”) previously granted to the investors in connection with
Amendment No. 4 to the Securities Purchase Agreement entered into on January
19,
2006 (“Amendment No. 4”) to accelerate the initial exercise date thereof to
February 28, 2006 in consideration of the full and immediate exercise thereof
by
the investors.
In
connection with the exercise of each A4 Additional AIR, each investor purchased
a $1,000,000 principal amount debenture with a conversion price of $1.25
(collectively, the “A4 Additional AIR Debentures”) and warrants (collectively,
the “A4 Additional AIR Warrants”) entitling the investor to purchase a number of
shares of our common stock equal to 100% of the shares of common stock issuable
upon the conversion in full of the A4 AIR Debenture at a conversion price of
$1.25 (subject to adjustment as set forth therein) (without regard to any
restrictions on conversion therein contained) at an exercise price of $1.25.
Accordingly, we issued to the investors A4 Additional AIR Debentures in the
aggregate amount of $4,000,000 and A4 Additional AIR Warrants to purchase an
aggregate of 3,200,000 shares of our common stock, exercisable for five years
commencing six months following the issuance thereof. We received proceeds
of
approximately $4,000,000 in connection with the investors’ exercise of their A4
Additional AIRs.
The
A4
Additional AIR Debentures have a term of fifteen months and amortize over
thirteen months in thirteen equal monthly installments beginning on the first
day of the third month following their issuance. Interest on the principal
amount outstanding accrues at a rate of 6% per annum. We may pay principal
and
accrued interest in cash or, at our option, in shares of our common stock.
If
the we elect to pay principal and interest in shares of our common stock, the
value of each share of common stock will be equal to the lesser of (i) $1.25
and
(ii) ninety percent (90%) of the average of the daily volume weighted average
price for the common stock over the twenty trading day period immediately
preceding the date of payment. At the option of the holder of each A4 Additional
AIR Debenture, the principal amount outstanding under each A4 Additional AIR
Debenture is initially convertible at any time after the closing of Amendment
No
4 into shares of our common stock at a conversion price of $1.25.
Upon
the
occurrence of an “Event of Default” with respect to the A4 Additional AIR
Debentures, the full principal amount of each such Debenture, together with
interest and other amounts owing in respect thereof, may be accelerated at
the
holder’s option and payable in cash. The aggregate amount payable upon an Event
of Default will be equal to the “Mandatory Prepayment Amount,” which shall be
calculated for the A4 Additional AIR Debentures in the same manner as described
below with respect to the A2 AIR Debenture under Financial
Condition, Liquidity and Resources -
Second AIR Exercise Pursuant to Amendment No. 2.
The
A4
Additional AIR Warrants issued to the investors on February 28, 2006 are
initially exercisable into an aggregate of 3,200,000 shares of our common stock,
and the initial exercise price of each A4 Additional AIR Warrant is equal to
$1.25. The conversion price of the A4 Additional AIR Debentures and the exercise
price of the A4 Additional AIR Warrants are each subject to an anti-dilution
adjustment upon the issuance by us of securities at a price per share less
than
the then conversion price or exercise price, as applicable.
On
March
6, 2006, we agreed with the investors to amend the terms of A4 Additional AIR
Warrants to accelerate the exercise dates thereunder in respect of fifty percent
(50%) of the shares of our common stock issuable thereunder (an aggregate of
1,600,000 shares) to March 6, 2006. The A4 Additional AIR Warrants were
initially exercisable on August 31, 2006. The investors agreed to immediately
exercise fifty percent (50%) of the A4 Additional AIR Warrants (for aggregate
gross proceeds to the Company of $2,000,000) in exchange for (a) the
acceleration of the exercise period (insofar as it applied to fifty percent
(50%) of the stock issuable thereunder, and (b) the issuance of additional
warrants equal to 50% of the exercised A4 Additional AIR Warrants (an aggregate
of 800,000 shares). The new warrants have an exercise price of $3.00 per share
and will be exercisable for five years from September 6, 2006.
30
Developments
Subsequent to Fiscal Quarter Ended April 30, 2006
On
June
1, 2006, we entered into a Securities Purchase Agreement with four accredited
investors for the sale of shares of our common stock and warrants in a private
placement for an aggregate purchase price of $7.0 million. These transactions
closed on June 2, 2006.
Pursuant
to the Securities Purchase Agreement, each of Cranshire, Iroquois, Smithfield
and Rockmore Investment Master Fund Ltd. ("Rockmore") purchased 853,659
restricted shares of the our common stock (the "Shares") and warrants to
purchase 640,245 shares of common stock at an exercise price of $2.45 per share
(the "Related Warrants"). The purchase price for each Unit consisting of one
share and .75 warrants was $2.05. Consequently, each investor paid an aggregate
of $1,750,000.95.
Pursuant
to the Securities Purchase Agreement, we agreed to file a registration statement
under the Securities Act of 1933, as amended (the "Securities Act"), to register
the re-sale by the investors of the Shares and the shares of common stock
issuable upon exercise of the Related Warrants. In the Securities Purchase
Agreement, we also granted the investors certain participation rights pursuant
to which, upon any financing at any time within the next twelve months, the
investors will have the right to purchase up to 100% of such financing.
The
exercise price of the Related Warrants is subject to certain 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.
On
June
1, 2006, we agreed with the investors to amend the terms of outstanding warrants
to purchase an aggregate of 4,364,190 shares of common stock (the "Outstanding
Warrants") to accelerate their exercise periods to June 1, 2006. The Outstanding
Warrants included warrants to purchase an aggregate of 4,364,190 shares of
our
common stock with strike prices of $1.25 and $1.60 per share and exercise dates
of August 28, 2006 and July 23, 2006. These Outstanding Warrants included
warrants for 292,408 shares exercisable at $1.60 per share and warrants for
127,880 shares exercisable at $1.25 per share originally issued to Omicron
which
had been assigned to Rockmore. Each of the investors agreed to immediately
exercise the full amount of its Outstanding Warrants. In consideration of the
investors' exercise of the Outstanding Warrants, we issued to each investor
additional warrants exercisable for a period of five years entitling the holder
thereof to purchase a number of shares of common stock equal to 75% of the
shares of common stock issuable upon the conversion in full (without regard
to
any restrictions on conversion therein contained) of the Outstanding Warrants
(an aggregate of 3,273,144 shares of common stock) at an exercise price of
$2.35
per share.
Results
of Operations
Three
and Nine Months Ended April 30, 2006 Compared to Three and Nine Months Ended
April 30, 2005
Our
net
loss for the quarter ended April 30, 2006 was $31,773,494 versus $4,696,670
in
the corresponding quarter of the prior fiscal year. The increase in net loss
in
this fiscal quarter versus the corresponding quarter of the prior fiscal year
is
primarily due to an increase in interest expense and loss on extinguishment
of
debt incurred in connection with convertible debentures. Our operating loss
for
the quarter increased to $3,890,499 compared to $3,324,521 in the third fiscal
quarter of 2005. The increase is a result of the higher research and development
expenses ($1,635,238 versus $1,009,799 last year) despite a moderate decrease
in
our general and administrative expenses (to $2,299,011 from
$2,358,472).
The
increase in research and development expenses for the fiscal quarter ending
April 30, 2006 reflects an increased level of research and development
activities in respect of our buccal delivery technologies including
pre-commercialization activities of our buccal insulin product in Ecuador.
Expenses associated with clinical and regulatory consultants also contributed
to
higher research and development costs this quarter. The increase in expenses
was
slightly offset by a small reduction in research and development activities
of
Antigen Express.
The
small
decrease in general and administrative expenses for the third fiscal quarter
of
2006 is result of the decrease in financial services and audit and accounting
expenses despite the increase in legal, consulting advertising and travel
expenses and higher executive compensation.
Our
interest expense in the third fiscal quarter of 2006 increased to $17,227,595
compared to interest expense of $1,403,667 in the third fiscal quarter of 2005
due to interest paid in connection with convertible debentures entered during
last fiscal year and current quarter and interest expense associated with the
value of warrants issued to convertible debenture holders as an incentive to
exercise their existing warrants. Our interest and income from rental operations
increased to $283,559 in the third fiscal quarter of 2006 compared to $31,518
in
the same quarter last year due to the reallocation of certain properties to
rental operations and larger balances and higher interest earned on short term
investments. In addition, this fiscal quarter we incurred $10,938,959 in losses
on extinguishment of debt in connection with monthly amortization payments
due
on convertible debentures which amount represents the difference between the
quoted market price of our stock and a 10% discount to the average of the 20-day
VWAP that was used to determine the number of shares issued.
31
Financial
Condition, Liquidity and Resources
To
date
we have financed our development stage activities primarily through private
placements of our common stock and securities convertible into our common stock.
During
the nine months ended April 30, 2006, we engaged in several capital-raising
transactions with certain of our stockholders as described above and below
under
the caption Developments
in Fiscal Quarter Ended April 30, 2006
in this
Part
I - Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations,
and as
described in our Quarterly Report on Form 10-Q for the fiscal quarter ended
January 31, 2006. At April 30, 2006, we had cash and short-term investments
of
approximately $42 million, an increase of approximately $41 million from the
balance as of the end of the prior fiscal year. The increase is attributable
to
the proceeds received in connection with warrant and additional investment
right
exercises during nine month of our fiscal 2006. At April 30, 2006, we believed
that our anticipated cash position was sufficient to meet our working capital
needs for the next 12 months based on the pace of our planned activities. Beyond
that, we will likely require additional funds to support our working capital
requirements or for other purposes. From time to time as deemed appropriate
by
management, we may seek to raise funds through private or public equity
financing or from other sources. If we are unable to raise additional capital
as
needed, we could be required to "scale back" or otherwise revise our business
plan. Any significant scale back of operations or modification of our business
plan due to a lack of funding could be expected to affect our prospects
materially and adversely.
At
April
30, 2006, we had 6% Secured Convertible Debentures (the “Debentures”)
outstanding in the aggregate principal amount of $1,373,077, which were issued
in connection with the Securities Purchase Agreement and the amendments thereto.
At such date, we had issued an aggregate of 19,556,428 shares of common stock
resulting from the conversion of an aggregate of $13,367,935 of Debenture
principal and accrued interest issued under the auspices of the Securities
Purchase Agreement, as amended.
At
April
30, 2006, we had 14,896,230 outstanding warrants and 9,149,597 options to
purchase our common stock.
November
2004 Securities Purchase Agreement
We
entered into the Securities Purchase Agreement on November 10, 2004 and closed
the transaction on November 12, 2004. Pursuant to the Securities Purchase
Agreement, we issued Debentures and related warrants and for an aggregate
purchase price of $4,000,000, which Debentures have since been fully repaid
in
cash or by conversion into shares of our common stock. The warrants issued
in
connection with the Securities Purchase Agreement were initially exercisable
into the same number of shares of the common stock initially issuable upon
conversion of the Debentures. The initial exercise price of each warrant was
equal to 110% of the conversion price of the Debentures, or $0.91. The
conversion price of the Debentures and the exercise price of the warrants were
each subject to an anti-dilution adjustment upon the issuance by us of
securities at a price per share less than the then conversion price or exercise
price, as applicable. The warrants issued in connection with the Securities
Purchase Agreement were fully exercised in late October 2005 as described below
under the caption Exercise
of Outstanding Warrants Issued Pursuant to Securities Purchase
Agreement
at a
reduced exercise price $0.82 per share as a consequence of an anti-dilution
adjustment.
In
connection with the Securities Purchase Agreement, we granted an Additional
Investment Right to holders of the Debentures. Pursuant to the terms of each
Additional Investment Right, each holder had the right at any time prior to
January 24, 2006 to purchase on the same terms and conditions as the private
placement up to the same number of Debentures and warrants purchased by such
holder at the closing of the private placement.
32
In
connection with the Securities Purchase Agreement, we also issued to a placement
agent a warrant exercisable into approximately 145,000 shares of common stock
at
the same exercise price as the warrants issued to the holders of the Debentures.
