Colorado
(State
or other jurisdiction
of
incorporation or organization) |
2836
(Primary
Standard Industrial
Classification
Code Number) |
841521955
(I.R.S.
Employer
Identification
No.) |
Title
of each class of
securities
to be registered |
Amount
to be Registered (1) |
Proposed
maximum offering
price per unit (2) |
Proposed
maximum aggregate offering price (2) |
Amount
of
registration
fee |
common
stock par value $0.001 per share(3) |
36,690,056 |
$1.00 |
$4,318.42 |
$4,318.42 |
common
stock par value $0.001 per share(4) |
19,630,588 |
$1.00 |
$2,310.52 |
$2,310.52 |
(1)
|
In
accordance with Rule 416(a), the Registrant is also registering hereunder
an indeterminate number of shares that may be issued and resold to prevent
dilution resulting from stock splits, stock dividends or similar
transactions as well as anti-dilution provisions applicable to shares
underlying the warrants.
|
(2)
|
Estimated
pursuant to Rule 457(c) of the Securities Act of 1933 solely for the
purpose of computing the amount of the registration fee.
|
(3)
|
Represents
shares of the Registrant’s common stock being registered for resale that
have been issued to the selling stockholders named in the prospectus or a
prospectus supplement.
|
(4)
|
Represents
shares of the Registrant’s common stock being registered for resale that
have been or may be acquired upon the exercise of warrants issued to the
selling stockholders named in the prospectus or a prospectus
supplement.
|
The
information in this prospectus is not complete and may be changed without
notice. The selling stockholders may not sell these securities
until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to
sell these securities, and it is not soliciting offers to buy these
securities, in any state where the offer or sale of these securities is
not permitted. |
Item
Description |
Page
No. |
PROSPECTUS
SUMMARY |
iii |
THE
OFFERING |
ix |
RISK
FACTORS |
x |
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS |
xxv |
USE
OF PROCEEDS |
xxvi |
MARKET
FOR COMMON STOCK AND RELATED STOCKHOLDER MATTERS |
xxvi |
DIVIDEND
POLICY |
xxvi |
DILUTION |
xxvi |
CAPITALIZATION |
xxvii |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
AND PLAN OF OPERATIONS |
xxix |
BUSINESS |
39 |
MANAGEMENT |
55 |
PRINCIPAL
AND MANAGEMENT STOCKHOLDERS |
64 |
CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS |
67 |
SELLING
STOCKHOLDERS |
69 |
DESCRIPTION
OF CAPITAL STOCK OF THE COMPANY |
81 |
SHARES
OF THE COMPANY ELIGIBLE FOR FUTURE SALE |
83 |
PLAN
OF DISTRIBUTION |
85 |
LEGAL
MATTERS |
87 |
EXPERTS |
87 |
ADDITIONAL
INFORMATION |
87 |
FINANCIAL
STATEMENTS |
F-1 |
INFORMATION
NOT REQUIRED IN PROSPECTUS |
II-1 |
INDEMNIFICATION
OF DIRECTORS AND OFFICERS |
II-1 |
OTHER
EXPENSES OF ISSUANCE AND DISTRIBUTION |
II-1 |
RECENT
SALES OF UNREGISTERED SECURITIES |
II-1 |
EXHIBITS |
II-2 |
UNDERTAKINGS |
II-5 |
Product |
Indication |
Stage | ||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in the first half
of 2005*
| ||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in 2006
|
Lovaxin
NY
|
Ovarian,
melanoma and lung cancer
|
Pre-clinical;
Phase I study anticipated to commence in 2006
| ||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical;
Phase I study anticipated to commence in 2006
| ||
Lovaxin
T
|
Cancer
through control of telomerase
|
Pre-clincial
| ||
Lovaxin
H
|
Prophylactic
vaccine for HIV (AIDS)
|
Pre-clincial
|
· |
Initiate
and complete Phase I clinical study of Lovaxin C; |
· |
Continue
the pre-clinical development of our product candidates, as well as
continue research to expand our technology platform;
and |
· |
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies. |
Period
from March 1, 2002 (inception) to
December
31, |
Year
ended December 31, |
Ten
Months Ended October 31, |
Three
Months Ended January 31,
(unaudited) |
|||||||||||||||||||
Statement
of Operations Data: |
||||||||||||||||||||||
2002 |
2003 |
Unaudited
2003 |
2004 |
2004 |
2005 |
|||||||||||||||||
Total
operating expenses |
$ |
167,902 |
$ |
897,076 |
821,725 |
650,310 |
$ |
132,241 |
$ |
245,126 |
||||||||||||
Interest
expense (income) |
-- |
17,190 |
7288 |
4229 |
10,655
|
2,968 |
||||||||||||||||
Other
income |
966 |
4,521 |
4,106 |
116,462 |
(430 |
) |
(2,739 |
) | ||||||||||||||
Provision
for income taxes |
-- |
-- |
-- |
-- |
-- |
-- |
||||||||||||||||
Net
loss |
$ |
(166,936 |
) |
$ |
(909,745 |
) |
(825,907 |
) |
(538,076 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) | ||||||
Loss
per Share Information: |
||||||||||||||||||||||
Basic
and diluted net loss per share |
$ |
(0.01 |
) |
$ |
(0.05 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
Balance
Sheet Data: |
December
31, |
December
31, |
October
31 |
January
31, (unaudited) |
|||||||||
2002 |
2003 |
2004 |
2005 |
||||||||||
Cash
and cash equivalents |
$ |
204,382 |
$ |
47,160 |
$ |
32,279 |
$ |
3,217,430 |
|||||
Intangible
assets |
-- |
$ |
277,243 |
$ |
469,803 |
$ |
666,447 |
||||||
Total
assets |
$ |
204,382 |
$ |
324,403 |
$ |
502,083 |
$ |
3,886,327 |
|||||
Total
liabilities |
$ |
125,825 |
$ |
1,131,138 |
$ |
1,841,579 |
$ |
923,517 |
|||||
Stockholders’
equity (deficiency) |
78,557 |
(806,735 |
) |
$ |
(1,339,496 |
) |
2,962,810 |
Common
stock offered by selling stockholders |
56,320,644(1) |
Common
stock outstanding |
36,690,056
(2) |
Use
of proceeds |
We
will not receive any proceeds from the sale of the common stock, but we
will receive funds from the exercise of warrants by selling stockholders,
if exercised for cash. |
“OTC
Bulletin Board Quote” |
None |
(1) |
Represents
36,690,056 shares
of common stock that were issued to selling stockholders and
19,630,588 shares
of common stock underlying warrants that were issued to selling
stockholders. |
(2) | The number of shares of common stock outstanding as of January 31, 2005 listed above excludes |
· |
2,182,894
shares of common stock issuable upon exercise of
options; |
· |
20,302,582
shares of common stock issuable upon exercise of warrants with exercise
prices ranging from $0.1952 to $0.40 per
share; |
· |
Commitments
to issue stock, options or warrants. |
· |
competition
from companies that have substantially greater assets and financial
resources than we have; |
· |
need
for acceptance of products; |
· |
ability
to anticipate and adapt to a competitive market and rapid technological
developments; |
· |
amount
and timing of operating costs and capital expenditures relating to
expansion of our business, operations and
infrastructure; |
· |
need
to rely on multiple levels of outside funding due to the length of the
product development cycles and governmental approved protocols associated
with the pharmaceutical industry; and |
· |
dependence
upon key personnel including key independent consultants and
advisors. |
· |
The
number of and the outcome of clinical studies we are planning to conduct.
For example, our R&D expenses may increase based on the number of
late-stage clinical studies which we may be required to
conduct; |
· |
The
number of products entering into development from late-stage research. For
example, there is no guarantee that internal research efforts will succeed
in generating sufficient data for us to make a positive development
decision or that an external candidate will be available on terms
acceptable to us. Some promising candidates may not yield sufficiently
positive pre-clinical results to meet our stringent development
criteria; |
· |
In-licensing
activities, including the timing and amount of related development funding
or milestone payments. For example, we may enter into agreements requiring
us to pay a significant up-front fee for the purchase of in-process
research and development which we may record as an R&D
expense; |
· |
As
part of our strategy, we invest in R&D. R&D as a percent of future
potential revenues can fluctuate with the changes in future levels of
revenue. Lower revenues can lead to more limited spending on R&D
efforts; and |
· |
Future
levels of revenue. |
· |
Pre-clinical
study results that may show the product to be less effective than desired
(e.g., the study failed to meet its primary objectives) or to have harmful
or problematic side effects; |
· |
Failure
to receive the necessary regulatory approvals or a delay in receiving such
approvals. Among other things, such delays may be caused by slow
enrollment in clinical studies, length of time to achieve study endpoints,
additional time requirements for data analysis, or BLA preparation,
discussions with the FDA, an FDA request for additional pre-clinical or
clinical data, or unexpected safety or manufacturing
issues. |
· |
Manufacturing
costs, pricing or reimbursement issues, or other factors that make the
product uneconomical; and |
· |
The
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized. |
· |
significant
time and effort from our management team; |
· |
coordination
of our research and development programs with the research and development
priorities of our collaborators; and |
· |
effective
allocation of our resources to multiple
projects. |
· |
decreased
demand for our product candidates, |
· |
injury
to our reputation, |
· |
withdrawal
of clinical trial participants, |
· |
costs
of related litigation, |
· |
substantial
monetary awards to patients or other claimants,
|
· |
loss
of revenues, |
· |
the
inability to commercialize product candidates,
and |
· |
increased
difficulty in raising required additional funds in the private and public
capital markets. |
· |
price
and volume fluctuations in the overall stock market from time to time;
|
· |
fluctuations
in stock market prices and trading volumes of similar companies;
|
· |
actual
or anticipated changes in our earnings or fluctuations in our operating
results or in the expectations of securities analysts;
|
· |
general
economic conditions and trends; |
· |
major
catastrophic events; |
· |
sales
of large blocks of our stock; |
· |
departures
of key personnel; |
· |
changes
in the regulatory status of our product candidates, including results of
our clinical trials; |
· |
events
affecting Penn or any future collaborators;
|
· |
announcements
of new products or technologies, commercial relationships or other events
by us or our competitors; |
· |
regulatory
developments in the United States and other countries;
|
· |
failure
of our common stock to be listed quoted on the Nasdaq Small Cap Market,
American Stock Exchange, OTC Bulletin Board or other national market
system; |
· |
changes
in accounting principles; and |
· |
discussion
of us or our stock price by the financial and scientific press and in
online investor communities. |
· |
with
a price of less than $5.00 per share; |
· |
that
are not traded on a “recognized” national exchange;
|
· |
whose
prices are not quoted on the NASDAQ automated quotation system; or
|
· |
of
issuers with net tangible assets less than $2,000,000 (if the issuer has
been in continuous operation for at least three years) or $5,000,000 (if
in continuous operation for less than three years), or with average
revenue of less than $6,000,000 for the last three years.