The
aggregate number of shares of common stock issuable upon conversion or exercise
of the Debentures and related warrants issuable pursuant to the Securities
Purchase Agreement exceeded 19.99% of the outstanding shares of our common
stock
prior to such issuance. Because the rules and regulations of The NASDAQ Stock
Market prohibit, under certain circumstances, the issuance, without prior
stockholder approval, of shares of common stock in excess of 19.99% of an
issuer's outstanding common stock prior to such issuance, certain insiders
entered into a voting agreement with the holders of the Debentures whereby
such
insiders agreed to vote at the next meeting of our stockholders all shares
of
common stock held by them in favor of authorizing the issuance of an amount
of
shares of common stock in excess of 19.99% of the outstanding common stock
prior
to consummating the private placement. The issuance of such shares was approved
by our stockholders at the Annual Meeting of Stockholders held on April 5,
2005.
AIR
Exercise Pursuant to Amendment No. 1
On
June
16, 2005, we and each of the four accredited investor parties to the Securities
Purchase Agreement entered into Amendment No. 1 to the Securities Purchase
Agreement and the Registration Rights Agreement (“Amendment No. 1”), pursuant to
which the investors agreed to exercise of 50% of their additional investment
rights in the aggregate amount of $2,000,000. This transaction closed on June
17, 2005. In consideration for the investors’ exercise of their additional
investment rights (the “A1 Air Exercise”), we issued the investors:
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Debentures
in the aggregate amount of $2,000,000, with a reduced conversion
price
($0.60) (which reduced conversion price did not trigger any anti-dilution
adjustments to the outstanding Debentures and related warrants) (the
“A1
AIR Debentures”);
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warrants
to purchase an aggregate of 2,439,024 shares of our common stock
at an
exercise price of $0.82 per share, which were exercisable for five
years
commencing six months following the issuance thereof (the “A1 AIR
Warrants”); and
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further
additional investment rights (“A1 Additional AIRs”), pursuant to which
each investor had the right to purchase detachable units consisting
of (i)
Debentures in principal amount equal to the principal amount of A1
AIR
Debentures issuable to each investor upon the A1 AIR Exercise with
a
conversion price of $0.82 (the “A1 Additional AIR Debentures”) and (ii)
additional warrants entitling the holder thereof to purchase a number
of
shares of our common stock equal to 100% of the shares of common
stock
issuable upon the conversion in full of the A1 Additional AIR Debentures
at an $0.82 conversion price (subject to adjustment as set forth
therein)
(without regard to any restrictions on conversion therein contained)
at an
exercise price of $0.82 (the “A1 Additional AIR
Warrants”).
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The
A1
AIR Debentures have since been fully converted into shares of our common stock.
The A1 AIR Warrants were amended (to abridge the exercise periods) and exercised
in full in late October 2005 as described below under the caption Exercise
of Outstanding AIR Warrants.
The A1
Additional AIRs were amended (to abridge the exercise periods) and exercised
in
full in December 2005 as described below under Omicron’s
Exercise of Additional AIR and
Third AIR Exercise Pursuant to Amendment No. 3.
In
addition, in connection with the transactions contemplated by Amendment No.
1,
we issued to a placement agent (i) 170,732 shares of common stock in lieu of
a
cash fee equal to 7% of the gross proceeds received by us and (ii) warrants
exercisable into approximately 60,000 shares of our common stock at the same
exercise price as the A1 AIR Warrants.
33
As
we
obtained shareholder approval at our April 5, 2005 Annual Meeting of
Stockholders for the issuance of up to an aggregate of 10,000,000 shares of
common stock or securities convertible into common stock for a price of not
less
than 70% of the market price at the time of issuance and for aggregate
consideration not to exceed $50,000,000, in excess of the number of shares
that
NASDAQ’s Marketplace Rules 4350(i)(1)(c) and (D) permit us to issue without
prior stockholder approval, no further stockholder approval was necessary in
connection with the transactions contemplated by
Amendment No. 1.
Second
AIR Exercise Pursuant to Amendment No. 2
On
September 8, 2005, we and the investor parties to the Securities Purchase
Agreement entered into Amendment No. 2 pursuant to which the investors agreed
to
exercise the remaining $2,000,000 in principal amount of their original
additional investment rights acquired pursuant to the Securities Purchase
Agreement on November 12, 2004 (the “A2 AIR Exercise”). In connection with the
A2 AIR Exercise, we issued the investors:
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Debentures
in the aggregate amount of $2,000,000, with a reduced conversion
price
($0.60) (which reduced conversion price did not trigger any anti-dilution
adjustments to the outstanding Debentures and related warrants) (the
“A2
AIR Debentures”);
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warrants
to purchase an aggregate of 2,439,024 shares of our common stock
at the
exercise price of $0.82 per share, which were exercisable for five
years
commencing six months following the issuance thereof (the “A2 AIR
Warrants”); and
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additional
investment rights (the “A2 Additional AIRs”), pursuant to which each
investor had the right to purchase detachable units consisting of
(i)
Debentures in principal amount equal to the principal amount of A2
AIR
Debentures issuable to each investor upon the A2 AIR Exercise with
a
conversion price of $0.82 (the “A2 Additional AIR Debentures”) and (ii)
additional warrants entitling the holder thereof to purchase a number
of
shares of our common stock equal to 100% of the shares of common
stock
issuable upon the conversion in full of the A2 Additional AIR Debentures
at an $0.82 conversion price (subject to adjustment as set forth
therein)
(without regard to any restrictions on conversion therein contained)
at an
exercise price of $0.82 (the “A2 Additional AIR
Warrants”).
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The
A2
AIR Debentures have since been fully converted into shares of our common stock.
The A2 AIR Debentures have a term of fifteen months and amortize over thirteen
months in thirteen equal monthly installments beginning on the first day of
the
third month following their issuance. Interest on the principal amount
outstanding accrues at a rate of 6% per annum. We may pay principal and accrued
interest in cash or, at our option, in shares of our common stock. If we elect
to pay principal and interest in shares of our common stock, the value of each
share of common stock will be equal to the lesser of (i) the conversion price
($0.60) and (ii) ninety percent (90%) of the average of the daily volume
weighted average price for the common stock for the twenty trading day period
immediately preceding the date of payment. At the option of the holder of each
A2 AIR Debenture, the principal amount outstanding under each A2 AIR Debenture
is convertible at any time into shares of our common stock at a conversion
price
of $0.60.
Upon
the
occurrence of an “Event of Default,” including a default in payment of principal
or interest (including late fees) which is not cured within three trading days,
the full principal amount of each A2 AIR Debenture, together with interest
and
other amounts owing in respect thereof, to the date of acceleration will become,
at the holder’s election, due and payable in cash. The aggregate amount payable
upon an Event of Default shall be equal to the “Mandatory Prepayment Amount.”
The Mandatory Prepayment Amount for any A2 AIR Debentures shall equal the sum
of
(i) the greater of: (A) 130% of the principal amount of A2 AIR Debentures to
be
prepaid, plus all accrued and unpaid interest thereon, or (B) the principal
amount of A2 AIR Debentures to be prepaid, plus all other accrued and unpaid
interest thereof, divided by the conversion price on (x) the date the Mandatory
Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory
Prepayment Amount is paid in full, whichever is less, multiplied by the daily
volume weighted average price of the common stock on (x) the date the Mandatory
Prepayment Amount is demanded or otherwise due or (y) the date the Mandatory
Prepayment Amount is paid in full, whichever is greater, and (ii) all other
amounts, costs, expenses and liquidated damages due in respect of such Second
AIR Debentures. The interest rate on the A2 AIR Debentures will accrue at the
rate of 18% per annum, or such lower maximum amount of interest permitted to
be
charged under applicable law, beginning five days after the occurrence of any
Event of Default that results in the acceleration of the A2 AIR Debentures.
A
late fee of 18% per annum, or such lower maximum amount of interest permitted
to
be charged under applicable law, will accrue on a daily basis on all overdue
accrued and unpaid interest under the A2 AIR Debentures from the due date to
the
date of payment.
34
The
A2
AIR Warrants were amended (to abridge the exercise periods) and exercised in
full in late October 2005 as described below under the caption Exercise
of Outstanding AIR Warrants.
The A2
Additional AIRs were amended (to abridge the exercise periods) and exercised
in
full in December 2005 as described below under Omicron’s
Exercise of Additional AIR
and
Third AIR Exercise Pursuant to Amendment No. 3.
In
addition, in connection with the transactions contemplated Amendment No. 2,
we
issued to a placement agent (i) 170,732 shares of our common stock in lieu
of a
cash fee equal to 7% of the gross proceeds received by us and (ii) warrants
exercisable into approximately 60,000 shares of our common stock at the same
exercise price as the Second AIR Warrants.
Cranshire
and Omicron Notes and Related Warrants
We
entered into a Promissory Note and Agreement with Cranshire on March 28, 2005
and entered into a Promissory Note and Agreement with Omicron on April 6, 2005
pursuant to which Cranshire and Omicron loaned us the principal amounts of
$500,000 and $100,000, respectively (the "Notes"). The outstanding principal
balances under the Notes and any accrued but unpaid interest thereon was due
and
payable on May 15, 2005 to the extent that Cranshire and Omicron had not
exercised their respective conversion rights under the Notes. On April 28,
2005,
as additional consideration for the loans from Cranshire and Omicron, we issued
Cranshire a warrant to purchase an aggregate of 1,219,512 shares of our common
stock at a per share price of $0.82 and issued Omicron a warrant to purchase
an
aggregate of 243,902 shares of our common stock at a per share price of $0.82.
We
did
not pay the outstanding principal balances originally due on May 15, 2005 under
the Notes. Interest on the outstanding principal balances under the Notes began
accruing before the maturity date at the rate of 10% per annum. On June 7 and
July 22, 2005, Cranshire and Omicron agreed to extend the interest payment
date
and the maturity date of each of the Notes, with the last extension to September
20, 2005. In consideration of each such extension, we issued Cranshire a warrant
to purchase an aggregate of 1,219,512 shares of our common stock at a per share
price of $0.82 and issued Omicron a warrant to purchase an aggregate of 243,902
shares of our common stock at a per share price of $0.82
On
September 20, 2005, we did not pay the outstanding principal balances under
the
Notes. On October 19, 2005 Cranshire converted outstanding principal and accrued
interest on its Note ($528,082 in total) into 644,003 shares of our common
stock. On October 27, 2005 Omicron converted outstanding principal and accrued
interest on its Note ($105,644 in total) into 128,834 shares of common stock.
In
October and November 2005, Cranshire exercised the outstanding warrants
previously issued to it in connection with its Note, and, on December 9, 2005,
in consideration thereof, we issued to Cranshire a five-year warrant to purchase
an aggregate of 1,829,268 shares of our common stock at $1.25 per share. On
February 28, 2006, Omicron exercised one of its warrants previously issued
to it
in connection with its Note pursuant to which it purchased an aggregate of
243,902 shares of our common stock for $200,000. In consideration of such
exercise, we issued to Omicron a five-year warrant to purchase an aggregate
of
121,951 shares of our common stock at $3 per share. Prior thereto, Omicron
has
voluntarily exercised all of its other warrants previously issued to it in
connection with its Note for no additional consideration.
35
Exercise
of Outstanding Warrants Issued Pursuant to Securities Purchase
Agreement
On
October 20, 2005, in consideration for the exercise of certain outstanding
warrants previously issued to each of Cranshire and Iroquois in connection
with
their purchase of our Debentures pursuant to the Securities Purchase Agreement,
we issued a five-year warrant to purchase 300,000 shares of our common stock
to
Cranshire and a five-year warrant to purchase 609,756 shares of our common
stock
to Iroquois, in each case with an exercise price of $1.20 per share. We received
aggregate proceeds of $1,492,000 in connection with Cranshire’s partial exercise
of its outstanding warrant to purchase 1,219,512 shares of our common stock
and
Iroquois’ full exercise of its outstanding warrant to purchase 1,219,512 shares
of our common stock.
On
October 27, 2005, in consideration for the exercise of certain outstanding
warrants previously issued pursuant to the Securities Purchase Agreement, we
issued to Cranshire, Omicron and Smithfield five-year warrants to purchase
an
aggregate of 1,529,268 shares of our common stock at $1.25 per share. We
received aggregate proceeds of approximately $2,508,000 in connection with
their
exercise of outstanding warrants to purchase shares of our common stock.
Exercise
of Outstanding AIR Warrants
On
October 26, 2005, we and the holders of the A1 AIR Warrants amended the A1
AIR
Warrants pursuant to which we agreed to accelerate the initial exercise dates
thereof (the 181st day following the date of issuance) in consideration of
the
full and immediate exercise by each of the investors of its A1 AIR Warrant
and
the delivery to us of a Notice of Exercise in respect thereof on or before
the
close of business on October 27, 2005. Each of the investors timely delivered
the aforementioned Notice of Exercise, satisfying the conditions specified
in
each of the A1 AIR Warrant amendments. We received aggregate proceeds of
approximately $2,000,000 in connection with the investors’ exercise of the A1
AIR Warrants. In consideration of the investors’ exercise of the A1 AIR
Warrants, we issued each of the investors a five-year warrant to purchase
304,878 shares of our common stock at $1.25 per share.
Omicron’s
Exercise of Additional AIR
On
October 27, 2005, we and Omicron amended the A1 Additional AIR granted to
Omicron to accelerate the initial exercise date (defined as the 181st day
following the date of issuance) in consideration of the full and immediate
exercise by Omicron of its A1 Additional AIR and the delivery to us of a Notice
of Exercise in respect thereof on or before the close of business on October
27,
2005. Omicron timely delivered its Notice of Exercise, satisfying the conditions
specified in the A1 AIR amendment. In connection with Omicron’s exercise of the
A1 Additional AIR, we received aggregate proceeds of $500,000. Through its
exercise of its A1 Additional AIR, Omicron purchased (i) a $500,000 principal
amount A1 Additional AIR Debenture with a conversion price of $0.82 and (ii)
A1
Additional AIR Warrants entitling Omicron to purchase a number of shares of
our
common stock equal to 100% of the shares of common stock issuable upon the
conversion in full of the A1 Additional AIR Debenture at a $0.82 conversion
price (subject to adjustment as set forth therein) (without regard to any
restrictions on conversion therein contained) at an exercise price of
$0.82
Third
AIR Exercise Pursuant to Amendment No. 3
On
December 4, 2005, we and the four accredited investor parties to the Securities
Purchase Agreement entered into Amendment No. 3 pursuant to which (i) the all
of
the investors except Omicron agreed to exercise an aggregate of $1,500,000
in
principal amount of the A1 Additional AIRs (Omicron had previously exercised
its
A1 Additional AIR as described above), and (ii) all of the investors, including
Omicron, agreed to exercise an aggregate of $2,000,000 in principal amount
of
the A2 Additional AIRs granted to them in connection with Amendment No.
2.
In
connection with Amendment No. 3, we and the investors, excluding Omicron, agreed
to accelerate the initial exercise date of the A1 Additional AIRs (the 181st
day
following the date of issuance) in consideration of the full and immediate
exercise by such investors of their A1 Additional AIRs and the delivery to
us of
Notices of Exercise in respect thereof on or before the close of business on
December 5, 2005. In addition, we and all four of the investors agreed to
accelerate the initial exercise dates of the A2 Additional AIRs (the 181st
day
following the date of issuance) in consideration of the full and immediate
exercise by the investors of their A2 Additional AIRs and the delivery to us
of
Notices of Exercise in respect thereof on or before the close of business on
December 5, 2005.
36
Each
investor timely delivered its Notices of Exercise In connection with the
exercise of each A1 Additional AIR and each A2 Additional AIR on December 5,
2005, each investor purchased a $500,000 principal amount Debenture with a
conversion price of $0.82 (the A1 Additional Debentures and the A2 Additional
Debentures) and a Warrant entitling the investor to purchase a number of shares
of our common stock equal to 100% of the shares of common stock issuable upon
the conversion in full of the A1 Additional AIR Debenture and the A2 Additional
AIR Debenture (together, the “A1/A2 Additional AIR Debentures”) at a $0.82
conversion price (subject to adjustment as set forth therein) (without regard
to
any restrictions on conversion therein contained) at an exercise price of $0.82
per share (the A1 Additional AIR Warrants and the A2 Additional AIR Warrants
(together, the “A1/A2 Additional AIR Warrants”)). Accordingly, we issued to the
investors A1/A2 Additional AIR Debentures in the aggregate principal amount
of
$3,500,000 and A1/A2 Additional AIR Warrants to purchase an aggregate of
4,268,292 shares of our common stock, exercisable for five years commencing
six
months following the issuance thereof. We received proceeds of approximately
$3,500,000 in connection with the investors’ exercise of their A1 Additional
AIRs and their A2 Additional AIRS.
The
A1/A2
Additional AIR Debentures have since been fully converted into shares of our
common stock. The A1/A2 Additional AIR Debentures had a term of fifteen months
and amortized over thirteen months in thirteen equal monthly installments
beginning on the first day of the third month following their issuance. Interest
on the principal amount outstanding accrued at a rate of 6% per annum. The
principal and accrued interest could be repaid in cash or, at our option, in
shares of our common stock. If we elected to pay principal and interest in
shares of our common stock, the value of each share of common stock would be
equal to the lesser of (i) $0.82 and (ii) ninety percent (90%) of the average
of
the daily volume weighted average price for the common stock over the twenty
trading day period immediately preceding the date of payment. At the option
of
the holder of each A1/A2 Additional AIR Debenture, the principal amount
outstanding under each A1/A2 Additional AIR Debenture was convertible at any
time into shares of our common stock at a conversion price of
$0.82.
In
addition, in consideration of each investor’s exercise of its A1 Additional AIRs
and its A2 Additional AIRs, including Omicron’s October 2005 exercise of its A1
Additional AIR, we granted to each investor an additional investment right
(the
“A3 Additional AIRs”) pursuant to which each investor had the right to purchase
detachable units consisting of (a) Debentures in principal amount of $1,000,000
with a conversion price of $1.25 per share (the “A3 Additional AIR Debentures”)
and (b) warrants entitling the holder thereof to purchase a number of shares
of
our common stock equal to 100% of the shares of common stock issuable upon
the
conversion in full of the A3 Additional AIR Debentures at a $1.25 conversion
price (subject to adjustment as set forth therein) (without regard to any
restrictions on conversion therein contained) at an exercise price of $1.25
per
share.
In
addition, in connection with the transactions contemplated by Amendment No.
3
and Omicron’s October 2005 exercise of its A1 Additional AIR, we paid to a
placement agent (i) 224,000 shares of our common stock in lieu of a $280,000
cash fee (7% of the gross proceeds received by us) and (ii) warrants exercisable
into 105,000 shares of common stock at the same exercise price as the A1/A2
Additional AIR Warrants. These shares were also registered for
resale.
The
A1/A2
Additional AIR Warrants were amended (to abridge the exercise periods) and
exercised in full in late December 2005 as described below under the caption
January
2006 Acceleration and Exercise of AIR Warrants.
The A3
Additional AIRs were amended (to abridge the exercise periods) and exercised
in
full in December 2005 as described below under Fourth
AIR Exercise Pursuant to Amendment No. 4.
Exercise
of Warrants in December 2005.
On
December 9, 2005, in consideration for the exercise of certain outstanding
warrants previously issued in connection with its Note, we issued to Cranshire
five-year warrants to purchase an aggregate of 1,829,268 shares of our common
stock at $1.25 per share. We received aggregate proceeds of approximately
$3,000,000 in connection with the warrant exercise.
37
Fourth
AIR Exercise Pursuant to Amendment No. 4
In
connection with Amendment No. 4 entered into on January 19, 2006, the investors
agreed to exercise an aggregate of $4,000,000 in principal amount of the A3
Additional AIRs (being the full amount thereof). Pursuant to each such A3
Additional AIR, each Investor had the right to purchase detachable units
consisting of (a) an A3 Additional AIR Debenture in principal amount of
$1,000,000 with a conversion price of $1.25 and (b) an A3 Additional AIR Warrant
entitling the holder thereof to purchase a number of shares of our common stock
equal to 100% of the shares of common stock issuable upon the conversion in
full
of the A3 additional AIR Debenture at a $1.25 conversion price (subject to
adjustment as set forth therein) (without regard to any restrictions on
conversion therein contained) at an exercise price of $1.25 per
share.
Pursuant
to Amendment No. 4, we amended the terms of the A3 Additional AIRs to accelerate
the initial exercise dates thereof to January 19, 2006 and to reduce the
conversion price from $1.25 to $1.05 in consideration of their full and
immediate exercise by the investors. We received proceeds of approximately
$4,000,000 in connection with the investors’ exercise of their A3 Additional
AIRs.
Accordingly,
we issued to the investors A3 Additional AIR Debentures in the aggregate amount
of $4,000,000 and A3 Additional AIR Warrants to purchase an aggregate of
3,809,524 shares of our common stock, exercisable for five years commencing
six
months following the issuance thereof. Under the terms of Amendment No. 4,
the
reduction in the conversion price of the A3 Additional AIR Debentures and the
exercise price of the A3 Additional AIR Warrants did not trigger any
anti-dilution adjustments to any outstanding securities held by the investors.
With
the
exception of the A3 Additional AIR Debenture held by Cranshire, the A3
Additional AIR Debentures have since been fully converted into shares of our
common stock. The A3 Additional AIR Debentures have a term of fifteen months
and
amortize over thirteen months in thirteen equal monthly installments beginning
on the first day of the third month following their issuance. Interest on the
principal amount outstanding accrues at a rate of 6% per annum. We may pay
principal and accrued interest in cash or, at our option, in shares of our
common stock. If the we elect to pay principal and interest in shares of our
common stock, the value of each share of common stock will be equal to the
lesser of (i) $1.05 and (ii) ninety percent (90%) of the average of the daily
volume weighted average price for the common stock over the twenty trading
day
period immediately preceding the date of payment. At the option of the holder
of
each A3 Additional AIR Debenture, the principal amount outstanding under each
A3
Additional AIR Debenture is convertible at any time into shares of the our
common stock at a conversion price of $1.05.
Upon
the
occurrence of an “Event of Default” with respect to each A3 Additional AIR
Debenture, the full principal amount of each such Debenture, together with
interest and other amounts owing in respect thereof, may be accelerated at
the
holder’s option and payable in cash. The aggregate amount payable upon an Event
of Default will be equal to the “Mandatory Prepayment Amount,” which shall be
calculated for the A3 Additional AIR Debentures in the same manner as described
above with respect to the A2 AIR Debentures under Second
AIR Exercise Pursuant to Amendment No. 2.
In
addition, in consideration of each investor’s exercise of its A3 Additional AIR,
we granted to each investor a further additional investment right (the “A4
Additional AIR”) pursuant to which each investor had the right to purchase
detachable units consisting of (a) a Debenture in principal amount of $1,000,000
with a conversion price of $1.25 (the “A4 Additional AIR Debenture”) and (b) a
warrant entitling the holder thereof to purchase a number of shares of our
common stock equal to 100% of the shares of common stock issuable upon the
conversion in full of the A4 Additional AIR Debenture at a $1.25 conversion
price (subject to adjustment as set forth therein) (without regard to any
restrictions on conversion therein contained) at an exercise price of $1.25
per
share (the “A4 Additional AIR Warrants”). The A4 Additional AIRs were amended
(to abridge the exercise periods) and exercised in full on February 28, 2006
as
described below under Exercise
of A4 Additional AIRs.
Under
the
terms of Amendment No. 4, we also agreed to register for resale the securities
issuable upon conversion/exercise of the A4 Additional AIR Debentures and the
A4
Additional AIR Warrants, consistent with the investors’ existing registration
rights under the Registration Rights Agreement. We agreed to register such
securities on the Registration Statement contemplated by Amendment No. 3. The
Registration Statement became effective on February 24, 2006.