|
· |
obtain
from the investor information about his or her financial situation,
investment experience and investment objectives;
|
· |
reasonably
determine, based on that information, that transactions in penny stocks
are suitable for the investor and that the investor has enough knowledge
and experience to be able to evaluate the risks of “penny stock”
transactions; |
· |
provide
the investor with a written statement setting forth the basis on which the
broker-dealer made his or her determination; and
|
· |
receive
a signed and dated copy of the statement from the investor, confirming
that it accurately reflects the investor’s financial situation, investment
experience and investment objectives. |
· |
The
issuance of new equity securities pursuant to a future
offering; |
· |
Changes
in interest rates; |
· |
Competitive
developments, including announcements by competitors of new products or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital commitments; |
· |
Variations
in quarterly operating results |
· |
Change
in financial estimates by securities
analysts; |
· |
The
depth and liquidity of the market for our common
stock; |
· |
Investor
perceptions of our company and the technologies industires generally;
and |
· |
General
economic and other national conditions. |
· |
statements
as
to the anticipated timing of clinical studies and other business
developments; |
· |
statements
as
to the development of new products; |
· |
expectations
as
to the adequacy of our cash balances to
support our operations for specified periods of time and as to the nature
and level of cash expenditures; and |
· |
expectations
as
to the market opportunities for our products, as well as our ability to
take advantage of those opportunities. |
· |
Our
limited operating history and ability to continue as a going
concern; |
· |
Our
ability to successfully develop and commercialize products based on our
therapies and the Listeria System; |
· |
A
lengthy approval process and the uncertainty of FDA and other government
regulatory requirements may have a material adverse effect on our ability
to commercialize our aplications; |
· |
Clinical
trials may fail to demonstrate the safety and effectiveness of our
applications or therapies, which could have a material adverse effect on
our ability to obtain government regulatory
approval; |
· |
The
degree and nature of our competition; |
· |
Our
ability to employ and retain qualified employees;
and |
· |
The
other factors referenced in this prospectus, including, without
limitation, under the section entitled “Risk Factors”, “Management’s
Discussion and Analysis of Financial Condition and Results of Operations
and Plan of Operations”, and Business”. |
Actual (Unaudited) |
||||
Long-term
debt |
$ |
230,000 |
||
Stockholders’
equity (deficit): |
||||
Common
stock |
36,690 |
|||
Additional
paid in capital |
4,830,116 |
|||
Deferred
compensation |
------ |
|||
Retained
earnings (deficit) |
($1,903,996 |
) | ||
Total
stockholders equity |
$ |
2,962,810 |
||
Total
capitalization |
$ |
3,192,810* |
Period
from March 1, 2002 (inception) to
December
31, |
Year
ended December 31, |
Ten Months Ended October 31, | Three Months Ended January
31,
(unaudited) |
||||||||||||||||
Statement of Operations Data: | |||||||||||||||||||
2002 |
|
|
2003 |
|
|
Unaudited
2003 |
|
|
2004 |
|
|
2004 |
|
|
2005 |
||||
Total
operating expenses |
$ |
167,902 |
$ |
897,076 |
821,725 |
650,310 |
$ |
132,241 |
$ |
245,126 |
|||||||||
Interest
expense (income) |
-- |
17,190 |
7,288 |
4,229 |
10,655
|
2,968 |
|||||||||||||
Other
income |
966 |
4,521 |
4,106 |
116,462 |
(430 |
) |
(2,739 |
) | |||||||||||
Provision
for income taxes |
-- |
-- |
-- |
-- |
-- |
-- |
|||||||||||||
Net
loss |
$ |
(166,936 |
) |
$ |
(909,745 |
) |
(825,907 |
) |
(538,076 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) | |||
Loss
per Share Information: |
|||||||||||||||||||
Basic
and diluted net loss per share |
$ |
(0.01 |
) |
$ |
(0.05 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
December
31, |
December
31, |
October
31 |
January
31, (unaudited) |
||||||||||
Balance
Sheet Data: |
|||||||||||||
2002 |
2003 |
2004 |
2005 |
||||||||||
Cash
and cash equivalents |
$ |
204,382 |
$ |
47,160 |
$ |
32,279 |
$ |
3,217,430 |
|||||
Intangible
assets |
-- |
$ |
277,243 |
$ |
469,803 |
$ |
666,447 |
||||||
Total
assets |
$ |
204,382 |
$ |
324,403 |
$ |
502,083 |
$ |
3,886,327 |
|||||
Total
liabilities |
$ |
125,825 |
$ |
1,131,138 |
$ |
1,841,579 |
$ |
923,517 |
|||||
Stockholders’
equity (deficiency) |
78,557 |
(806,735 |
) |
$ |
(1,339,496 |
) |
2,962,810 |
· |
Initiate
and complete phase I clinical study of Lovaxin C;
|
· |
Continue
pre-clinical development of our products; |
· |
Continue
research to expand our technology platform. |
· |
Cost
incurred to date: approximately $700,000 |
· |
Estimated
future costs: $1,000,000 |
· |
Anticipated
completion date: second quarter of 2006 |
· |
Risks
and uncertainties: |
– |
the
FDA (or relevant foreign regulatory authority) may not approve the
study |
– |
any
adverse event in a patient in the trial |
– |
difficulty
in recruiting patients |
– |
delays
in the program |
– |
strong
side effects in patients in the trial
|
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to a
marketing collaberation subject to regulatory approval to market and sell
the product. |
· |
Cost
incurred to date: $100,000 |
· |
Estimated
future costs: $1,800,000 |
· |
Anticipate
completion dates: second quarter of 2007 |
· |
Risks
and uncertainties: |
– |
Obtaining
favorable animal data |
– |
Proving
low toxicity in animals and
obtaining favorable animal data |
– |
Manufacturing
scale up to GMP level |
– |
FDA
(or foreign regulatory authority) may not approve the
study |
– |
The
occurrence of an adverse event in a patient |
– |
Delays
in the program |
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage, upon a licensing deal or pursuant to a marketing
collaberation subject to regulatory approval to market and sell the
product. |
· |
Cost
incurred to date: None |
· |
Estimated
future costs: $1,500,000 |
· |
Anticipate
completion dates: third quarter of 2007 |
· |
Risks
and uncertainties: |
– |
Obtaining
favorable animal data |
– |
Proving
low toxicity in animals and obtaining favorable animal
data |
– |
Manufacturing
scale up to GMP levels |
– |
FDA
(or foreign regulatory authority) may not approve the study
initiation |
– |
Adverse
event in a patient in the program |
– |
Delays
in the program |
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to a
maekting collaberation subject to regulatory approval to market and sell
the product. |
· |
Cost
incurred to date: $100,000 |
· |
Estimated
future costs: Unknown at this stage. |
· |
Anticipated
completion dates: Unknown at this stage. |
· |
Risks
and uncertainties: |
– |
Obtaining
favorable animal data |
– |
Proving
low toxicity in animals and obtaining favorable animal
data |
– |
Manufacturing
scale up to GMP levels |
– |
FDA
(or foreign regulatory authority) may not approve the
study |
– |
The
occurrence of an adverse event in a patient in the
program |
– |
Delays
in the program |
· |
Commencement
of material cash flows: |
– |
Unknown
at this stage and dependent upon a licensing deal or pursuant to a
marketing collaberation subject to regulatory approval to market and sell
the product. |
· |
an
increase in our related manufacturing expenses of $189,947 or 10,629% from
$1,787 to $191,734; such decrease reflects the delay in the manufacturing
program during 2004 because of delays in
funding; |
· |
an
increase in expenses related to toxicology studies from $0 to $27,216;
such increase reflects the initiation of toxicology studies by Pharm Olam
in connection with our Lovaxin C product candidates, and the payment of
deferred license fees to Penn; |
· |
employee
related expenses increased by $18,720, or 43.90%, from $42,670 for the
three months ended January 31, 2004 to $61,390 for the three months ended
January 31, 2005 arising from a bonus to Mr. Derbin, the Chief Executive
Officer, in stock; |
· |
professional
fees decreased by $89,670 from $14,102 for the three-months ended January
31, 2004 to $(75,568) for the three months ended January 31, 2005
principally due to (a) an increase in consulting fees from $13,000 to
$63,259, and (b) a decrease in legal fees from $832 for the three-months
ended January 31, 2004 to ($166,346) for the three months ended January
31, 2005, as a result of a settlement with the Company’s Intellectual
Property law firm which resulted in a reduction by approximately $177,000
of accounts payable previously recorded as legal fee expense;
and |
· |
Option
expense was reduced from $8,484 for the three months ended January 31,
2004 to $0 for the three months ended January 31,
2005. |
General
and
Administrative
Expenses |
Three
Months Ended January 31, |
||||||||||||
2005 |
2004 |
Net
Change |
%
Change |
||||||||||
Option
expense |
- |
8,484 |
(8,484 |
) |
-100.00 |
% | |||||||
Accounting |
21,853 |
- |
21,853 |
100.00 |
% | ||||||||
Consulting
Fees |
63,250 |
13,000 |
51,250 |
394.20 |
% | ||||||||
Legal
Fees |
(166,346 |
) |
832 |
(167,178 |
) |
-20093.50 |
% | ||||||
Payroll
Fees |
371 |
271 |
100 |
37.00 |
% | ||||||||
Insurance |
5,398 |
- |
5,398 |
100.00 |
% | ||||||||
Employee
Costs |
61,391 |
42,670 |
18,720 |
43.90 |
% |
· |
A
decrease in our manufacturing expenses of $228,452 or 103.9% from $219,948
to $(8,504); such decrease reflects the delay in the manufacturing program
during 2004 because of delays in funding; |
· |
A
decrease in our License Fees of $110,164 or 196.4% from $56,082 to
$(54,082); such decrease reflects the reclassification of License Fees
from an R&D expense to an investment; |
· |
A
decrease in our outside research fees from $97,306 to $38,382; such
decrease reflects the completion in year 2004 of our expenses resulting
from our sponsored research agreement with
Penn; |
· |
employee
related expenses increased by $34,790, or 22.5%, from $154,512 for the ten
months ended October 31, 2003 to $189,302 for the ten months ended October
31, 2004 arising from a bonus to Mr. Derbin, the Chief Executive Officer,
in stock; |
· |
professional
fees increased by $14,368 from $204,145 for the ten months ended October
31, 2003 to $218,514 for the ten months ended October 31, 2004 principally
due to (a) an increase in consulting fees from $95,651 to $110,332, and
(b) an increase in accounting fees from $350 to $23,070;
and |
· |
Insurance
expense was increased from $1,901 for the ten months ended October 31,
2003 to $9,929 for the ten months ended October 31,
2004. |
Product |
Indication |
Stage | ||
Lovaxin
C
|
Cervical
and head and neck cancers
|
Pre-clinical;
Phase I study in cervical cancer anticipated to commence in the first half
of 2005*
| ||
Lovaxin
B
|
Breast
cancer and melanoma
|
Pre-clinical;
Phase I study anticipated to commence in 2006
| ||
Lovaxin
NY
|
Ovarian,
melanoma and lung cancer
|
Pre-clinical;
Phase I study anticipated to commence in 2006
| ||
Lovaxin
W
|
Wilms
tumor and leukemia
|
Pre-clinical;
Phase I study anticipated to commence in 2006
| ||
Lovaxin
T
|
Cancer
through control of telomerase
|
Pre-clincial
| ||
Lovaxin
H
|
Prophylactic
vaccine for HIV (AIDS)
|
Pre-clincial
|
· |
Initiate
and complete Phase I clinical study of Lovaxin C; |
· |
Continue
the pre-clinical development of our product candidates, as well as
continue research to expand our technology platform;
and |
· |
Initiate
strategic and development collaborations with biotechnology and
pharmaceutical companies. |
· |
optimized
the Listeria strain to be used; |
· |
identified
and contracted with a manufacturing partner for material manufactured in
accordance with “good manufacturing practices” or “GMP” as established by
the FDA; |
· |
identified
a principal investigator for the trial; |
· |
written
a protocol; and |
· |
commenced
preparing an investigational new drug application, or IND, with an
external consulting group. |
Product |
Indication |
Stage | ||
Lovaxin
C |
Cervical
and neck cancers |
Pre-clinincal;
Phase I study in cervical cancer anticipated to commence in the first half
of 2005* | ||
Lovaxin
B |
Breast
cancer and melanoma |
Pre-clinical;
Phase I study anticipated to commence in 2006 | ||
Lovaxin
NY |
Ovarian
melanoma and lung cancer |
Pre-clinical;
Phase I study anticipated to commence in 2006 | ||
Lovaxin
W |
Wilms
tumor and leukemia |
Pre-clinical;
Phase I study anticipated to commence in 2006 | ||
Lovaxin
T |
Cancer
through control of telomerase |
Pre-clinical | ||
Lovaxin
H |
Prophylactic
vaccine for HIV (AIDS) |
Pre-clinical | ||
United
States | |
Patents | |
U.S.