38
In
addition, in connection with the transactions contemplated by Amendment No.
4,
we issued to a placement agent (i) 266,667 shares of common stock in lieu of
a
cash fee equal to 7% of the gross proceeds received by us and (ii) warrants
exercisable into approximately 120,000 shares of common stock at the same
exercise price as the AIR Warrants. These shares were registered for resale
in
the registration statement which became effective on February 24,
2006.
January
2006 Acceleration and Exercise of AIR Warrants
On
January 23, 2006, we agreed with the investors to amend the terms of certain
outstanding warrants to purchase common stock (the “January Exercised Warrants”)
to accelerate their exercise dates to January 23, 2006. The January Exercised
Warrants consisted of warrants for an aggregate of 2,439,024 shares
issued in connection with Amendment No. 2 (initially exercisable on March 8,
2006) and warrants for an aggregate of 4,878,048 shares issued in connection
with Amendment No. 3 (initially exercisable beginning June 5, 2006). The
investors agreed to immediately exercise 100% of these warrants (for aggregate
gross proceeds to the Company of $6,000,000) in exchange for (a) the
acceleration of the exercise period , and (b) the issuance of additional
warrants equal to 50% of the shares issuable upon exercise of the January
Exercised Warrants (an aggregate of 3,658,536 shares) (the “January Inducement
Warrants”). The January Inducement Warrants have an exercise price of $1.60 per
share and will be exercisable for a period of five years commencing six months
from the date of issuance. The exercise price is subject to an anti-dilution
adjustment upon the issuance by us of securities at a price per share less
than
the then exercise price. If, at any time after the first anniversary of the
date
of issuance of the January Inducement Warrants, there is no effective
registration statement registering for resale the shares of common stock into
which the warrants are exercisable, each holder may exercise its warrant through
a cashless exercise. The January Inducement Warrants are included in a
Registration Statement declared effective February 24, 2006. The number of
shares to be issued upon a cashless exercise will be equal to the quotient
resulting from the following calculation: [(the VWAP on the trading day
immediately preceding the date of such election less the exercise price, as
adjusted) multiplied by the number of shares issuable upon exercise of the
warrant by means of a cash exercise] divided by the VWAP on the trading day
immediately preceding the date of such election. Each holder has agreed that
it
will not exercise its warrant if such exercise would cause the holder, together
with its respective affiliates, to beneficially own more than 4.99% of our
common stock then outstanding.
Amendments
of Outstanding Warrants
On
February 27, 2006, we and the investors agreed to amend the terms of certain
outstanding warrants to purchase common stock issued in connection with the
Securities Purchase Agreement, as amended, (the “February Exercised Warrants”)
to accelerate the exercise date to February 27, 2006 in consideration of the
full and immediate exercise thereof. The February Exercised Warrants consisted
of warrants issued: (i) to Omicron on July 22, 2005 for 243,902 shares of our
common stock at $0.82 per share and then currently exercisable; (ii) to
Cranshire on October 20, 2005 for 300,000 shares of our common stock at $1.20
per share (originally exercisable on April 20, 2006); (iii) to Iroquois on
October 20, 2005 for 609,756 shares of our common stock at $1.20 per share
(originally exercisable on April 20, 2006); (iv) to Cranshire on October 27,
2005 for 309,756 shares of our common stock at $1.25 per share (originally
exercisable on April 27, 2006); (v) to Omicron and Smithfield on October 27,
2006 for 609,756 shares each of our common stock at $1.25 per share (originally
exercisable on April 27, 2006); (vi) to each of the investors on October 27,
2005 for 304,878 shares each of our common stock at $1.25 per share (originally
exercisable on April 27, 2006); (vii) to Cranshire on December 9, 2005 for
1,829,268 shares of our common stock at $1.25 per share (originally exercisable
on June 9, 2006); and (viii) to each of the investors on January 20, 2006 for
952,381 shares each of our common stock at $1.05 per share (originally
exercisable on July 20, 2006).
The
investors agreed to immediately exercise 100% of the February Exercised Warrants
(for aggregate gross proceeds to us of $11,014,267) in exchange for (a) the
acceleration of the exercise periods and (b) the issuance of additional warrants
equal to 50% of the February Exercised Warrants (an aggregate of 4,770,617
shares) (the “February Inducement Warrants”). The February Inducement Warrants
have an exercise price of $3.00 per share and will be exercisable for five
years
commencing on August 27, 2006.
39
Exercise
of A4 Additional AIRs
On
February 28, 2006, we amended the terms of the A4 Additional AIRs previously
granted to the investors in connection with Amendment No. 4 to accelerate the
initial exercise date of the A4 Additional AIRs to February 28, 2006 in
consideration of the full and immediate exercise thereof by the
investors.
In
connection with the exercise of each A4 Additional AIR, each investor purchased
a $1,000,000 principal amount debenture with a conversion price of $1.25
(collectively, the “A4 Additional AIR Debentures”) and warrants (collectively,
the “A4 Additional AIR Warrants”) entitling the investor to purchase a number of
shares of our common stock equal to 100% of the shares of common stock issuable
upon the conversion in full of the A4 Additional AIR Debenture at a conversion
price of $1.25 (subject to adjustment as set forth therein) (without regard
to
any restrictions on conversion therein contained) at an exercise price of $1.25.
Accordingly, we issued to the investors A4 Additional AIR Debentures in the
aggregate amount of $4,000,000 and A4 Additional AIR Warrants to purchase an
aggregate of 3,200,000 shares of our common stock, exercisable for five years
commencing six months following the issuance thereof. We received proceeds
of
approximately $4,000,000 in connection with the investors’ exercise of their A4
Additional AIRs.
The
A4
Additional AIR Debentures have a term of fifteen months and amortize over
thirteen months in thirteen equal monthly installments beginning on the first
day of the third month following their issuance. Interest on the principal
amount outstanding accrues at a rate of 6% per annum. We may pay principal
and
accrued interest in cash or, at our option, in shares of our common stock.
If
the we elect to pay principal and interest in shares of our common stock, the
value of each share of common stock will be equal to the lesser of (i) $1.25
and
(ii) ninety percent (90%) of the average of the daily volume weighted average
price for the common stock over the twenty trading day period immediately
preceding the date of payment. At the option of the holder of each A4 Additional
AIR Debenture, the principal amount outstanding under each such Debenture is
initially convertible at any time after the closing of Amendment No 4 into
shares of our common stock at a conversion price of $1.25.
Upon
the
occurrence of an “Event of Default” with respect to each A4 Additional AIR
Debenture, the full principal amount of each such Debenture, together with
interest and other amounts owing in respect thereof, may be accelerated at
the
holder’s option and payable in cash. The aggregate amount payable upon an Event
of Default will be equal to the “Mandatory Prepayment Amount,” which shall be
calculated for the A4 Additional AIR Debentures in the same manner as described
above with respect to the A2 AIR Debentures under Second
AIR Exercise Pursuant to Amendment No. 2.
The
A4
Additional AIR Warrants issued to the investors on February 28, 2006 are
initially exercisable into an aggregate of 3,200,000 shares of our common stock,
and the initial exercise price of each A4 Additional AIR Warrant is equal to
$1.25. The conversion price of the A4 Additional AIR Debentures and the exercise
price of the A4 Additional AIR Warrants are each subject to an anti-dilution
adjustment upon the issuance by us of securities at a price per share less
than
the then conversion price or exercise price, as applicable.
On
March
6, 2006, we agreed with the investors to amend the terms of A4 Additional AIR
Warrants to accelerate the exercise dates thereunder in respect of fifty percent
(50%) of the shares of our common stock issuable thereunder (an aggregate of
1,600,000 shares) to March 6, 2006. The A4 Additional AIR Warrants were
initially exercisable on August 31, 2006. The investors agreed to immediately
exercise fifty percent (50%) of the A4 Additional AIR Warrants (for aggregate
gross proceeds to the Company of $2,000,000) in exchange for (a) the
acceleration of the exercise period (insofar as it applied to fifty percent
(50%) of the stock issuable thereunder, and (b) the issuance of additional
warrants equal to 50% of the exercised A4 Additional AIR Warrants (an aggregate
of 800,000 shares). The new warrants have an exercise price of $3.00 per share
and will be exercisable for five years from September 6, 2006.
40
Assistance
Agreement with Eckert Seamans
On
March
30, 2005, we entered into an Assistance Agreement with Eckert Seamans, pursuant
to which Eckert Seamans advanced us funds in the amount of $325,179 for the
sole
purpose of making the interest payment and the monthly redemption payment due
on
March 31, 2005 and April 1, 2005, respectively, under the Debentures. Under
the
terms of the Assistance Agreement, we agreed to repay such advance without
interest in three equal installments due on October 1, 2005, November 1, 2005
and December 1, 2005. Because we did not make the first installment payment
on
October 1, 2005 as of that date, all amounts owed to Eckert Seamans became
payable on demand, and interest on such unpaid amounts began accruing at the
rate of 8% per annum. On March 28, 2006, we paid the outstanding balance
($337,937) due under the Assistance Agreement in full.
In
the
past, we have funded most of our development and other costs with equity
financing. While we have been able to raise equity capital as required,
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.
Issuance
of Other Warrants
On
April
17, 2006, our Board of Directors ratified the issuance to Zapfe Holdings Inc.
of
an aggregate of 204,465 shares of common stock and a warrant to purchase 102,232
shares of our common stock at an exercise price of $1.25 per share. We issued
the stock and warrant in consideration of an investment of CAD$300,000. The
warrant is exercisable until January 13, 2011. The holder has agreed that it
will not exercise this warrant if such exercise would cause the holder, together
with its respective affiliates, to beneficially own more than 9.99% of our
common stock then outstanding. The holder may exercise the warrant by tendering
cash or through a cashless exercise after the first year anniversary or prior
to
the first year anniversary if there is no effective registration statement
registering for resale the shares of common stock into which the warrants are
exercisable. The number of shares to be issued upon cashless exercise of the
warrants is determined as follows: the number of shares with respect to which
the warrant is being exercised multiplied by [(the average of the closing prices
for the five trading days immediately prior to (but not including) the exercise
date minus the exercise price) divided by the average of the closing prices
for
the five trading days immediately prior to (but not including) the exercise
date]. The shares of common stock and the shares of common stock issuable upon
exercise of the warrant were included on our registration statement filed on
February 1, 2006 and declared effective by the SEC on February 27, 2006.
On
April
17, 2006, our Board of Directors approved the issuance to one of our directors,
Dr. Gerald Bernstein, of a five-year warrant to purchase 50,000 shares of our
common stock pursuant to the terms of Dr. Bernstein’s employment agreement and
granted a bonus to an employee of our subsidiary Antigen Express, Inc. in the
form of a five-year warrant to purchase up to an aggregate of 20,000 shares
of
our common stock. Each such warrant has an exercise price of $2.66 per share,
which represented the average of the closing prices of our common stock for
the
five trading days ended April 17, 2006.
Pursuant
to the Securities Purchase Agreement dated as of June 1, 2006, each of
Cranshire, Iroquois, Smithfield and Rockmore purchased 853,659 restricted shares
of the our common stock and warrants to purchase 640,245 shares of common stock
at an exercise price of $2.45 per share. The purchase price for each Unit
consisting of one share and .75 warrants was $2.05. Consequently, each investor
paid an aggregate of $1,750,000.95 ($7.0 million in total). We also granted
the
investors certain participation rights pursuant to which, upon any financing
at
any time within the next twelve months, the investors will have the right to
purchase up to 100% of such financing. The exercise price of the Related
Warrants is subject to certain 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. This
transaction closed on June 2, 2006.
On
June
1, 2006, we agreed with the investors to amend the terms of outstanding warrants
to purchase an aggregate of 4,364,190 shares of common stock (the "Outstanding
Warrants") to accelerate their exercise periods to June 1, 2006. The Outstanding
Warrants included warrants to purchase an aggregate of 4,364,190 shares of
our
common stock with strike prices of $1.25 and $1.60 per share and exercise dates
of August 28, 2006 and July 23, 2006. These Outstanding Warrants included
warrants for 292,408 shares exercisable at $1.60 per share and warrants for
127,880 shares exercisable at $1.25 per share originally issued to Omicron
which
had been assigned to Rockmore. Each of the investors agreed to immediately
exercise the full amount of its Outstanding Warrants. On June 2, 2006, in
consideration of the investors' exercise of the Outstanding Warrants, we issued
to each investor additional warrants exercisable for a period of five years
entitling the holder thereof to purchase a number of shares of common stock
equal to 75% of the shares of common stock issuable upon the conversion in
full
(without regard to any restrictions on conversion therein contained) of the
Outstanding Warrants (an aggregate of 3,273,144 shares of common stock) at
an
exercise price of $2.35 per share.
41
Going
Concern Uncertainty
In
their
audit opinion issued in connection with our consolidated balance sheet as of
July 31, 2005 and our consolidated statements of operation, stockholders’ equity
and cash flows for the year then ended and for the period from November 2,
1995
(date of inception) to July 31, 2005, our auditors expressed substantial doubt
about our ability to continue as a going concern given our recurring net losses,
negative cash flows from operations and working capital deficiency.
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities
and commitments in the normal course of business. We have experienced negative
cash flows from operations since inception and had an accumulated deficit at
April 30, 2006 of approximately $175,705,417. We have funded our activities
to
date almost exclusively from debt and equity financings.
We
are in
the development stage and have realized minimal revenues to date. 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 FDA or other regulatory
approvals are obtained. Management’s plans in order to meet our operating cash
flow requirements include financing activities such as private placements of
our
common stock, preferred stock offerings, debt and convertible debt instruments.
Management is also actively pursuing industry collaboration activities,
including product licensing and specific project financing.
While
we
believe that we will be successful in obtaining the necessary financing to
fund
our operations, there are no assurances that such additional funding will be
achieved and that we will succeed in our future operations. The financial
statements do not include any adjustments relating to the recoverability and
classification of recorded asset amounts or amounts of liabilities that might
be
necessary should we be unable to continue in existence.
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:
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.
42
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
the
Company does not have any non-consolidated special purpose
entities.
Contractual
Obligations
Payments
Due by Period
|
|||||
Contractual
Obligations
|
Total
|
Less
than 1
year
|
1-3
years
|
3-5
years
|
More
than
5
years
|
Long-Term
Debt Obligations
|
4,729,336
|
3,307,455
|
1,421,881
|
0
|
0
|
Capital
Lease Obligations
|
0
|
0
|
0
|
0
|
0
|
Operating
Lease Obligations
|
52,362
|
32,092
|
16,903
|
3,367
|
0
|
Purchase
Obligations
|
0
|
0
|
0
|
0
|
0
|
Other
Long-Term Liabilities Reflected on the
Registrant's
Balance Sheet under GAAP
|
0
|
0
|
0
|
0
|
0
|
Total
|
$4,781,698
|
$3,339,547
|
$1,438,784
|
$3,367
|
$0
|
Related
Party Transactions
Prior
to
January 1, 1999, a portion of our general and administrative expenses resulted
from transactions with affiliated persons, and a number of capital transactions
also involved affiliated persons. Although these transactions were not the
result of "arms-length" negotiations, we do not believe that this fact had
a
material impact on our results of operations or financial position. Prior to
December 31, 1998, we classified certain payments to executive officers for
compensation and expense reimbursements as "Research and Development - related
party" and "General and Administrative - related party" because the executive
officers received such payments through personal services corporations rather
than directly. After December 31, 1998, these payments have been and will
continue to be accounted for as though the payments were made directly to the
officers, and not as a related party transaction. With the exception of our
arrangement with our management company described below, we do not foresee
a
need for, and therefore do not anticipate, any related party transactions in
the
current fiscal year.
We
utilize a management company to manage all of our real properties. The property
management company is owned by Anna Gluskin, our Chairman, Chief Executive
Officer and President, Rose Perri, our Chief Operating Officer, Chief Financial
Officer, Treasurer and Secretary, and the estate of Mark Perri, our former
Chairman of the Board. In the fiscal quarters ended April 30, 2006 and 2005,
we
paid the management company approximately $11,864 and $11,000, respectively,
in
management fees.
At
April
30, 2006, EBI, Inc., a company controlled by Ms. Rose Perri, was indebted to
the
Company in the amount of $415,828 for obligations incurred in 1997 and 1998.
The
U.S. dollar amount of this obligation has been shown on our balance sheets
as
“Due From Related Party” and the circumstances of the incurrence of this
obligation have been reported in our forms 10-K/A and Proxy Statements including
those for fiscal year 2005 and our most recent annual meeting of stockholders.
On April 30, 2006, the Company, Ms. Perri and EBI agreed to satisfy the amounts
due from EBI by an offsetting reduction in the amount of compensation owed
by
the Company to Ms. Perri.
43
New
Accounting Pronouncements
In
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
123(R), "Share-Based Payment" ("SFAS 123(R)"), which requires all companies
to
measure compensation cost for all share-based payments (including employee
stock
options) at fair value and to recognize cost over the vesting period. In March
2005, the SEC released SEC Staff Accounting Bulletin No. 107, "Share-Based
Payment" ("SAB 107"). SAB 107 provides the SEC staff position regarding the
application of SFAS 123(R), including interpretive guidance related to the
interaction between SFAS 123(R) and certain SEC rules and regulations, and
provides the staff's views regarding the valuation of share-based payment
arrangements for public companies. SAB 107 highlights the importance of
disclosures made related to the accounting for share-based payment transactions.
In April 2005, the SEC announced that companies may implement SFAS 123(R) at
the
beginning of their next fiscal year beginning after June 15, 2005, or December
15, 2005 for small business issuers. The Company implemented the provisions
of
SFAS 123(R) and SAB 107 in the first quarter of fiscal 2006 using the
modified-prospective method, and it did not have a material impact on our
financial position or cash flows. See Note 3 - "Stock Based Compensation" for
further information and the required disclosures under SFAS 123(R) and SAB
107,
including the impact of the implementation on our results of
operations.
In
December 2004, the FASB issued SFAS No. 153, "Exchanges of Nonmonetary Assets
-
an amendment of APB Opinion No. 29." The statement addresses the measurement
of
exchanges of nonmonetary assets and eliminates the exception from fair value
measurement for nonmonetary exchanges of similar productive assets and replaces
it with an exception for exchanges that do not have commercial substance. SFAS
No. 153 is effective for nonmonetary asset exchanges occurring in fiscal periods
beginning after June 15, 2005. This adoption of this statement did not have
a
significant impact on our consolidated results of operations or our financial
position.
In
May
2005, the FASB issued SFAS No. 154, “Accounting Changes and Error Corrections.”
This statement replaces APB No. 20 and SFAS No. 3 and changes the requirements
for the accounting for and reporting of a change in accounting principle. APB
No. 20 previously required that most voluntary changes in accounting principle
be recognized by including in net income of the period of the change the
cumulative effect of changing to the accounting principle. SFAS No. 154 requires
retrospective application to prior periods’ financial statements of voluntary
changes in accounting principle. SFAS No. 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December
15, 2005. We are currently evaluating the impact of adopting this
statement.
In
February 2006, the FASB issued SFAS No. 155,”Accounting for Certain Hybrid
Financial Instruments - an amendment of FASB Statements No. 133 and 140,” to
simplify and make more consistent the accounting for certain financial
instruments. Specifically, SFAS No. 155 amends SFAS No. 133, Accounting for
Derivative Instruments and Hedging Activities, to permit fair value
remeasurement for any hybrid financial instrument with an embedded derivative
that otherwise would require bifurcation, provided that the whole instrument
is
accounted for on a fair value basis. SFAS No. 155 amends SFAS No. 140,
Accounting for the Impairment or Disposal of Long-Lived Assets, to allow a
qualifying special-purpose entity (SPE) to hold a derivative financial
instrument that pertains to a beneficial interest other than another derivative
financial instrument. SFAS No. 155 applies to all financial instruments acquired
or issued after the beginning of an entity’s first fiscal year that begins after
September 15, 2006, with earlier application allowed. The
Company does not expect that the adoption of SFAS No. 155 will have a
significant impact on the consolidated results of operations or financial
position of the Company.
In
March
2006, the FASB issued SFAS No. 156, “Accounting for Servicing of Financial
Assets”, to simplify accounting for separately recognized servicing assets and
servicing liabilities. SFAS No. 156 amends SFAS No. 140, “Accounting for
Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.
Additionally, SFAS No. 156 permits, but does not require, an entity to choose
either the amortization method or the fair value measurement method for
measuring each class of separately recognized servicing assets and servicing
liabilities. SFAS No. 156 applies to all separately recognized servicing assets
and servicing liabilities acquired of issued after the beginning of an entity’s
fiscal year that begins after September 15, 2006, although early adoption is
permitted. The Company believes that this SFAS will have no effect on the
Company’s financial condition or results of operations.
44
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
We
are
exposed to market risks associated with changes in the exchange rates between
U.S. and Canadian currencies and with changes in the interest rates related
to
our fixed rate debt. We do not believe that any of these risks will have a
material impact on our financial condition, results of operations and cash
flows.
At
the
present time, we maintain our cash in short-term government or government
guaranteed instruments, short-term commercial paper, interest bearing bank
deposits or demand bank deposits which do not earn interest. A substantial
majority of these instruments and deposits are denominated in U.S. dollars,
with
the exception of funds denominated in Canadian dollars on deposit in Canadian
banks to meet short-term operating needs in Canada. At the present time, with
the exception of professional fees and costs associated with the conduct of
clinical trials in the United States and Europe, substantially all of our
operating expense obligations are denominated in Canadian dollars. We do not
presently employ any hedging or similar strategy intended to mitigate against
losses that could be incurred as a result of fluctuations in the exchange rates
between U.S. and Canadian currencies.
As
of
April 30, 2006, we have fixed rate debt totaling $3,356,260. This amount
consists of the following:
Loan
Amount |
Interest
Rate
per Annum |
|
$436,529
|
4.913%
|
|
$270,657
|
4.924%
|
|
$1,161,754
|
6.07%
|
|
$658,557
|
6.85%
|
|
$358,240
|
8.5%
|
|
$210,799
|
10%
|
|
$259,724
|
16.5%
|
|
$3,356,260
|
Total
|
These
debt instruments mature from June 2006 through March 2009. \As our fixed rate
debt instruments mature, we will likely refinance such debt at the existing
market interest rates which may be more or less than interest rates on the
maturing debt. Since this debt is fixed rate debt, if interest rates were to
increase 100 basis points prior to maturity, there would be no impact on
earnings or cash flows.
We
have
neither issued nor own any long-term debt instruments, or any other financial
instruments, for trading purposes and as to which we would be subject to
material market risks.
Item
4. Controls and Procedures.
Evaluation
of disclosure controls and procedures
Based
on
our management's evaluation (with the participation of our principal executive
officer and principal financial officer), as of the end of the period covered
by
this Quarterly Report on Form 10-Q, our chief executive officer and chief
financial officer have concluded that our disclosure controls and procedures
(as
defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities
Exchange Act of 1934, as amended (the "Exchange Act")) are effective to ensure
that information required to be disclosed by us in the reports that we file
or
submit under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and forms.
45
Changes
in internal control over financial reporting
There
was
no change in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15(d)-15(f) under the Exchange Act) during the period covered
by
this Quarterly Report on Form 10-Q that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
None.
Item
1A. Risk Factors.
In
addition to the other information included in this Quarterly Report on Form
10-Q, you should carefully review and consider the factors discussed in
Part
I, Item 1. Business - Certain Additional Risk Factors
of our
Annual Report on Form 10-K for the year ended July 31, 2005, certain of which
have been updated below. These factors materially affect our business, financial
condition or future results of operations. The risks, uncertainties and other
factors described in our Annual Report on Form 10-K and below are not the only
ones facing our company. Additional risks, uncertainties and other factors
not
presently known to us or that we currently deem immaterial may also impair
our
business operations, financial condition or operating results. Any of the risks,
uncertainties and other factors could cause the trading price of our common
stock to decline substantially.