Patent No. 6,051,237, issued April 18, 2000. Patent Application No.
08/336,372, filed November 8, 1994 for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector.” Filed November 8,
1994. Expires April 18, 2017. | |
U.S.
Patent No. 6,565,852, issued May 20, 2003, Paterson, et al., CIP Patent
Application No. 09/535,212, filed March 27, 2000 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector.” Filed March 27, 2000. Expires May 20, 2020. | |
U.S.
Patent No. 6,099,848, issued August 8, 2000. Frankel et al., Patent
Application No. 08/972,902 “Immunogenic Compositions Comprising DAL/DAT
Double-Mutant, Auxotrophic, Attentuated Strains of Listeria and Their
Methods of Use.” Filed November 18, 1997. Expires November 18,
2017. | |
U.S.
Patent No. 6,504,020, issued January 7, 2003 of Divisional Application No.
09/520,207 “Isolated Nucleic Acids Comprising Listeria DAL And DAT Genes”.
Filed March 7, 2000., Frankel et al. Expires March 7,
2020. | |
U.S.
Patent No. 6,635,749, issued October 21, 2003; Divisional U.S. Patent
Application No. 10/136,253 for “Isolated Nucleic Acids Comprising Listeria
DAL and DAT Genes.” Filed May 1, 2002, Frankel, et al. Filed May 1,
2022. | |
U.S.
Patent No. 5,830,702, issued November 3, 1998. Patent Application No.
08/366,477, filed December 30, 1994 for “Live, Recombinant Listeria SSP
Vaccines and Productions of Cytotoxic T Cell Response” Portnoy, et al.
Filed December 30, 1997. Expires November 3, 2015. | |
US
Patent No. 6,767,542 issued July 27, 2004, Paterson, et al. Patent
Application No. 09/735,450 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed December 13, 2000. Expires March 29,
2020. |
Patent
Applications | |
U.S.
Patent Application No. 10/441,851, “Methods And Compositions For
Immunotherapy of Cancer,” Filed May 20, 2003, Paterson et
al. | |
U.S.
Patent Application No. 10/239,703 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed September 24, 2002, Paterson,
et al. | |
Patent
Application No. 09/537,642 for “Fusion of Non-Hemolytic, Truncated Form of
Listeriolysis o to Antigens to Enhance Immunogenicity.” Filed March 29,
2000. Paterson, et al. | |
U.S.
Patent Application No. 10/660,194, “Immunogenic Compositions Comprising
DAL/DAT Double Mutant, Auxotrophic Attenuated Strains Of Listeria And
Their Methods Of Use,” Filed September 11, 2003, Frankel et
al. |
International | |
Patents | |
Australian
Patent No. 730296, Patent Application No. 14108/99 for “Bacterial Vaccines
Comprising Auxotrophic, Attenuated Strains of Listeria Expressing
Heterologous Antigens.” Filed May 18, 2000. Frankel, et
al. | |
Patent
Applications | |
Canadian
Patent Application No. 2,204,666, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson et al. | |
Canadian
Patent Application No. 2,309,790 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al. | |
Canadian
Patent Application No. 2,404,164 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al. | |
European
Patent Application No. 95939926.2, for “Specific Immunotherapy of Cancer
Using a Live Recombinant Bacterial Vaccine Vector”. Filed November 3,
1995, Paterson, et al. | |
European
Patent Application No. 01928324.1 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001. Paterson, et
al. | |
European
Patent Application No. 98957980.0 for “Bacterial Vaccines Comprising
Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous
Antigens.” Filed May 18, 2000, Frankel, et al. | |
Israel
Patent Application No. 151942 for “Compositions and Methods for Enhancing
Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al. | |
Japanese
Patent Application No. 515534/96, filed November 3, 1995 for “Specific
Immunotherapy of Cancer Using a Live Recombinant Bacterial Vaccine
Vector”, Paterson, et al. | |
Japanese
Patent Application No. 2001-570290 for “Compositions and Methods for
Enhancing Immunogenicity of Antigens.” Filed March 26, 2001, Paterson, et
al. |
· |
who
must be recruited as qualified
participants; |
· |
how
often to administer the drug; |
· |
what
tests to perform on the participants; and |
· |
what
dosage of the drug to give to the
participants. |
Name |
Age |
Position | ||
J.
Todd Derbin(3) |
52 |
President,
Chief Executive Officer, and Director | ||
Dr.
James Patton(1) |
47 |
Chairman
of the Board of Directors | ||
Roni
A. Appel(3) |
38 |
Chief
Financial Officer, Secretary and Director | ||
Dr.
Thomas McKearn(2) |
55 |
Director | ||
Dr.
Steven Roth |
62 |
Director | ||
Scott
Flamm(1) (2) |
50 |
Director |
(1) |
Member
of the Audit Committee. | |
(2) |
Member
of the Compensation Committee. | |
(3) |
Member
of the Nominating and Corporate Governance Committee.
|
· |
reviewing
the
results of the audit engagement with the independent registered public
accounting firm; |
· |
identifying
irregularities
in the management of our
business in consultation with our independent accountants, and suggest an
appropriate course of action; |
· |
reviewing
the
adequacy, scope, and results of the internal accounting controls and
procedures; |
· |
reviewing
the
degree of independence of the auditors, as well as the nature and scope of
our relationship with our independent registered public accounting
firm; |
· |
reviewing
the
auditors’ fees; and |
· |
recommending
the
engagement of auditors to the full board of
directors. |
· |
identifying
and recommending to the board of directors individuals qualified to serve
as directors of the Company and on the committees of the board;
|
· |
advising
the board with respect to matters of board composition, procedures and
committees; |
· |
developing
and recommending to the board a set of corporate governance principles
applicable to us and overseeing corporate governance matters generally;
and |
· |
overseeing
the annual evaluation of the board and our management.
|
· |
Honest
and ethical conduct, including the ethical handling of actual or apparent
conflicts of interest between personal and professional
relationships; |
· |
Full,
fair, accurate, timely and understandable disclosure in reports and
documents that a we file with, or submit to, the SEC and in other public
communications made by us; |
· |
Compliance
with applicable governmental laws, rules and
regulations; |
· |
The
prompt internal reporting of violations of the code to an appropriate
person or persons identified in our code of ethics;
and |
· |
Accountability
for adherence to our code of ethics. |
Annual
Compensation |
Long
Term
Compensation
Awards | |||||||
Name
And Principal Position |
Year |
Salary($) |
Bonus($) |
Securities
Underlying Options | ||||
J.
Todd Derbin President, Chief Executive Officer, and Director |
2004
2003 |
$168,270
$150,000 |
$45,000**
$60,000** |
--
1,172,727 | ||||
Dr.
James Patton Chairman of the Board of Directors |
2004
2003 |
$-*
$-* |
--
-- |
29,583
33,810 |
*Dr.
Patton was paid consulting fees by Advaxis of $18,000 in 2003 and $15,750
in 2004.
Mr.
Patton’s compensation related to his consulting agreement which terminated
on November 2004.
**Mr.
Derbin’s stock option award was based in his employment contract. His 2003
bonus of $60,000 was paid in Common Stock of the Company on the basis of a
volume of $0.1452 per share and
was two-third’s of his maximum bonus of $90,000. The basis for this bonus
was the successful conclusion of several matters of great importance to
the Company including: |
-
|
negotiating
and executing an arrangement with GSK in
2003; |
-
|
extending
the patent portfolio and moving it to the care of competent patent
counsel; |
-
|
creating
grant opportunities for the company; |
- |
scaling
up manufacturing; |
-
|
creating
certain collaboration opportunities. |
Individual
Grants |
||||||||||||||
Number
Of Securities Underlying |
Percent Of Total Options Granted To |
Potential
Realizable Value At Assumed Annual Rates of Stock Price Appreciation For Option Term($) | ||||||||||||
Name |
Year |
Options Granted |
Employees
In Fiscal Year) |
Exercise Price |
Expiration Date |
5% |
10% | |||||||
J.
Todd Derbin(1) President, Chief Executive Officer, and Director |
2004 2003 |
-- -- |
-- -- |
-- -- |
-- -- |
-- -- |
-- -- | |||||||
Dr.
James Patton Chairman of the Board of Directors |
2004 2003 |
29,583 33,810 |
46.6% 53.3% |
$0.35 $0.35 |
11/1/2012 11/1/2012 |
$2,190
$2,503 |
$7,845
$8,966 |
Number
Of Securities Underlying Unexercised Options At Fiscal Year-End(2) |
Value
Of Unexercised In-The-Money Options At Fiscal Year-End($)(3) | |||||||||||||
Name |
Year |
Shares Acquired On Exercise |
Value Realized(1) |
Exercisable |
Unexercisable |
Exercisable |
Unexercisable | |||||||
J.
Todd Derbin President, Chief Executive Officer, and Director |
2004 2003 |
0 0 |
0 0 |
586,382 293,191 |
586,382 879,575 |
51,015 0 |
|
51,015 0 | ||||||
|
||||||||||||||
Dr.
James Patton Chairman of the Board of Directors |
2004 2003 |
0 0 |
0 0 |
29,583 33,810 |
0 0 |
0 0 |
0 0 |
(1) |
Based
on the
fair
market value
of
our
common stock on
the date of exercise, less the exercise price payable for such shares.
|
(2) |
Certain
of the options are immediately exercisable for all the option shares as of
the date of grant but any shares purchased are subject to repurchase by us
at the original exercise price
paid per share if
the optionee ceases service with us before vesting in such shares.
|
(3) |
Based
on the
fair
market value
of
our
common stock at
fiscal year end of $0.20
per
share, determined by the board to be equal to our Private Placement price
per share less
the exercise price payable for such shares.
|
· |
each
person
who is known by us to be the owner of record or beneficial owner of more
than 5% of our
outstanding common stock; |
· |
each
of
our directors and each of our executive officers;
|
· |
all
of
our directors and executive officers as
a group; and |
· |
the
number
of
shares
of common stock beneficially
owned
by each such person and such group and the percentage of the outstanding
shares owned by each such person and such
group. |
Name
and Address |
Number
of Shares of Registrant Common Stock Beneficially Owned |
Percentage
of Class Beneficially Owned(1) |
||||||
Name
and Address of Beneficial Owner |
Shares
of Common Stock Beneficially Owned |
Percentage
of Class Beneficially Owned |
||||||
J.