Risks
Related to Our Financial Condition
We
have a history of losses and will incur additional
losses.
We
are a
development stage company with a limited history of operations, and do not
expect sufficient revenues to support our operation in the immediately
foreseeable future. We do expect to receive some revenue from the sale of our
oral insulin product in Ecuador in fiscal 2006. To date, we have not been
profitable and our accumulated net loss was $175,705,417 at April 30, 2006.
Our
losses have resulted principally from costs incurred in research and
development, including clinical trials, and from general and administrative
costs associated with our operations. While we seek to attain profitability,
we
cannot be sure that we will ever achieve product and other revenue sufficient
for us to attain this objective.
With
the
exception of our oral insulin formulation which was approved for commercial
sale
in Ecuador in early May 2005, our product candidates are in research or early
stages of pre-clinical and clinical development. We will need to conduct
substantial additional research, development and clinical trials. We will also
need to receive necessary regulatory clearances both in the United States and
foreign countries and obtain meaningful patent protection for and establish
freedom to commercialize each of our product candidates. We cannot be sure
that
we will obtain required regulatory approvals, or successfully research, develop,
commercialize, manufacture and market any other product candidates. We expect
that these activities, together with future general and administrative
activities, will result in significant expenses for the foreseeable future.
We
need additional capital.
To
progress in product development, production, marketing, and distribution 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:
46
|
Ÿ
|
to
proceed with the development of our buccal insulin product;
|
|
Ÿ
|
to
develop other buccal and immunomedicine products;
|
|
Ÿ
|
to
develop new products based on our buccal delivery and immunomedicine
technologies, including clinical testing relating to new products;
|
|
Ÿ
|
to
develop or acquire other technologies or other lines of business;
|
|
Ÿ
|
to
establish and expand our manufacturing capabilities;
|
|
Ÿ
|
to
finance general and administrative and research activities that are
not
related to specific products under development;
|
|
Ÿ
|
to
finance the research and development activities of our subsidiary
Antigen;
and
|
|
Ÿ
|
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. Recent changes in the application of the rules
of The NASDAQ Stock Market may also make it more difficult for us to raise
private equity capital.
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.
Our
independent auditors have expressed substantial doubt about our ability to
continue as a going concern.
In
their
audit opinion issued in connection with our consolidated balance sheet as of
July 31, 2005 and our consolidated statements of operations, stockholders’
equity and cash flows for the year then ended and for the period from November
2, 1995 (date of inception) to July 31, 2005, our auditors have expressed a
substantial doubt about our ability to continue as a going concern given our
recurring net losses, negative cash flows from operations and working capital
deficiency.
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities
and commitments in the normal course of business. The financial statements
do
not include any adjustments relating to the recoverability and classification
of
recorded asset amounts or amounts of liabilities that might be necessary should
we be unable to continue in existence.
Risks
Related to Our Technologies
With
the exceptions of Generex Oral-lyn™ and Glucose RapidSpray™, our technologies
and products are at an early stage of development and we cannot expect revenues
in respect thereof in the foreseeable future.
47
With
the
exception of Generex Oral-lyn™, our proprietary oral insulin spray formulation
which has been approved for commercial marketing and sale in Ecuador for the
treatment of Type-1 and Type-2 diabetes, and Glucose RapidSpray™, an
over-the-counter confectionary, we have no products approved for commercial
sale
at the present time. 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.
While
over 1,100 patients with diabetes have been dosed with our oral insulin
formulation at approved facilities in seven countries, our insulin product
has
only recently been approved for marketing in Ecuador. Until we can manufacture,
market and distribute our oral insulin product in Ecuador and can establish
that
it is a commercially viable product, we will not receive revenues from ongoing
operations.
Until
we receive regulatory approval to sell our products in one or more countries
other than Ecuador, 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.
Only
one
of our products has been approved for commercial sale by drug regulatory
authorities, and that approval was obtained in Ecuador. We have begun the
regulatory approval process for our oral insulin formulation, buccal morphine
product in other countries. Our immunomedicine products are in the pre-clinical
stage of development, with the exception of our Phase 1 trial in human patients
with stage II HER-2/neu positive breast cancer.
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 never receive approval
for
one or more product candidates 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 Quarterly Report
on Form 10-Q 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 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.
Risks
Related to Marketing of Our Potential Products
We
may not become, or stay, profitable even if our products are approved for
sale.
Even
if
we obtain regulatory approval to market our oral insulin product or any other
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:
|
Ÿ
|
acceptance
of the formulation or treatment by health care professionals and
diabetic
patients;
|
|
Ÿ
|
the
availability, effectiveness and relative cost of alternative diabetes
or
immunomedicine treatments that may be developed by competitors; and
|
|
Ÿ
|
the
availability of third-party (i.e., insurer and governmental agency)
reimbursements.
|
48
We
will
not receive revenues from our oral insulin formulation in Ecuador or any of
our
other products that may receive regulatory approval until we can successfully
manufacture, market and distribute them in the relevant market.
We
will
have to depend upon others for marketing and distribution of our products,
including Generex Oral-lyn™ in Ecuador, 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. Accordingly, our
competitors may succeed in developing competing technologies, obtaining FDA
approval for products or gaining market acceptance more rapidly than we can.
In
January, 2006, the FDA approved Pfizer, Inc.’s inhalable form of insulin, the
first non-injected insulin to be approved by the FDA. Pfizer’s product in
inhaled through the mouth and absorbed in the lungs. While we believe that
absorption though the buccal cavity offers several advantages over absorption
through the lungs, Pfizer’s early approval could allow it to capture a large
portion of the market.
Risks
Related to the Market for Our Common Stock
Our
common stock could be delisted from The NASDAQ Capital
Market.
On
June
5, 2003, our common stock was delisted from The NASDAQ National Market because
of our failure to maintain a minimum of $10,000,000 in stockholders' equity.
On
June 5, 2003, our stock began trading on The NASDAQ Capital Market. The NASDAQ
Capital Market has its own standards for continued listing, including a minimum
of $2.5 million stockholders' equity. As of July 31, 2004, our stockholders'
equity was $529,751. As a result, on November 19, 2004, we received notice
from
The NASDAQ Stock Market informing us that we do not comply with Marketplace
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.
On December 22, 2004, all outstanding shares of our Series A Convertible
Preferred Stock were converted to common stock, resulting in the elimination
of
approximately $14,300,000 of mezzanine equity and an equal amount was added
to
additional paid-in capital attributable to the common stock, increasing
stockholders' equity by that amount. Based on this, the delisting proceeding
relating to failure to meet stockholders’ equity standards was terminated.
Because we are still in the development stage, 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.
49
In
addition, for continued listing on both The NASDAQ National Market and Capital
Market, our stock price must be at least $1.00. From October of 2004 until
October 2005, our stock price traded below this minimum per share requirement
for thirty (30) or more consecutive business days. As a result, on November
24,
2004, we received notice from The NASDAQ Stock Market informing us that we
did
not comply with Market Rule 4310(c)(4), which requires us to have a minimum
bid
price per share of at least $1.00 for thirty (30) consecutive business days.
We
had 180 calendar days, or until May 23, 2005, subject to extension by The NASDAQ
Stock Market under certain circumstances, to regain compliance with the
Rule.
On
May
25, 2005, we received notice from the Staff of The NASDAQ Stock Market informing
us that, during the 180 calendar day period ending May 23, 2005, we had not
regained compliance with Marketplace Rule 4310(c)(4); however, the Staff noted
that on May 23, 2005, we met all initial inclusion criteria for the Capital
Market set forth in Marketplace Rule 4310(c), except for bid price. Therefore,
in accordance with Marketplace Rule 4310(c)(8)(D), we had an additional 180
calendar days to regain compliance with Rule 4310(c)(4).
On
November 14, 2005, we received written confirmation from The NASDAQ Stock Market
that we achieved compliance with the continued listing requirements in
accordance with the minimum bid price requirement under NASDAQ Marketplace
Rule
4310(c)(4).
Although
we have regained compliance with the minimum bid price requirement, 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 business days, we would likely receive a
notice from The NASDAQ Stock Market informing us of our noncompliance with
Market 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 Marketplace 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
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 Marketplace 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:
|
Ÿ
|
announcements
of research activities and technology innovations or new products
by us or
our competitors;
|
50
|
Ÿ
|
changes
in market valuation of companies in our industry generally;
|
|
Ÿ
|
variations
in operating results;
|
|
Ÿ
|
changes
in governmental regulations;
|
|
Ÿ
|
developments
in patent and other proprietary rights;
|
|
Ÿ
|
public
concern as to the safety of drugs or treatments developed by us or
others;
|
|
Ÿ
|
results
of clinical trials of our products or our competitors' products;
and
|
|
Ÿ
|
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.
Item.
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
Unregistered
Sales of Equity Securities
In
the
fiscal quarter ended April 30, 2006, we sold warrants to purchase shares of
our
common stock in the amounts and to the purchasers and on the terms as disclosed
above in this Quarterly Report under the captions Amendments
of Outstanding Warrants and
Exercise
of A4 Additional AIRs under
Part
I - Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations- Financial Condition, Liquidity and Resources,
which
disclosures are incorporated herein by reference. We undertook the offer and
sale of these warrants, including shares of common stock into which such
warrants are exercisable, by us to the purchasers in reliance upon the exemption
from registration under Section 4(2) of the Securities Act of 1933, as amended
(the “Securities Act”). Each of the purchasers has previously represented and
warranted to us that it is an “accredited investor” as that term is defined in
Rule 501(a) of Regulation D promulgated under the Securities Act. Any
certificates issued representing such warrants and shares of common stock issued
upon exercise thereof will be legended to indicate that they are restricted.
No
sale of these securities involved the use of underwriters.
On
April
17, 2006, we issued 204,465 shares of common stock and a warrant to purchase
102,232 shares of our common stock to Zapfe Holdings Inc. We issued the stock
and warrant in consideration of an investment of CAD$300,000. The exercise
price
of the warrant is $1.25 per share. The conversion features of the warrant are
described in this Quarterly Report on Form 10-Q above under the caption
Financial
Condition, Liquidity and Resources
of
Part
I - Item 2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations.
The
sale of the shares of common stock and warrant, including the shares of common
stock to be issued upon exercise of the warrant, is exempt from the registration
under Securities Act in reliance upon Section 4(2) thereof. Zapfe Holdings
Inc.
has represented to us that it is an “accredited investor” as that term is
defined in Rule 501(a) of Regulation D. The shares of common stock and the
shares of common stock issuable upon exercise of the warrant were included
on
our registration statement filed on February 1, 2006 and declared effective
by
the SEC on February 27, 2006. The sale did not involve the use of underwriters,
and no commissions were paid in connection with the sale, if any,
thereof.
51
On
April
17, 2006, we issued an aggregate of 72,000 shares of our restricted common
stock
to The Abajian Group, LLC (“Abajian”) as partial consideration for Abajian’s
provision of services under an agreement with us relating to the solicitation,
evaluation and design of third-party wholesale and retail distribution channels
for certain of our products. All shares of our common stock issued to Abajian
shall be restricted for 18 months from the date of issuance. Abajian has certain
“piggyback” registration rights with respect to the shares of common stock. The
sales of all such shares of restricted common stock were exempt from
registration under the Securities Act, in reliance upon Section 4(2) thereof.
Abajian has represented us that it is an “accredited investor” as that term is
defined in Rule 501(a) of Regulation D. The certificate issued for the
restricted shares of common stock was legended to indicate that the shares
are
restricted. The sale of such shares did not involve the use of underwriters,
and
no commissions were paid in connection with the issuance or sale, if any,
thereof.
On
April
17, 2006, we issued 1,400 shares of our restricted common stock to a consultant
pursuant to early termination of the consulting agreement between the consultant
and us. All shares of our common stock issued to the consultant shall be
restricted for 12 months from the date of issuance. The sales of all such shares
of restricted common stock were exempt from registration under the Securities
Act, in reliance upon Section 4(2) thereof. The consultant is a resident of
Canada. The certificate issued for the restricted shares of common stock was
legended to indicate that the shares are restricted. The sale of such shares
did
not involve the use of underwriters, and no commissions were paid in connection
with the issuance or sale, if any, thereof.
On
April
17, 2006, we issued a five-year warrant to purchase 50,000 shares of our common
stock to one of our directors, Dr. Gerald Bernstein. The warrant was issued
pursuant to the terms of Dr. Bernstein’s employment agreement. The warrant has
an exercise price of $2.66 per share, which represented the average of the
closing prices of our common stock for the five trading days ended April 17,
2006. In the event that the issuance of this warrant is deemed to be a “sale” as
that term is defined under Section 2(a)(3) of the Securities Act, such “sale” is
exempt from registration under the Securities Act in reliance upon Section
4(2)
thereof. Dr. Bernstein, as a director of Generex, is an “accredited investor” as
that term is defined in Rule 501(a) of Regulation D. The warrant was, and the
certificates representing the shares of common stock issuable upon exercise
thereof will be, legended to indicate that they are restricted. The sale, if
any, of such warrant did not involve the use of underwriters, and no commissions
were paid in connection with the issuance or sale, if any, thereof.
In
addition, on April 17, 2006, our Board of Directors granted a bonus to an
employee of our subsidiary Antigen Express, Inc. of a five-year warrant to
purchase up to an aggregate of 20,000 shares of our common stock at an exercise
price of $2.66 per share, which represented the average of the closing prices
of
our common stock for the five trading days ended April 17, 2006. The issuance
of
this warrant is not deemed to be a “sale” as that term is defined under Section
2(a)(3) of the Securities Act. The warrant was, and the certificates
representing the shares of common stock issuable upon exercise of the warrant
will be, legended to indicate that they are restricted.
On
April
17, 2006, the Board of Directors also approved the donation of 25,000 shares
of
our common stock to the University Campus Bio-Medico in Rome, Italy. The
issuance of these shares is not deemed to be a “sale” as that term is defined
under Section 2(a)(3) of the Securities Act. The shares of common stock were
included on our registration statement filed on February 1, 2006 and declared
effective by the SEC on February 27, 2006.
On
June
1, 2006, we entered into a Securities Purchase Agreement with four accredited
investors for the sale of shares of its common stock and warrants in a private
placement for an aggregate purchase price of $7.0 million. This transaction
closed on June 2, 2006. Pursuant to the Securities Purchase Agreement, each
of
Cranshire, Rockmore, Iroquois and Smithfield purchased 853,659 restricted shares
of the our common stock (the "Shares") and warrants to purchase 640,245 shares
of common stock at an exercise price of $2.45 per share (the "Related
Warrants"). The purchase price for each Unit consisting of one share and .75
warrants was $2.05. Consequently, each investor paid an aggregate of
$1,750,000.95. The terms and conditions applicable to the Shares and Related
Warrants, including the conversion features of the Related Warrants, are
described in this Quarterly Report on Form 10-Q above under the caption
Financial
Condition, Liquidity and Resources
of
Part
I - Item 2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations.
On
June
1, 2006, we agreed with the investors to amend the terms of outstanding warrants
to purchase an aggregate of 4,364,190 shares of common stock (the "Outstanding
Warrants") to accelerate their exercise periods to June 1, 2006. The Outstanding
Warrants included warrants to purchase an aggregate of 4,364,190 shares of
our
common stock with strike prices of $1.25 and $1.60 per share and exercise dates
of August 28, 2006 and July 23, 2006. These Outstanding Warrants included
warrants for 292,408 shares exercisable at $1.60 per share and warrants for
127,880 shares exercisable at $1.25 per share originally issued to Omicron
which
had been assigned to Rockmore. Each of the investors agreed to immediately
exercise the full amount of its Outstanding Warrants. On June 2, 2006, in
consideration of the investors' exercise of the Outstanding Warrants, we issued
to each investor additional warrants exercisable for a period of five years
entitling the holder thereof to purchase a number of shares of common stock
equal to 75% of the shares of common stock issuable upon the conversion in
full
(without regard to any restrictions on conversion therein contained) of the
Outstanding Warrants (an aggregate of 3,273,144 shares of Common Stock) at
an
exercise price of $2.35 per share. We undertook the offer and sale of the Shares
and Related Warrants, as well as the shares of common stock issuable upon
exercise of the Related Warrants and the Outstanding Warrants, in reliance
upon
Rule 506 of Regulation D and Section 18(b)(4)(D) of the Securities Act. No
underwriting commissions, placement fees or similar amounts were paid in
connection with the issuance of the Shares and Related Warrants or the exercise
of the Outstanding Warrants.
52
Issuer
Purchases of Equity Securities
Neither
we nor any affiliated purchaser (as defined in Section 240.10 b-18(a)(3) of
the
Exchange Act) purchased any of our equity securities during the fiscal quarter
ended April 30, 2006.
Item
3. Defaults Upon Senior Securities.
Under
the
terms of an Assistance Agreement with Eckert Seamans Cherin & Mellott, LLC,
, we agreed to repay an advance of $325,179 without interest in three equal
installments due on October 1, 2005, November 1, 2005 and December 1, 2005.
Because we did not make the first installment payment on October 1, 2005, all
amounts owed to Eckert Seamans became payable on demand as of that date, and
interest on such unpaid amounts began accruing at the rate of 8% per annum.
On
March 28, 2006, we paid the outstanding balance ($337,937) due under the
Assistance Agreement in full. The terms and conditions of the Assistance
Agreement with Eckert Seamans, are described in this Quarterly Report on Form
10-Q above under the caption Financial
Condition, Liquidity and Resources
of
Part
I - Item 2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations.
Item
4. Submission of Matters to a Vote of Security Holders.
None.
Item
5. Other Information.
The
disclosures set forth under Part
II - Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
and
Part
II - Item 3. Defaults Upon Senior Securities
are
incorporated herein by reference.
53
Item
6. Exhibits.
Exhibit
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|
|
|||
Number
|
Description
of Exhibit
|
||||
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
|
|||
|
|
|
|||
3(II)
|
|
Bylaws
of Generex Biotechnology Corporation (incorporated by reference to
Exhibit
3.2 to Generex Biotechnology Corporation’s Registration Statement on Form
S-1 (File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|
|||
4.1
|
|
Form
of common stock certificate (incorporated by reference to Exhibit
4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|
|||
4.2
|
|
Warrant
issued to Elliott International, L.P. and Elliott Associates, L.P.,
dated
July 5, 2001 (incorporated by reference to Exhibit 9 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on July 17,
2001)
|
|||
|
|
|
|||
4.3.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|
|||
4.3.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|
|||
4.3.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.4 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.5 to Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P. dated June 6, 2003
(incorporated by reference to Exhibit 4.6 to Generex Biotechnology
Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003
filed on August 13, 2003)
|
54
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.4.4
|
|
Form
of replacement Warrant issued to warrant holders exercising at reduced
exercise price in May and June 2003 (incorporated by reference to
Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|||
|
|
|
|||
4.5.1
|
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.2
|
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.3
|
|
Form
of Warrant issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.5.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|||
4.6.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|
|||
4.8.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
55
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.8.3
|
|
Warrant
issued in connection with Exhibit 4.8.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|
|||
4.9.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.9.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.9.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.3
|
|
Warrant
issued in connection with Exhibit 4.10.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.11.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|
|||
4.11.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|||
|
|
|
|||
4.11.3
|
|
Form
of Warrant issued in connection with Exhibit 4.11.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|
|||
4.11.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.11.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
56
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.12.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|
|||
4.12.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.12.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.12.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|
|||
4.12.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.12.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.12.5
|
|
Custodial
and Security Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation, Feldman Weinstein LLP, as custodian, and
the
investors named therein (incorporated by reference to Exhibit 4.6
to
Generex Biotechnology Corporation’s Report on Form 8-K filed on November
12, 2004)
|
|||
|
|
|
|||
4.12.6
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.13
|
|
Termination
Agreement, dated December 17, 2004, by and among Generex Biotechnology
Corporation and Elan Corporation plc and Elan International Services,
Ltd.
(incorporated by reference to Exhibit 4.19 to Generex Biotechnology
Corporation’s Quarterly Report on Form 10-Q filed on June 14,
2005)
|
|||
|
|
|
|||
4.14
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|||
|
|
|
|||
4.15.1
|
|
Amendment
No. 1 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on June 17, 2005)
|
|||
|
|
|
|||
4.15.2
|
|
Form
of AIR Debenture issued in connection with Exhibit 4.15.1 (incorporated
by
reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.15.3
|
|
Form
of AIR Warrant issued in connection with Exhibit 4.15.1(incorporated
by
reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.15.4
|
|
Form
of Additional AIR issued in connection with Exhibit 4.15.1 (incorporated
by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s
Report on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.16.1
|
|
Amendment
No. 2 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9,
2005)
|
57
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.16.2
|
|
Form
of Air Debenture issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.16.3
|
|
Form
of AIR Warrant issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.16.4
|
|
Form
of Additional AIR issued in connection with Exhibit 4.16.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.17
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on October
27, 2005
(incorporated by reference to Exhibit 4.31 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 31,
2005)
|
|||
|
|
|
|||
4.18.1
|
|
Amendment
to the Additional Investment Right issued by Generex Biotechnology
Corporation to Omicron Master Trust on June 17, 2005 (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.18.2
|
|
Additional
AIR Debenture issued by Generex Biotechnology Corporation to Omicron
Master Trust on October 27, 2005 issued in connection with Exhibit
4.18.1
(incorporated by reference to Exhibit 4.37 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|
|||
4.18.3
|
|
Additional
AIR Warrant issued by Generex Biotechnology Corporation to Omicron
Master
Trust on October 27, 2005 issued in connection with Exhibit 4.18.1
(incorporated by reference to Exhibit 4.38 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|
|||
4.19.1
|
|
Amendment
No. 3 to Securities Purchase Agreement and Registration Rights Agreement
entered into by and among Generex Biotechnology Corporation and the
Purchasers listed on the signature pages thereto (incorporated by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.2
|
|
Form
of AIR Debentures issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.3
|
|
Form
of AIR Warrants issued in connection with Exhibit 4.19.1 (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.4
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.20
|
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on June 17, 2005 in connection with the
First
AIR Exercise (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|
|||
4.21
|
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on September 8, 2005 in connection with
the
Second AIR Exercise (incorporated by reference to Exhibit 4.3 to
Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|
|||
4.22
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
58
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.23
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
|
|
|
|||
4.24
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Omicron
Master Trust dated February 27, 2006 (incorporated by reference to
Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.25
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference to
Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.26
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|||
4.27
|
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).
|
||||
4.28
|
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).
|
||||
4.29
|
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).
|
||||
4.30
|
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).
|
||||
4.31
|
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).
|
||||
4.32
|
|
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)
|
|||
4.33
|
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc.
|
|||
4.34
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April 17,
2006
to certain employees.
|
|||
4.35
|
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)
|
59
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.36
|
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)
|
||||
4.37
|
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)
|
||||
4.38
|
Form
of Warrant issued by Generex Biotechnology Corporation on June 1,
2006 in
connection with Exhibit 4.37 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
||||
9
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|||
|
|
|
|||
31.2
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|||
|
|
|
|||
32
|
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002
|
(1) In
the case of incorporation by reference to documents filed by the
Registrant under the Exchange Act, the Registrant’s file number under the
Exchange Act is 000-25169.
|
60
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
|
|
|
GENEREX
BIOTECHNOLOGY CORPORATION
(Registrant)
|
|
|
|
|
Date:
June 14, 2006
|
By:
|
/s/ Anna
E.
Gluskin
|
|
Anna
E. Gluskin
Chairman,
President and Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
|
Date:
June 14, 2006
|
By:
|
/s/ Rose
C.