Todd Derbin(1)(2) |
1,837,348
(3 |
) |
4.81 |
% |
||||
Roni
Appel(1)(2) |
3,041,622
(4 |
) |
8.22 |
% |
||||
Scott
Flamm(1) |
2,914,989
(5 |
) |
7.90 |
% |
||||
Dr.
Steve Roth(1) |
82,763
(6 |
) |
0.02 |
% |
||||
Dr.
James Patton(1) |
2,913,476
(7 |
) |
7.92 |
% |
||||
Dr.
Thomas McKearn(1) |
306,601
(8 |
) |
0.08 |
% |
||||
The
Trustees of the University of Pennsylvania Center for Technology Transfer, University of Pennsylvania 3160 Chestnut Street, Suite 200 Philadelphia, PA 19104-6283 |
6,339,282
|
17.2 |
% |
Sunrise
Equity Partners, LP 641 Lexington Ave-25fl New York, NY 10022 |
1,835,491
(9 |
) |
4.99 |
% |
||||
Level
Counter, LLC c/o Sunrise Securities Corp. 641 Lexington Ave-25fl New York, NY 10022 |
1,835,491 (10 |
) |
4.99 |
% |
||||
Marilyn
Adler c/o Sunrise Securities Corp. 641 Lexington Ave-25fl New York, NY 10022 |
1,835,491 (11 |
) |
4.99 |
% |
||||
Nathan
Low c/o Sunrise Securities Corp. 641 Lexington Ave-25fl New York, NY 10022 |
3,346,311
(12 |
) |
9.10 |
% |
||||
Amnon
Mandelbaum c/o Sunrise Securities Corp. 641 Lexington Ave-25fl New York, NY 10022 |
2,932,803
(13 |
) |
7.97 |
% |
||||
Emigrant
Capital Corp. 6 East 43 Street, 8th Fl. New York, NY 10017 |
1,838,783
(14 |
) |
4.99 |
% |
||||
Harvest
Advaxis LLC 30052 Aventura, Suite C Rancho Santa Margarita, CA 92688 |
3,832,753(15 |
) |
10.4 |
% |
||||
All
Directors and Officers as a Group (6 people) |
11,096,799 |
28.95 |
% |
_____________________________________ | ||
* Based on 36,690,056 shares of common stock outstanding as of January 31, 2005. | ||
(1) |
Director | |
(2) |
Officer | |
(3) |
Reflects
295,766 shares of common stock, 1,172,767 options to purchase shares of
common stock and 368,815 warrants to purchase shares of common stock.
| |
(4) |
Reflects
14,449 warrants to purchase shares of common stock and 2,522,166 shares of
common stock owned by Mr. Appel but does not reflect 58,580 warrants to
purchase shares of common stock because such warrants are not under the
current circumstances, exercisable within the next 60 days. Also reflects
355,528 shares of common stock and 149,480 options and warrants to
purchase shares of common stock beneficially owned by Carmel Ventures,
Inc. of which Mr. Appel is a controlling person but does not reflect
355,528 warrants to purchase shares of common stock owned by Carmel
Ventures, Inc. because such warrants are not under the current
circumstances, exercisable within the next 60 days. | |
(5) |
Reflects
125,772 shares of common stock and 122,751 options and warrants to
purchase shares of common stock owned by Mr. Flamm but does not reflect
125,722 warrants to purchase shares of common stock because such warrants
are not under the current circumstances, exercisable within the next 60
days. Also reflects 2,621,325 shares of common stock and 45,141 warrants
to purchase shares of common stock beneficially owned by Flamm Family
Partners LP of which Mr. Flamm is a partner. | |
(6) |
Reflects
options to purchase shares of common stock. | |
(7) |
Reflects
56,349 options to purchase shares of common stock, 36,551 warrants to
purchase shares of common stock and 2,820,576 shares of common stock but
does not reflect 147,716 warrants to purchase shares of common stock
because such warrants are not under the current circumstances, exercisable
within the next 60 days. | |
(8) |
Reflects
195,586 options and warrants to purchase shares of common stock and
111,015 shares of common stock. |
(9) |
Reflects
1,742,160 shares of common stock held by Sunrise Equity Partners, LP
("SEP") and warrants to purchase 93,331 shares of common stock, but does
not include warrants to purchase 1,648,829 shares of common stock issuable
upon exercise of warrants held by SEP because such warrants are not, under
the current circumstances, exercisable within the next 60 days. The
General Partner of SEP is Level Counter, LLC ("LC"), the managers of which
are Nathan Low, Marilyn Adler and Amnon Mandelbaum (the
"Managers"). Decisions regarding voting and disposition require
the unanimous vote of all three managers. The 1,835,491
shares of common stock, beneficially held
by SEP also does not include: (1) 1,124,253 shares of common
stock directly owned by Nathan Low or warrants directly owned by Mr. Low
to purchase up to 761,971 shares of common stock; (2) 1,094,020 shares of
directly owned by Amnon Mandelbaum or warrants directly owned by Mr.
Mandelbaum to purchase up to 672,539 shares of common stock (which
warrants are not, under the circumstances, exercisable within the next 60
days), and (3) shares of common stock held by limited partners of SEP
or LC who may have a direct or indirect pecuniary interest, but have no
authority to vote or dispose of the shares of common stock held by SEP.
|
(10) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to
purchase 1,648,829 shares of common stock issuable upon exercise of
such warrants held by SEP because such warrants are not, under the
circumstances, exercisable within the next 60 days. LC is the general
partner of SEP and as such, is deemed to have beneficial ownership of the
securities held by SEP for purposes of calculating percentage interest.
However, LC disclaims beneficial interest in such shares except to the
extent of its pecuniary interest therein. | |
(11) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Ms. Adler is a manager of LC, the
general partner of SEP, and as such, is deemed to have beneficial
ownership of the securities held by SEP for purposes of calculating
percentage interest. However, Ms. Adler disclaims beneficial interest in
such shares except to the extent of her pecuniary interest
therein. | |
(12) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Mr. Low is a manager of LC, the
general partner of SEP, and as such, is deemed to have beneficial
ownership of the securities held by SEP for purposes of calculating
percentage interest. However, Mr. Low disclaims beneficial interest in
such shares except to the extent of his pecuniary interest therein. Also
reflects 1,124,253 shares of common stock owned by Mr. Low but does not
reflect warrants to purchase 761,971 shares of common stock issuable upon
exercise of such warrants because such warrants are not, under the
circumstances, exercisable within the next 60 days. Also includes 383,275
shares of common stock held by Sunrise Securities Corp., a corporation of
which Mr. Low is sole stockholder and director, but does not include
warrants to purchase 348,432 shares of common stock held by Sunrise
Securities Corp. because such warrants are not, under the circumstances,
exercisable within the next 60 days. Mr. Low’s beneficial ownership does
not include shares of common stock held by Sunrise Foundation Trust, a
charitable trust of which Mr. Low is a trustee. Mr. Low disclaims
beneficial ownership of such shares of common stock held by Sunrise
Foundation Trust. | |
(13) |
Reflects
1,742,160 shares of common stock held by SEP and warrants to purchase
93,331 shares of common stock, but does not include warrants to purchase
1,648,829 shares of common stock issuable upon exercise of such warrants
held by SEP because such warrants are not, under the circumstances,
exercisable within the next 60 days. Mr. Mandelbaum is a manager of LC,
the general partner of SEP, and as such, is deemed to have beneficial
ownership of the securities held by SEP for purposes of calculating
percentage interest. However, Mr. Mandelbaum disclaims beneficial interest
in such shares except to the extent of his pecuniary interest therein.
Also reflects 1,094,020 shares of common stock owned by Mr. Mandelbaum but
does not reflect warrants to purchase 672,539 shares of common stock
issuable upon exercise of such warrants because such warrants are not,
under the circumstances, exercisable within the next 60
days. |
(14) |
Reflects
1,742,160 shares of common stock held by Emigrant Capital Corp.
(“Emigrant”) and warrants to purchase 16,623 shares of common stock, but
does not include warrants to purchase 1,645,537 shares of common stock
issuable upon exercise of warrants held by Emigrant because such warrants
are not, under the current circumstances, exercisable within the next 60
days. | |
(15) |
Reflects
3,832,753 shares of common stock but does not reflect warrants to purchase
3,832,753 shares of common stock because such warrants are not currently
exercisable within the next 60
days. |
· |
36,690,056
shares of our common stock that were issued to selling stockholders
pursuant to transactions exempt from registration under the Securities Act
of 1933; and |
· |
19,630,588
shares of common stock underlying warrants that were issued to selling
stockholders pursuant to transactions exempt from registration under the
Securities Act of 1933. |
· |
J.
Todd Derbin has served as our Chief Executive Officer and a director since
November 12, 2004; |
· |
Roni
Appel has served as our Chief Financial Officer and a director since
November 12, 2004; Carmel Ventures, Inc., of which Mr. Appel is the
principal stockholder has provided consulting services to us; LVEP by
which Mr. Appel is employed, is providing consulting services to
us; |
· |
Scott
Flamm has served as a director since November 12, 2004 and LVEP of which
Mr. Flamm is a principal stockholder and an employee of, is providing
consulting services to us; |
· |
Thomas
McKearn has served as a director since November 12,
2004; |
· |
Dr.
James Patton has served as a director since November 12, 2004 and has
served as a consultant to us in the past; |
· |
Dr.
Yvonne Patton has served as a consultant; |
· |
The
Trustees of the University of Pennsylvania own the patents which we have
an exclusive license; |
· |
Sunrise
Securities Corp. acted as placement agent in the Private Placement. Nathan
Low, Amnon Mandelbaum, Marcia Kucher, Derek Caldwell, Richard Stone and
David Goodfriend are all affiliated with or employed by Sunrise Securities
Corp., the placement agent in the Private Placement. Sunrise
Equity Partners, LP and Sunrise Foundation Trust are also affiliates
of Sunrise Securities Corp.; and |
· |
Dr.
David Filer is a consultant for us and provided consulting services to the
Sunrise Securities Corp. |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Adele
Pfenninger
12
Spring Brook Road
Annandale,
NJ 08801 |
79,600
(1) |
70,790
(1) |
0.22% |
0.02% |
-- |
AI
International Corporate Holdings, Ltd.
c/o
FCIM Corp.
1
Rockefeller Plaza
Suite
1730
New
York, NY 10020 |
174,216
(2) |
174,216
(2) |
0.
47% |
0.0% |
-- |
Alan
Gelband Company
Defined
Contribution Pension Plan and Trust
30
Lincoln Plaza
New
York, NY 10023 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Alan
Kestenbaum
18
Clover Drive
Great
Neck, NY 11021 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Beretz
Family Partners LP
48
South Drive
Great
Neck, NY 11021 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Bridges
& Pipes, LLC
830
Third Avenue
14th
Floor
New
York, NY 10022 |
1,393,728
(4) |
1,393,728
(4) |
3.73% |
0.0% |
-- |
Bruce
Fogel
218
Everglade Avenue
Palm
Beach, FL 33480 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
C.
Leonard Gordon
551
Fifth Avenue
New
York, NY 10176 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
Carmel
Ventures, Inc
22
Ruth Lane
Demarest,
NJ 07627 |
860,537
(5) |
711,057
(5)(a) |
2.32% |
0.41% |
5(b) |
Catherine
Janus
4817
Creak Dr.
Western
Spring, IL 60558 |
118,832
(6) |
105,767
(6) |
0.32% |
0.04% |
-- |
Chaim
Cymerman
c/o
Tomer Cymerman
Paamoni
10, Apt. 19
Bavli,
Tel Aviv
Israel |
196,371
(7) |
174,593
(7)(a) |
0.53% |
0.06% |
-- |
Charles
Kwon
834
Monror Street
Evanston,
Il 60202 |
491,233
(8) |
482,322
(8)(a) |
1.33% |
0.02% |
-- |
Cranshire
Capital, LP
666
Dundee Road
Sute
1901
Northbrook,
IL 60602 |
1,045,296
(9) |
1,045,296
(9) |
2.81% |
0.0% |
-- |
Crestwood
Holdings, LLC
c/o
Ran Nizan
109
Boulevard Drive
Danbury,
CT 06810 |
360,253
(10) |
337,978
(10)(a) |
0.98% |
0.06% |
-- |
David
Stone
228
St. Charles Avenue
Suite
1024
New
Orleans, LA 70130 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
David
Tendler
401
East 60th
Street
New
York, NY 10022 |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Design
Investments, LTD
9
Tanbark Circuit
Suite
1442
Werrington
Downs
NSW
2747
Australia |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Emigrant
Capital Corp.
6
East 43rd
Street
8th
Floor
New
York, NY 10017 |
3,484,320
(12) |
3,484,320
(12) |
9.07% |
0.0% |
-- |
Eugene
Mancino
Blau
Mancino
12
Roszel Road, Suite C-101
Princeton,
NJ 08540 |
355,099
(13) |
212,544
(13)(a) |
0.96% |
0.39% |
-- |
Fawdon
Investments Ltd.
4
Ibn Shaprut Street
Jerusalem,
Israel 92478 |
1,393,728
(4) |
1,393,728
(4) |
3.73% |
0.0% |
-- |
Flamm
Family Partners, LP.
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078 |
2,666,466
(14) |
2,657,556
(14)(a) |
7.26% |
0.02% |
(14)(b) |
Fred
Berdon Co, LP
717
Post Road
Suite
105
Sacrsdale,
NY 10583 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Gina
Ferarri
36
Stone Run Road
Bedmingter,
NJ 07921 |
79,932
(15) |
71,022
(15)(a) |
0.22% |
0.2% |
-- |
Hal
H. Beretz
48
South Drive
Great
Neck, NY 11021 |
522,648
(16) |
522,648
(16) |
1.41% |
0.0% |
-- |
Howard
Kaye Family Fund
2
Mohican Trail
Scarsdale,
NY 10583 |
522,648
(16) |
522,648
(16) |
1.41% |
0.0% |
-- |
IRA
FBO / Walter S. Grossman Pershing LLC Custodian
277
North Ave.
Westport,
CT 06880 |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Itai
Portnio
26
Yakinton St.
Haifa,
Isreal 34406 |
157,608
(17) |
14,186
(17)(a) |
0.43% |
0.05% |
-- |
J.
Todd Derbin
840
Pretty Brook Road
Princeton,
NJ 08540 |
1,837,348 (18) |
591,532
(18)(a) |
4.81% |
3.28% |
(18)(b) |
James
Patton
1937
Swedesford
Malvern,
PA 19355 |
3,061,192
(19) |
2,968,291(19)(a) |
8.29% |
0.25% |
(19)(b) |
James
Paul
c/o
Fulwider Patton
Howard
Hughes Center
6060
Center Drive, 10th
Floor
Los
Angeles, CA 90045 |
39,215
(20) |
34,861
(20)(a) |
0.11% |
0.01% |
-- |
Jonas
Grossman
59
Huratio St.
New
York, NY 10014 |
80,640
(21) |
71,731
(21)(a) |
0.22% |
0.02% |
-- |
Kerry
Propper
59
Huratio St.
New
York, NY 10014 |
201,600
(22) |
179,326
(22)(a) |
0.55% |
0.06% |
-- |
Lilian
Flamm
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078 |
197,328
(23) |
197,328
(23) |
0.54% |
0.0% |
-- |
Marilyn
Mendell
1203
River Road,
Apt.
Penthouse 4
Edgewater,
NJ 07020 |
284,500
(24) |
253,316
(24)(a) |
0.77% |
0.08% |
-- |
Mary
Ann Ryan Francis
1115
Beanaqt Ave.
Seaside
Park, NJ 08752 |
79,071
(25) |
70,360
(25)(a) |
0.22% |
0.02% |
-- |
MEA
Group, LLC
145
Talmadge Road
Edison,
NJ 08817 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Mordechai
Mashiach
8
Shlomzion Hamalka
Haifa,
Isreal 34406 |
157,608
(17) |
140,186
(17)(a) |
0.43% |
0.05% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
New
Bank Ltd
Levinstein
Tower #21st
23
Menahem Begin Road
Tel
Aviv, Israel |
1,393,728
(4) |
1,393,728
(4) |
3.73% |
0.0% |
-- |
Open
Ventures LLC
127
West Chestnut Hill Ave.
Philadelphia,
PA 19118 |
17,422 |
17,422 |
0.05% |
0.0% |
-- |
Peggy
Fern
1548
Herlong Court
Rock
Hill, SC 29732 |
79,712
(26) |
70,081
(26)(a) |
0.22% |
0.02% |
-- |
Penn
Footware Retirement Trust
Line
& Grove Streets
PO
Box 87
Nanticoke,
PA 18634 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Richard
Yelovich
603
Milleson Lane
West
Chester, PA 19380 |
151,289
|
151,289 |
0.41% |
0.0% |
-- |
Roni
Appel
22
Ruth Lane
Demarest,
NJ 07627 |
2,595,193 (27) |
2,580,745
(27)(a) |
7.06% |
0.04% |
(27)(b) |
RP
Capital, LLC
10900
Wilshire Blvd.
Suite
500
Los
Angeles, CA 90024 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
Scott
Flamm
c/o
Scott Flamm
70
West Road
Short
Hills, NJ 07078 |
374,296
(28) |
251,545
(28)(a) |
1.01% |
0.33% |
(28)(b) |
Shai
Stern
43
Maple Aenue
Cedarhurst,
NY 11516 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
SRG
Capital, LLC
120
Broadway
40th
Floor
New
York, NY 10271 |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Sunrise
Equity Partners, LP
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
3,484,320
(12) |
3,484,320
(12) |
9.07% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Thomas
McKearn
6040
Lower Mountain Road
New
Hope, PA 18938 |
374,876
(29) |
269,839
(29)(a) |
1.02% |
0.29% |
(29)(b) |
Titan
Capital Management, LLC
(TCMP3
Partners)
7
Centure Drive
Suite
201
Parsippany,
NJ 07054 |
696,864
(11) |
696,864
(11) |
1.88% |
0.0% |
-- |
Tracy
Yun
90
LaSalle St., Apt. #13G
New
York, NY 10027 |
60,197
|
60,197 |
0.16% |
0.0% |
-- |
Trinita,
LLC
c/o
Morten Kielland
22
Painters Lane
Chesterbrook,
PA 19087 |
151,289
|
151,289 |
0.41% |
0.0% |
-- |
The
Trustees of the
University
of Pennsylvania
Center
for Technology Transfer
University
of Pennsylvania
3160
Chestnut Street
Suite
200
Philadelphia,
PA 19104-6283
Attn:
Managing Director |
6,339,282 |
6,339,282 |
17.28% |
0.0% |
(41) |
William
Kahn
7903
Longmeadow Road
Baltimore,
MD 21208 |
151,517 |
151,517 |
0.41% |
0.0% |
-- |
Yair
Talmor
517
Old Chappaqua Road
Briarcliff
Manor, NY 10510 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
Yoav
Millet
950
Third Avenue
New
York, NY 10022 |
174,216
(2) |
174,216
(2) |
0.47% |
0.0% |
-- |
Yvonne
Paterson
514
South 46 St.
Philadelphia,
PA 19143 |
873,412(30) |
704,365 |
2.37% |
0.46% |
|
Amnon
Mandelbaum
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
1,766,559
(31) |
1,766,559
(31) |
4.73% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
David
Goodriend
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
194,193
(32) |
194,193
(32) |
0.53% |
0.0% |
-- |
David
Filer
165
East 32 Street
New
York, NY 10016 |
382,772
(33) |
382,772
(33) |
1.04% |
0.0% |
(32)(a) |
Marcia
Kucher
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
4,140
(34) |
4,140
(34) |
0.01% |
0.0% |
-- |
Nathan
Low
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
1,886,224
(35) |
1,886,224
(35) |
5.04% |
0.0% |
-- |
Derek
Caldwell
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
153,658
(36) |
153,658
(36) |
0.42% |
0.0% |
-- |
Sunrise
Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
731,707(37)(37A) |
731,707
(37) |
1.98% |
0.0% |
(37)(a) |
Richard
Stone
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
307,317(38) |
307,317(38) |
0.83% |
0.0% |
-- |
Sunrise
Foundation Trust
c/o
Sunrise Securities Corp.
641
Lexington Avenue
25th
Floor
New
York, NY 10022 |
71,497(38)(a) |
71,497 |
0.19% |
0.0% |
-- |
Name |
Total
Shares
Owned |
Shares Registered |
%
Before Offering |
%
After Offering |
Relationship (if any) |
Martin
Trust Agreement
U/A/
DTD 11/05/01
Peter
L. Martin TTE
3757
Wedbster St, Apt 203
San
Francisco, CA 94123 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
A.
Heifetz Technologies Ltd
22
Kanfey Nesharim St
Jerusalem,
Israel 95464 |
348,432
(3) |
348,432
(3) |
0.95% |
0.0% |
-- |
Balestra
Spectrum Partners, LLC
1185
Avenue of the Americas
32nd
Floor
New
York, NY 10036 |
1,045,296
(9) |
1,045,296
(9) |
2.81% |
0.0% |
-- |
Reitler
Brown Holdings, LLC
800
Third Avenue
21st
Floor
New
York, NY 10022 |
60,000
(39) |
60,000
(39) |
0.16% |
0.0% |
(39)(a) |
|
|||||
Harvest
Advaxis LLC
30052
Aventura, Suite C
Rancho
Santa Margarita,
CA
92688 |
7,665,506
(40) |
7,665,506
(40) |
18.92% |
0.0% |
-- |
Miles
Wynn
P.O.