Perri
|
|
Rose
C. Perri
Chief
Operating Officer, Chief Financial Officer, Treasurer and
Secretary
|
61
Generex
Biotechnology Corporation
Form
10-Q
April
30,
2006
Exhibit
Index
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
||||
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
|
|||
|
|
|
|||
3(II)
|
|
Bylaws
of Generex Biotechnology Corporation (incorporated by reference
to Exhibit
3.2 to Generex Biotechnology Corporation’s Registration Statement on Form
S-1 (File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|
|||
4.1
|
|
Form
of common stock certificate (incorporated by reference to Exhibit
4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
|
|||
|
|
|
|||
4.2
|
|
Warrant
issued to Elliott International, L.P. and Elliott Associates, L.P.,
dated
July 5, 2001 (incorporated by reference to Exhibit 9 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on July 17,
2001)
|
|||
|
|
|
|||
4.3.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore
Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard
Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|
|||
4.3.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore
Capital,
Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard
Todd
Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 10-Q/A for the quarter ended April 30, 2003 filed on August
13,
2003)
|
|||
|
|
|
|||
4.3.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners,
L.P.;
Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial;
Omicron
Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures,
LLC
dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to
Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.1
|
|
Form
of Securities Purchase Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.4 to
Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.2
|
|
Form
of Registration Rights Agreement entered into with Cranshire Capital,
L.P.
dated June 6, 2003 (incorporated by reference to Exhibit 4.5 to
Generex
Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended
April 30, 2003 filed on August 13, 2003)
|
|||
|
|
|
|||
4.4.3
|
|
Form
of Warrant granted to Cranshire Capital, L.P. dated June 6, 2003
(incorporated by reference to Exhibit 4.6 to Generex Biotechnology
Corporation’s Report on Form 10-Q/A for the quarter ended April 30, 2003
filed on August 13, 2003)
|
62
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.4.4
|
|
Form
of replacement Warrant issued to warrant holders exercising at
reduced
exercise price in May and June 2003 (incorporated by reference
to Exhibit
4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the
period ended July 31, 2003 filed on October 29, 2003)
|
|||
|
|
|
|||
4.5.1
|
|
Securities
Purchase Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.2
|
|
Registration
Rights Agreement, dated December 19, 2003, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.3
|
|
Form
of Warrant issued in connection with Exhibit 4.5.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K/A filed on March 24, 2004)
|
|||
|
|
|
|||
4.5.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.5.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K/A filed on March 24,
2004)
|
|||
4.6.1
|
|
Securities
Purchase Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.2
|
|
Registration
Rights Agreement, dated January 7, 2004, by and between Generex
Biotechnology Corporation and ICN Capital Limited (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.3
|
|
Warrant
issued in connection with Exhibit 4.6.1 (incorporated by reference
to
Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.6.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.6.1 (incorporated
by
reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.1
|
|
Securities
Purchase Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.2
|
|
Registration
Rights Agreement, dated January 9, 2004, by and between Generex
Biotechnology Corporation and Vertical Ventures, LLC (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.3
|
|
Warrant
issued in connection with Exhibit 4.7.1 (incorporated by reference
to
Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.7.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.7.1 (incorporated
by
reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.1
|
|
Securities
Purchase Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.9 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|
|||
4.8.2
|
|
Registration
Rights Agreement, dated February 6, 2004, by and between Generex
Biotechnology Corporation and Alexandra Global Master Fund, Ltd.
(incorporated by reference to Exhibit 4.10 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on March 1,
2004)
|
63
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.8.3
|
|
Warrant
issued in connection with Exhibit 4.8.1 (incorporated by reference
to
Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.8.1 (incorporated
by
reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.8.5
|
|
Escrow
Agreement, dated February 26, 2004, by and among Generex Biotechnology
Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global
Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to
Generex
Biotechnology Corporation’s Report on Form 8-K filed on March 1,
2004)
|
|||
|
|
|
|||
4.9.1
|
|
Securities
Purchase Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by
reference
to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.9.2
|
|
Registration
Rights Agreement, dated February 11, 2004, by and between Generex
Biotechnology Corporation and Michael Sourlis (incorporated by
reference
to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.9.3
|
|
Additional
Investment Right issued in connection with Exhibit 4.9.1 (incorporated
by
reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.1
|
|
Securities
Purchase Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.2
|
|
Registration
Rights Agreement, dated February 13, 2004, by and between Generex
Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated
by
reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.3
|
|
Warrant
issued in connection with Exhibit 4.10.1 (incorporated by reference
to
Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on March 1, 2004)
|
|||
|
|
|
|||
4.10.4
|
|
Additional
Investment Right issued in connection with Exhibit 4.10.1 (incorporated
by
reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on
Form 8-K filed on March 1, 2004)
|
|||
|
|
|
|||
4.11.1
|
|
Securities
Purchase Agreement, dated June 23, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|
|||
4.11.2
|
|
Registration
Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology
Corporation and the investors (incorporated by reference to Exhibit
4.2 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14,
2004)
|
|||
|
|
|
|||
4.11.3
|
|
Form
of Warrant issued in connection with Exhibit 4.11.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on July 14, 2004)
|
|||
|
|
|
|||
4.11.4
|
|
Form
of Additional Investment Right issued in connection Exhibit 4.11.1
(incorporated by reference to Exhibit 4.4 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on July 14,
2004)
|
64
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.12.1
|
|
Securities
Purchase Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|
|||
4.12.2
|
|
Form
of 6% Secured Convertible Debenture issued in connection with Exhibit
4.12.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.12.3
|
|
Registration
Rights Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation and the investors named therein (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on November 12, 2004)
|
|||
|
|
|
|||
4.12.4
|
|
Form
of Additional Investment Right issued in connection with Exhibit
4.12.1
(incorporated by reference to Exhibit 4.5 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.12.5
|
|
Custodial
and Security Agreement, dated November 10, 2004, by and among Generex
Biotechnology Corporation, Feldman Weinstein LLP, as custodian,
and the
investors named therein (incorporated by reference to Exhibit 4.6
to
Generex Biotechnology Corporation’s Report on Form 8-K filed on November
12, 2004)
|
|||
|
|
|
|||
4.12.6
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
4.13
|
|
Termination
Agreement, dated December 17, 2004, by and among Generex Biotechnology
Corporation and Elan Corporation plc and Elan International Services,
Ltd.
(incorporated by reference to Exhibit 4.19 to Generex Biotechnology
Corporation’s Quarterly Report on Form 10-Q filed on June 14,
2005)
|
|||
|
|
|
|||
4.14
|
|
Warrant
issued to The Aethena Group, LLC on April 28, 2005 (incorporated
by
reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly
Report on Form 10-Q filed on June 14, 2005)
|
|||
|
|
|
|||
4.15.1
|
|
Amendment
No. 1 to Securities Purchase Agreement and Registration Rights
Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on June 17, 2005)
|
|||
|
|
|
|||
4.15.2
|
|
Form
of AIR Debenture issued in connection with Exhibit 4.15.1 (incorporated
by
reference to Exhibit 4.25.2 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.15.3
|
|
Form
of AIR Warrant issued in connection with Exhibit 4.15.1(incorporated
by
reference to Exhibit 4.25.3 to Generex Biotechnology Corporation’s Report
on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.15.4
|
|
Form
of Additional AIR issued in connection with Exhibit 4.15.1 (incorporated
by reference to Exhibit 4.25.4 to Generex Biotechnology Corporation’s
Report on Form 10-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.16.1
|
|
Amendment
No. 2 to Securities Purchase Agreement and Registration Rights
Agreement
entered into by and between Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9,
2005)
|
65
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.16.2
|
|
Form
of Air Debenture issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.16.3
|
|
Form
of AIR Warrant issued in connection with Exhibit 4.16.1 (incorporated
by
reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.16.4
|
|
Form
of Additional AIR issued in connection with Exhibit 4.16.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on September 9, 2005)
|
|||
|
|
|
|||
4.17
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on October
27, 2005
(incorporated by reference to Exhibit 4.31 to Generex Biotechnology
Corporation’s Report on Form 10-K filed on October 31,
2005)
|
|||
|
|
|
|||
4.18.1
|
|
Amendment
to the Additional Investment Right issued by Generex Biotechnology
Corporation to Omicron Master Trust on June 17, 2005 (incorporated
by
reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on October 31, 2005)
|
|||
|
|
|
|||
4.18.2
|
|
Additional
AIR Debenture issued by Generex Biotechnology Corporation to Omicron
Master Trust on October 27, 2005 issued in connection with Exhibit
4.18.1
(incorporated by reference to Exhibit 4.37 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|
|||
4.18.3
|
|
Additional
AIR Warrant issued by Generex Biotechnology Corporation to Omicron
Master
Trust on October 27, 2005 issued in connection with Exhibit 4.18.1
(incorporated by reference to Exhibit 4.38 to Generex Biotechnology
Corporation’s Report on Form 10-Q filed on December 15,
2005)
|
|||
|
|
|
|||
4.19.1
|
|
Amendment
No. 3 to Securities Purchase Agreement and Registration Rights
Agreement
entered into by and among Generex Biotechnology Corporation and
the
Purchasers listed on the signature pages thereto (incorporated
by
reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.2
|
|
Form
of AIR Debentures issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.3
|
|
Form
of AIR Warrants issued in connection with Exhibit 4.19.1 (incorporated
by
reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on
Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.19.4
|
|
Form
of Additional AIRs issued in connection with Exhibit 4.19.1 (incorporated
by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report
on Form 8-K filed on December 5, 2005)
|
|||
|
|
|
|||
4.20
|
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on June 17, 2005 in connection with the
First
AIR Exercise (incorporated by reference to Exhibit 4.2 to Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|
|||
4.21
|
|
Form
of Amendment to the Additional Investment Right issued by Generex
Biotechnology Corporation on September 8, 2005 in connection with
the
Second AIR Exercise (incorporated by reference to Exhibit 4.3 to
Generex
Biotechnology Corporation’s Report on Form 8-K filed on December 5,
2005)
|
|||
|
|
|
|||
4.22
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on January
23, 2006
(incorporated by reference to Exhibit 4.2 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on January 24,
2006)
|
66
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.23
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and
Cranshire
Capital L.P. dated February 27, 2006 (incorporated by reference
to Exhibit
4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
|
|
|
|||
4.24
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and
Omicron
Master Trust dated February 27, 2006 (incorporated by reference
to Exhibit
4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.25
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and
Iroquois
Capital L.P. dated February 27, 2006 (incorporated by reference
to Exhibit
4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on
February 28, 2006).
|
|||
4.26
|
|
Agreement
to amend Warrants between Generex Biotechnology Corporation and
Smithfield
Fiduciary LLC dated February 27, 2006 (incorporated by reference
to
Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K
filed on February 28, 2006).
|
|||
4.27
|
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).
|
||||
4.28
|
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).
|
||||
4.29
|
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).
|
||||
4.30
|
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).
|
||||
4.31
|
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).
|
||||
4.32
|
|
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)
|
|||
4.33
|
|
Warrant
issued by Generex Biotechnology Corporation on April 17, 2006 to
Zapfe
Holdings, Inc.
|
|||
4.34
|
|
Form
of Warrant issued by Generex Biotechnology Corporation on April
17, 2006
to certain employees.
|
|||
4.35
|
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)
|
67
Exhibit
|
|
|
|||
Number
|
Description
of Exhibit
|
4.36
|
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)
|
||||
4.37
|
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)
|
||||
4.38
|
Form
of Warrant issued by Generex Biotechnology Corporation on June
1, 2006 in
connection with Exhibit 4.37 (incorporated by reference to Exhibit
4.4 to
Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2,
2006)
|
||||
9
|
|
Form
of Voting Agreement entered into in connection with Exhibit 4.12.1
(incorporated by reference to Exhibit 4.7 to Generex Biotechnology
Corporation’s Report on Form 8-K filed on November 12,
2004)
|
|||
|
|
|
|||
31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|||
|
|
|
|||
31.2
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
|||
|
|
|
|||
32
|
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant
to Section
906 of the Sarbanes-Oxley Act of
2002
|
(1) In
the case of incorporation by reference to documents filed by the
Registrant under the Exchange Act, the Registrant’s file number under the
Exchange Act is 000-25169.
|
68