Box 440842
Aurora
, CO 80044 |
696,700 |
696,700 |
1.90% |
0.0% |
-- |
Teresa
Waz
3679
S. Dawson St.
Aurora,
CO 80444 |
26,900 |
26,900 |
0.07% |
0.0% |
-- |
|
|||||
Ormonde
Frew
19996
E. Greenwood Drive Aurora, CO 80013 |
12,000 |
12,000 |
0.03% |
0.0% |
-- |
|
|
||||
Ralph
Grills
4042
S. Atchison Way
Aurora,
CO 80014 |
12,000 |
12,000 |
0.03% |
0.0% |
-- |
Daniel
Unrein
281
S. Leyden St.
Denver,
CO 80220 |
2,500 |
2,500 |
0.01% |
0.0% |
-- |
Frederick
Malkhe
4105
E. Florida Ave.
Suite
100
Denver,
CO 80222 |
2,500 |
2,500 |
0.01% |
0.0% |
-- |
(1) |
Reflects
35,395 shares of common stock 44,205 warrants to purchase shares of common
stock. |
(2) |
Reflects
87,108 shares of common stock and 87,108 warrants to purchase shares of
common stock. |
(3) |
Reflects
174,216 shares of common stock and 174,216 warrants to purchase shares of
common stock. |
(4) |
Reflects
696,864 shares of common stock and 696,864 warrants to purchase shares of
common stock. |
(5) |
Reflects
355,528 shares of common stock, 413,441 warrants to purchase shares of
common stock and 91,567 options exercisable for shares of common
stock. |
(5)(a) |
Reflects
355,528 shares of common stock and 355,528 warrants to purchase shares of
common stock |
(5)(b) |
Carmel
Ventures, Inc. has performed consulting services for us and is owned by
Roni Appel, our chief financial officer, director and principal
shareholder. |
(6) |
Reflects
52,833 shares of common stock and 52.883 warrants to purchase shares of
common stock. |
(7) |
Reflects
87,297 shares of common stock and 109,074 warrants to purchase shares of
common stock. |
(7)(a) |
Reflects
87,297 shares of common stock and 87,297 warrants to purchase shares of
common stock. |
(8) |
Reflects
271,260 shares of common stock and 219,973 warrants to purchase shares of
common stock. |
(8)(a) |
Reflects
271,260 shares of common stock and 211,063 warrants to purchase shares of
common stock. |
(9) |
Reflects
522,648 shares of common stock and 522,648 warrants to purchase shares of
common stock. |
(10) |
Reflects
244,933 shares of common stock and 115,320 warrants to purchase shares of
common stock. |
(10)(a) |
Reflects
266,933.shares of common stock and 93,046 warrants to purchase shares of
common stock. |
(11) |
Reflects
348, 432 shares of common stock and 348,432 warrants to purchase shares of
common stock. |
(12) |
Reflects
1,742,160 shares of common stock and 1,742,160 warrants to purchase shares
of common stock. |
(13) |
Reflects
106,272 shares of common stock and 248,827 warrants to purchase shares of
common stock. |
(13)(a) |
Reflects
106,272 shares of common stock and 106,272 warrants to purchase shares of
common stock. |
(14) |
Reflects
2,585,094 shares of common stock and 45,141 warrants to purchase shares of
common stock. |
(14)(a) |
Reflects
2,621,325 shares of common stock and 36,231 warrants to purchase shares of
common stock. |
(14)(b) |
The
general partner of Flamm Family Partners is Scott Flamm a director and
principal shareholder. |
(15) |
Reflects
35,511 shares of common stock and 44,421 warrants to purchase shares of
common stock. |
(15)(a) |
Reflects
35,511 shares of common stock and 35,511 warrants to purchase shares of
common stock. |
(16) |
Reflects
261,324 shares of common stock and 261,324 warrants to purchase shares of
common stock. |
(17) |
Reflects
70,093 shares of common stock and 87,515 warrants to purchase shares of
common stock. |
(17)(a) |
Reflects
70,093 shares of common stock and 70,093 warrants to purchase shares of
common stock. |
(18) |
Reflects
295,766 shares of common stock and 1,172,767 options to purchase shares of
common stock and 368,815 shares of common stock issuable upon exercise of
warrants. |
(18)(a) |
Reflects
295,766 shares of common stock and 295,766 warrants to purchase shares of
common stock. |
(18)(b) |
Mr.
Derbin is one of our directors and the chief executive
officer. |
(19) |
Reflects
56,349 options to purchase shares of common stock, 36,551 warrants to
purchase shares of common stock and 2,820,576 shares of common stock but
does not reflect 147,716 warrants to purchase shares of common stock
because such warrants are not currently exercisable within the next 60
days. |
(19)(a) |
Reflects
2,820,576 shares of common stock and 14,7716 warrants to purchase shares
of common stock. |
(19)(b |
Dr.
Patton is one of our directors. |
(20) |
Reflects
17,430 shares of common stock and 21,785 warrants to purchase shares of
common stock. |
(20)(a) |
Reflects
17,430 shares of common stock and 17,430 warrants to purchase shares of
common stock. |
(21) |
Reflects
35,865 shares of common stock and 44,775 warrants to purchase shares of
common stock. |
(21)(a) |
Reflects
35,865 shares of common stock and 35,865 warrants to purchase shares of
common stock. |
(22) |
Reflects
89,663 shares of common stock and 111,937 warrants to purchase shares of
common stock. |
(22)(a) |
Reflects
89,663 shares of common stock and 89,663 warrants to purchase shares of
common stock. |
(23) |
Reflects
98,664 shares of common stock and 98,664 warrants to purchase shares of
common stock. |
(24) |
Reflects
126,658 shares of common stock and 157,842 warrants to purchase shares of
common stock. |
(24)(a) |
Reflects
126,658 shares of common stock and 126,658 warrants to purchase shares of
common stock. |
(25) |
Reflects
35,180 shares of common stock and 43,981 warrants to purchase shares of
common stock. |
(25)(a) |
Reflects
35,180 shares of common stock and 35,180 warrants to purchase shares of
common stock. |
(26) |
Reflects
35,401 shares of common stock and 44,311 warrants to purchase shares of
common stock. |
(26)(a) |
Reflects
35,401 shares of common stock and 35,401 warrants to purchase shares of
common stock. |
(27) |
Reflects
2,522,164 shares of common stock and 73,029 warrants to purchase shares of
common stock.. |
(27)(a) |
Reflects
2,522,164 shares of common stock and 58,580 warrants to purchase shares of
common stock |
(27)(b) |
Mr.
Appel is one of our directors and our chief financial officer and owner of
Carmel Ventures, Inc., one of our stockholders and is employed by LVEP
Management, LLC one of our consultants. |
(28) |
Reflects
125,772 shares of common stock, 156,956 warrants to purchase shares of
common stock and 91,567 options. |
(28)(a) |
Reflects
125,772 shares of common stock and 125,772 warrants to purchase shares of
common stock. |
(28)(b) |
Mr.
Flamm is one of our directors and also the general partner of Flamm Family
Partners, one of our stockholders and is the beneficial owner of LVEP
Management, LLC one of our consultants. |
(29) |
Reflects
179,290 shares of common stock, 82,763 options and 112,823 warrants to
purchase shares of common stock. |
(29)(a) |
Reflects
179,290 shares of common stock and 90,549 warrants to purchase shares of
common stock. |
(29)(b) |
Mr.
McKearn is one of our directors. |
(30) |
Refelcts
704,365 shares of common stock and 169,048 options to purchase shares of
common stock. |
(31) |
Reflects
1,094,020 shares of common stock warrants to purchase 672,539 shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the
selling Stockholder’s employer, Sunrise Securities Corp. as
Placement Agent. |
(32) |
Reflects
119,466 shares of common stock and 74,727 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(33) |
Reflects
97,561 shares of common stock and 285,211 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of Sunrise Securities Corp. as Placement
Agent. |
(34) |
Reflects
2,070 shares of common stock and 2,070 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of Sunrise Securities Corp. as Placement
Agent. Dr.
Filer is a consultant to Sunrise Securities
Corp. |
(35) |
Reflects
1,124,253 shares of common stock owned by Mr. Low and warrants to purchase
761,971 shares of common stock owned by Mr. Low, all of which securities
were received as compensation in the ordinary course of selling
Stockholder’s employer, business of Sunrise Capital as Placement
Agent. |
(36) |
Reflects
80,488 shares of common stock and 73,170 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(37) |
Reflects
383,275 shares of common stock and 348,432 warrants to purchase shares of
common stock. Nathan Low is the sole director and stockholder, with 100%
beneficial ownership and voting and disposition rights. |
(37)(a) |
Our
placement agent in connection with the Private Placement discussed in this
prospectus. |
(38) |
Reflects
160,976 shares of common stock and 146,341 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(38)(a) |
Sunrise
Foundation Trust is a charitable trust of which Nathan Low, owner of
Sunrise Securities Corp., is a trustee. |
(39) |
Reflects
60,000 warrants to purchase shares of common stock. |
(39)(a) |
Reitler
Brown Holdings, LLC is an affiliate of our legal counsel in connection
with this prospectus. |
(40) |
Reflects
3,832,753 shares of common stock and warrant to purchase 3,832,753 shares
of common stock. |
(41) |
We
license our intellectual property from Penn through an exclusive
license. |
(32) |
Reflects
119,466 shares of common stock and 74,727 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(33) |
Reflects
97,561 shares of common stock and 285,211 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of Sunrise Securities Corp. as Placement
Agent. |
(34) |
Reflects
2,070 shares of common stock and 2,070 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of Sunrise Securities Corp. as Placement
Agent. Dr.
Filer is a consultant to Sunrise Securities
Corp. |
(35) |
Reflects
1,124,253 shares of common stock owned by Mr. Low and warrants to purchase
761,971 shares of common stock owned by Mr. Low, all of which securities
were received as compensation in the ordinary course of business of
Sunrise Capital as Placement Agent. |
(36) |
Reflects
80,488 shares of common stock and 73,170 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(37) |
Reflects
383,275 shares of common stock and 348,432 warrants to purchase shares of
common stock. Nathan Low is the sole director and stockholder, with 100%
beneficial ownership and voting and disposition rights. |
(37)(a) |
Our
placement agent in connection with the Private Placement discussed in this
prospectus. |
(38) |
Reflects
160,976 shares of common stock and 146,341 warrants to purchase shares of
common stock, all of which securities were received as compensation in the
ordinary course of business of the selling Stockholder’s employer, Sunrise
Securities Corp. as Placement Agent. |
(38)(a) |
Sunrise
Foundation Trust is a charitable trust of which Nathan Low, owner of
Sunrise Securities Corp., is a trustee. |
(39) |
Reflects
60,000 warrants to purchase shares of common stock. |
(39)(a) |
Reitler
Brown Holdings, LLC is an affiliate of our legal counsel in connection
with this prospectus. |
(40) |
Reflects
3,832,753 shares of common stock and warrant to purchase 3,832,753 shares
of common stock. |
(41) |
We
license our intellectual property from Penn through an exclusive
license. |
· |
1.0%
of the
number of
shares
of common stock outstanding,
which is approximately 366,900
shares of common stock; or |
· |
the
average
weekly trading volume of the
shares
of common stock during
the four calendar weeks preceding the filing of a notice on Form 144 in
connection with the sale. |
· |
who
is
not considered to have been one of our affiliates at any time during the
90 days preceding a sale; and |
· |
who
has
beneficially owned the shares proposed to be sold for at least two years,
including the holding period of any prior owner other than an
affiliate, |
· |
by
persons
other than affiliates subject only to the manner of sale provisions of
Rule
144;
and |
· |
by
affiliates
under Rule
144
without compliance with its one year minimum holding period requirement.
|
· |
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits Investors; |
· |
block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction; |
· |
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account; |
· |
an
exchange distribution in accordance with the rules of the applicable
exchange; |
· |
privately
negotiated transactions; |
· |
short
sales (other than short sales established prior to the effectiveness of
the Registration Statement to which this Prospectus is a part)
|
· |
broker-dealers
may agree with the Selling Stockholders to sell a specified number of such
shares at a stipulated price per share; |
· |
a
combination of any such methods of sale;
and |
· |
any
other method permitted pursuant to applicable
law. |
Report
of Independent Registered Public Accounting Firm |
F-2 |
Financial
Statements: |
|
Balance
Sheet |
F-3 |
Statement
of Operations |
F-4 |
Statement
of Shareholders' Equity (Deficiency) |
F-5 |
Statement
of Cash Flows |
F-7 |
Notes
to Financial Statements |
F-8
- F-20 |
ADVAXIS,
INC. |
|||||||||||||
(a
development stage company) |
|||||||||||||
BALANCE
SHEET |
|||||||||||||
|
|
|
|
||||||||||
December 31, |
October
31, |
January 31, | |||||||||||
2002
|
2003
|
2004 |
2005 |
||||||||||
(unaudited) |
|||||||||||||
ASSETS |
|||||||||||||
Current
Asset - cash |
$ |
204,382 |
$ |
47,160 |
$
|
32,279
|
$ |
3,217,430 |
|||||
Intangible
Assets |
277,243
|
469,804
|
666,447 |
||||||||||
Other
Assets |
2,450 |
||||||||||||
Total
Assets |
$ |
204,382 |
$ |
324,403 |
$
|
502,083
|
$ |
3,886,327 |
|||||
LIABILITIES
AND SHAREHOLDERS' EQUITY (DEFICIENCY) |
|||||||||||||
Current
Liabilities: |
|||||||||||||
Accounts
payable |
$ |
85,825 |
$ |
1,018,936 |
$
|
823,152
|
$ |
435,280 |
|||||
Notes
payable, current portion |
25,408
|
$
|
605,190 |
258,237 |
|||||||||
Total
current liabilities |
85,825
|
1,044,344
|
1,428,342 |
693,517 |
|||||||||
Notes
Payable, net of current portion |
40,000
|
86,794
|
413,237 |
230,000 |
|||||||||
Total
liabilities |
125,825
|
1,131,138
|
1,841,579 |
923,517
|
|||||||||
Commitments
and Contingencies |
|||||||||||||
Shareholders'
Equity (Deficiency): |
|||||||||||||
Common stock - $0.001 par value; authorized 500,000,000 shares,
issued and outstanding 16,350,312 at December 31, 2002 and 2003 and
October 31, 2004 and 36,690,046 shares at January 31,
2005 |
16,350
|
16,350
|
16,350
|
36,690
|
|||||||||
Additional
paid-in capital |
229,143
|
253,596
|
302,795
|
4,830,116
|
|||||||||
Deficit
accumulated during the development stage |
(166,936 |
) |
(1,076,681 |
) |
(1,658,641
|
)
|
(1,903,996 |
) | |||||
|
|
|
|
||||||||||
Shareholders'
equity (deficiency) |
78,557
|
(806,735 |
) |
(1,339,496
|
)
|
2,962,810
|
|||||||
Total
Liabilities and Shareholders' Equity (Deficiency) |
$ |
204,382 |
$ |
324,403 |
$
|
502,083
|
$ |
3,886,327 |
ADVAXIS,
INC. | |||||||||||||||||||
(a
development stage company) | |||||||||||||||||||
STATEMENT
OF
OPERATIONS |
Period
from
March
1,
2002
(inception)
to
December
31, |
Year
ended
December
31, |
Ten
Month Period ended October 31, |
Ten
Month Period ended October 31, |
Period
from
March
1,
2002
(inception)
to
October
31, |
Three-month
period
ended
January
31, |
Three-month
period
ended
January
31, |
Period
from
March
1,
2002
(inception)
to
January
31, |
||||||||||||||||||
2002 |
2003 |
2003 |
2004 |
2004 |
2004 |
2005 |
2005 |
||||||||||||||||||
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
||||||||||||||||||||||
Research
and development expenses |
$ |
50,899 |
$ |
491,508 |
446,324 |
125,942 |
668,349 |
$ |
86,842 |
$ |
218,951 |
$ |
887,300 |
||||||||||||
General
and administrative expenses |
117,003 |
405,568 |
375,403 |
524,368 |
1,046,939 |
45,399 |
26,175 |
1,073,114 |
|||||||||||||||||
Interest
expense |
17,190 |
8,288 |
4,229 |
21,420 |
10,655 |
2,968 |
24,387 |
||||||||||||||||||
Other
income |
966 |
4,521 |
4,106 |
116,463 |
121,950 |
430 |
2,739 |
124,689 |
|||||||||||||||||
Net
loss |
(166,936 |
) |
(909,745 |
) |
(825,907 |
) |
(538,076 |
) |
(1,614,757 |
) |
(142,466 |
) |
(245,355 |
) |
(1,860,112 |
) | |||||||||
Dividends
attributed to preferred stock |
43,884 |
43,884 |
43,884
|
||||||||||||||||||||||
Net
loss applicable to common stock |
$ |
(166,936 |
) |
$ |
(909,745 |
) |
(825,907 |
) |
$ |
(581,960 |
) |
$ |
(1,658,641 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) |
$ |
(1,903,996 |
) | ||
Basic
and diluted net loss per share |
$ |
(0.01 |
) |
$ |
(0.06 |
) |
$ |
(0.05 |
) |
($0.04 |
) |
($0.10 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
$ |
(0.11 |
) | |||
Weighted-average
number of shares, baseic and diluted |
16,350,312 |
16,350,312 |
16,350,312 |
16,350,312 |
16,350,312 |
16,350,323 |
31,271,317 |
17,636,857 |
ADVAXIS,
INC. (a development stage company) | ||||||||||||||||||||||
STATEMENT
OF SHAREHOLDERS' EQUITY (DEFICIENCY) | ||||||||||||||||||||||
Period from March 1, 2002 (inception) to January 31, 2005 |
Preferred
Stock |
Common
Stock |
|||||||||||||||||||||
Number
of Shares Outstanding |
Amount |
Number
of Shares Outstanding |
Amount |
Additional
Paid-in Capital |
Deficit
Accumulated During the Development Stage |
Shareholders'
Equity (Deficiency) |
||||||||||||||||
Preferred
stock issued |
3,418.18
|
$ |
235,000 |
$ |
235,000 |
|||||||||||||||||
Common
stock issued |
40,000
|
$ |
40 |
$ |
(40 |
) |
||||||||||||||||
Options
granted to consultants and professionals |
10,493
|
10,493
|
||||||||||||||||||||
Net
loss |
$ |
(166,936 |
) |
(166,936 |
) | |||||||||||||||||
Retroactive
restatement to reflect recapitalization on November 12,
2004 |
(3,418.18 |
) |
(235,000 |
) |
16,310,312 |
16,310 |
218,690
|
|||||||||||||||
|
||||||||||||||||||||||
Balance
at December 31, 2002 |
-
0 - |
-
0 - |
16,350,312 |
16,350 |
229,143 |
(166,936 |
) |
78,557 |
||||||||||||||
Note
payable converted into preferred stock |
232.27 |
15,969 |
15,969 |
Options
granted to consultants and professionals |
8,484 |
8,484 |
||||||||||||||||||||
Net
loss |
(909,745 |
) |
(909,745 |
) | ||||||||||||||||||
Retroactive
restatement to reflect recapitalization on November 12,
2004 |
(232.27 |
) |
(15,969 |
) |
15,969 |
|||||||||||||||||
|
||||||||||||||||||||||
Balance
at December 31, 2003 |
-
0 - |
-
0 - |
16,350,312
|
16,350 |
253,596
|
(1,076,681 |
) |
(806,735 |
) | |||||||||||||
Stock
dividend on preferred stock |
638.31
|
43,884
|
(43,884 |
) |
||||||||||||||||||
Net
loss |
(538,076 |
) |
(538,076 |
) | ||||||||||||||||||
Options
granted to consultants and professionals |
5,315 |
5,315
|
||||||||||||||||||||
Retroactive
restatement to reflect recapitalization on November 12,
2004 |
(638.31 |
) |
(43,884 |
) |
43,884 | |||||||||||||||||
Balance
at October 31, 2004 |
- 0
- |
- 0
- |
16,350,312 |
16,350 |
302,795 |
(1,658,641 |
) |
(1,339,496 |
) | |||||||||||||
(Unaudited): |
||||||||||||||||||||||
Common
Stock issued to Placement Agent on recapitalization |
752,600 |
753 |
(753 |
) |
||||||||||||||||||
Options
granted to consultants and professionals |
||||||||||||||||||||||
Conversion
of Note payable to Common Stock |
2,136,441 |
2,136 |
611,022 |
613,158 |
||||||||||||||||||
Issance
of Common Stock for cash, net of shares to Placement Agent |
17,450,693 |
17,451 |
4,335,549 |
4,353,000 |
||||||||||||||||||
Issuance
Costs |
(329,673 |
) |
(329,673 |
) | ||||||||||||||||||
Net
loss |
(245,355 |
) |
(245,355 |
) |
Restatement
to reflect recapitalization on November 12, 2004 including cash paid of
$44,940 |
(88,824
|
) |
(88,824 |
) | ||||||||||||||||||
Balance
at January 31, 2005 |
$ |
-
0 - |
$ |
-
0 - |
36,690,046
|
$ |
36,690 |
$ |
4,830,116 |
$ |
(1,903,996 |
) |
$ |
2,962,810 |
| |||||||
ADVAXIS,
INC. (a development stage company) | |||||||||||||||||||
STATEMENT
OF CASH FLOWS |
Period
from March 1, 2002 (inception) to December 31, |
|
Year
ended December 31, |
|
Tenth
Month Period ended October 31 |
|
Tenth
Month Period ended October 31 |
|
Period
from March 1, 2002 (inception) to October 31, |
|
Three-month
period ended January 31, |
|
Three-month
period ended January 31, |
|
Period
from March 1, 2002 (inception) to January 31, |
| ||||||||||
|
|
|
2002 |
|
|
2003 |
|
|
2003 |
|
|
2004 |
|
|
2004 |
|
|
2004 |
|
|
2005 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(unaudited) |
|
Cash
flows from operating activities: |
|||||||||||||||||||||||||
Net
loss |
$ |
(166,936 |
) |
$ | (909,745 | ) |
(825,907 |
) |
(538,076 |
) |
(1,614,757 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) |
$ |
(1,860,112 |
) | ||||
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities: |
|||||||||||||||||||||||||
Value
assigned to options given as payment to consultants and
professionals |
10,493 |
8,484 |
5,315 |
24,292 |
8,484 |
24,292 |
|||||||||||||||||||
Amortization
expense |
3,171 |
15,818 |
18,989 |
800 |
6,817 |
25,806 |
|||||||||||||||||||
Accrued
interest on notes payable |
|
|
|
7,968 |
7,968 |
||||||||||||||||||||
Increase
in Other Assets |
(2,450 |
) |
(2,450 |
) | |||||||||||||||||||||
Increase
(decrease) in accounts payable |
85,825 |
933,111 |
840,037 |
80,307 |
1,099,243 |
102,910 |
(356,756 |
) |
742,487 |
||||||||||||||||
Net
cash provided by (used in) operating activities |
(70,618 |
) |
35,021 |
14,130 |
(436,636 |
) |
(472,233 |
) |
(30,272 |
) |
(589,776 |
) |
(1,062,009 |
) |
CASH
FLOWS USED IN INVESTING ACTIVITIES: |
|||||||||||||||||||||||||
Cash
paid on acquisition of Great Expectations |
(44,940 |
) |
(44,940 |
) | |||||||||||||||||||||
Cost
of Intangible Assets |
(277,243 |
) |
(217,133 |
) |
(124,469 |
) |
(401,712 |
) |
(30,228 |
) |
(203,460 |
) |
(605,172 |
) | |||||||||||
Net
cash used in Investing Activities |
(277,243 |
) |
(217,133 |
) |
(124,469 |
) |
(401,712 |
) |
(30,228 |
) |
(248,400 |
) |
(650,112 |
) | |||||||||||
Cash
flows from financing activities: |
|||||||||||||||||||||||||
Proceeds
from notes payable |
40,000 |
85,000 |
|
|
546,224 |
671,224 |
87,203 |
671,224 |
|||||||||||||||||
Net
proceeds on issuance of preferred stock |
235,000 |
|
235,000 |
235,000 |
|||||||||||||||||||||
Net
Proceeds on Issuance of Common Stock |
4,023,327 |
4,023,327 |
|||||||||||||||||||||||
Cash
provided by financing activities |
275,000 |
85,000 |
|
546,224 |
906,224 |
87,203 |
4,023,327 |
4,929,551 |
|||||||||||||||||
Net
increase (decrease) in cash |
204,382 |
(157,222 |
) |
(203,003 |
) |
(14,881 |
) |
32,279 |
26,703 |
3,185,151 |
3,217,430 |
||||||||||||||
Cash
at beginning of period |
204,382 |
204,382 |
47,160 |
1,379 |
32,279 |
||||||||||||||||||||
|
Cash
at end of period |
$ |
204,382 |
$ |
47,160 |
$ |
1,379 |
$ |
32,279 |
$ |
32,279 |
$ |
28,082 |
$ |
3,217,430 |
$ |
3,217,430 |
Period
from March 1, 2002 (inception) to December 31,
2002 |
Year
ended December 31, 2003 |
Tenth
Month Period ended October 31, 2003 |
Tenth
Month Period ended October 31, 2004 |
Period
from March 1, 2002 (inception) to December 31,
2003 |
Three
months ended January 31, 2005 |
Three
months ended January 31, 2004 |
Period
from March 1, 2002 (Inception) January 31, 2005 |
||||||||||||||||||
SUPPLEMENTAL
SCHEDULE OF NONCASH INVESTING AND FINANCING ACTIVITIES: |
|||||||||||||||||||||||||
Common
Stock issued to founders |
$ |
40 |
$ |
40 |
$ |
40 |
|||||||||||||||||||
Notes
Payable and Accrued Interest Converted to Preferred Stock |
$ |
15,969 |
$ |
15,969 |
$ |
15,969 |
$ |
15,969 |
|||||||||||||||||
Stock
Dividend on Preferred Stock |
$ |
43,884 |
$ |
43,884 |
$ |
43,884 |
|||||||||||||||||||
Notes
Payable and Accrued Interest Converted to Common |
$ |
631,158 |
$ |
613,158 |
|||||||||||||||||||||
Intangible
Assets Acquired with Notes Payable |
$ |
360,000 |
$ |
360,000 |
$ |
360,000 |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
1.
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: |
Advaxis,
Inc. (the "Company") was incorporated in 2002 and is a biotechnology
company researching and developing new cancer-fighting
techniques.
The
Company is in the development stage and its operations are subject to all
of the risks inherent in an emerging business enterprise. The accompanying
financial statements have been prepared assuming the Company will continue
as a going concern. As shown in the financial statements, the Company has
incurred losses from operations, and has a working capital deficit of
$971,776 and $1,396,063, and a shareholders' deficiency of $806,735 , and
$1,339,496 at December 31, 2003 and October 31, 2004 , respectively.
Management has raised (see Note 8) and will continue to raise additional
funds through equity and is working to develop technologies that will
generate revenue that will allow the Company to continue as a going
concern. These financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
In
accordance with Securities and Exchange Commission (SEC) Staff Accounting
Bulletin (SAB) No. 104, revenue from license fees and grants is recognized
when the following criteria are met; persuasive evidence of an arrangement
exists, services have been rendered, the contract price is fixed or
determinable, and collectibility is reasonably assured. In licensing
arrangements, delivery does not occur for revenue recognition purposes
until the license term begins. Nonrefundable upfront fees received in
exchange for products delivered or services performed that do not
represent the culmination of a separate earnings process will be deferred
and recognized over the term of the agreement.
For
revenue contracts that contain multiple elements, the Company will
determine whether the contract includes multiple units of accounting in
accordance with EITF No. 00-21, Revenue
Arrangements with Multiple Deliverables.
Under that guidance, revenue arrangements with multiple deliverables are
divided into separate units of accounting if the delivered item has value
to the customer on a standalone basis and there is objective and reliable
evidence of the fair value of the undelivered item.
The
Company maintains its cash in bank deposit accounts which, at times, may
exceed federally insured limits.
Intangible
assets, which consist primarily of legal costs in obtaining trademarks and
patents, are being amortized on a straight-line basis over 15 and 17
years, respectively.
The
Company reviews long-lived assets for impairment whenever events or
changes in circumstances indicate that the carrying amount of an asset may
not be recoverable. An asset is considered to be impaired when the sum of
the undiscounted future net cash flows expected to result from the use of
the asset and its eventual disposition exceeds its carrying amount. The
amount of impairment loss, if any, is measured as the difference between
the net book value of the asset and its estimated fair
value. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
Basic
loss per share is computed by dividing net loss by the weighted-average
number of shares of common stock outstanding during the periods. Diluted
earnings per share gives effect to dilutive options, warrants and other
potential common stock outstanding during the period. Potential common
stock has not been included in the computation of diluted loss per share,
as the effect would be antidilutive.
Deferred
income taxes are provided for the differences between the bases of assets
and liabilities for financial reporting and income tax purposes. A
valuation allowance is established when necessary to reduce deferred tax
assets to the amount expected to be realized.
The
preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires the
use of estimates by management. Actual results could differ from these
estimates.
The
estimated fair value of the notes payable approximates the carrying amount
based on the rates available to the Company for similar debt.
Accounts
payable consists entirely of trade accounts payable.
Research
and development costs are charged to expense as incurred.
Management
does not believe that any recently issued, but not yet effective,
accounting standards if currently adopted would have a material effect on
the accompanying financial
statements. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
The
Company has elected to apply APB Opinion No. 25 and related
interpretations in accounting for its stock options granted to employees
and has adopted the disclosure-only provisions of SFAS No. 123. Had the
Company elected to recognize compensation cost based on the fair value of
the options granted at the grant date as prescribed by SFAS No. 123, the
Company's net loss would have been as
follows: |
March
1, 2002 (date of inception) to December
31, 2002 |
Year
ended
December
31, 2003 |
10
months ended October 31, 2003 |
10
months ended October 31, 2004 |
3
months ended
January
31
2004 |
3
months ended
January
31,
2005 |
||||||||||||||
Net
Loss as reported |
$ |
(166,936 |
) |
$ |
(909,745 |
) |
$ |
(825,907 |
) |
$ |
(538,076 |
) |
$ |
(142,466 |
) |
$ |
(245,355 |
) | |
Deduct
stock option compensation expense determined under fair value based
method |
(8,566 |
) |
(32,923 |
) |
$ |
(30,199 |
) |
$ |
(70,019 |
) |
(22,612 |
) |
(18,573 |
) | |||||
Adjusted
Net Loss |
$ |
(175,502 |
) |
$ |
(942,668 |
) |
$ |
(856,106 |
) |
$ |
(608,095 |
) |
$ |
(165,078 |
) |
$ |
(263,928 |
) | |
Net
Loss per share as reported |
$ |
(0.01 |
) |
$ |
(0.06 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) | |
Net
Loss per share pro forma |
$ |
(0.01 |
) |
$ |
(0.06 |
) |
$ |
(0.05 |
) |
$ |
(0.04 |
) |
$ |
(0.01 |
) |
$ |
(0.01 |
) |
The
Company accounts for nonemployee stock-based awards in which goods or
services are the consideration received for the equity instruments issued
based on the fair value of the equity instruments in accordance with the
guidance provided in the consensus opinion of the Emerging Issues Task
Force ("EITF") Issue 96-18, Accounting
for Equity Instruments that Are Issued to Other than Employees for
Acquiring, or in Conjunction With Selling Goods or
Services. | |
The
accompanying unaudited interim financial statements have been prepared in
accordance with generally accepted accounting principles for interim
financial information and the requirements of item 310(b) of Regulation
S-B. Accordingly, certain information and footnote disclosures normally
included in financial statements prepared in accordance with generally
accepted accounting principles have been condensed or omitted pursuant to
the rules and regulations of the Securities and Exchange Commission. The
results of operations for the three-month period ended January 31, 2005
are not necessarily indicative of the results of operations expected for
the year ended October 31, 2005. | |
In
the opinion of management, the accompanying unaudited interim financial
statements for the nine-month periods ended September 30, 2004 and 2003
include all adjustments (consisting only of those of a normal recurring
nature) necessary for a fair statement of the results of the interim
period. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
2.
INTANGIBLE ASSETS: |
Intangible
assets consist of the following:
|
|
December
31, 2003 |
|
|
October
31, 2004 |
||
Trademarks |
$ |
8,243 |
$ |
8,243 |
||
Patents |
117,377 |
|||||
License |
|
269,000 |
360,000 |
|||
Less:Accumulated
Amortization |
(15,818 |
) | ||||
$ |
277,243 |
$ |
469,804 |
|||
During the ten-month period ended October 31, 2004, the Company renegotiated certain payables with its attorney which reduced intangible assets by $98,090. | ||||||
Estimated amortization expense is as follows: | ||||||
Year ending October 31, |
2005 |
$ |
24,281 |
||
2006 |
24,281 |
|||
2007 |
24,281 |
|||
2008 |
24,281 |
|||
2009 |
24,281 |
|||
During
the three-month period ended January 31, 2005, the Company acquired
$203,460 of new patents. Amortization expense during the period amounted
to $6,817. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
3. |
NOTES
PAYABLE: |
|
||||||||||
|
|
|
|
|
Notes
payable consist of the following: |
||||||||||
December
31, |
October
31 |
|||||||||
|
|
|
2003 |
|
|
2002 |
|
|
2004 |
|
Note
payable with interest at 6% per annum, due on December 31, 2005. The
amount is mandatorily convertible at the time of the closing of the
Company's contemplated $2,000,000 equity financing into the same class of
shares issued at the equity financing at a conversion price per share
equivalent to the price per share in the equity financing. Upon closing of
an equity financing which is less than $2,000,000, the holder has the
right to convert, at the holder's option, into the same class of shares
issued at the equity financing at a conversion price per share equivalent
to the price per share in the equity financing. |
$ |
10,060 |
|
|
$ |
605,190 |
||||
Note
payable with interest at 8% per annum, due on November 10,
2008. |
10,112 |
|
10,647 |
|||||||
Note
payable with interest at 8% per annum, due on December 17,
2008. |
40,122 |
|
42,590 | |||||||
Note
payable with interest at 6% per annum, due on December 31, 2004. The
amount is mandatorily convertible at the time of the closing of the
Company's contemplated $2,000,000 equity financing into the same class of
shares issued at the equity financing at a conversion price per share
equivalent to the price per share in the equity financing. Upon closing of
an equity financing which is less than $2,000,000, the holder has the
right to convert, at the holder's option, into the same class of shares
issued at the equity financing at a conversion price per share equivalent
to the price per share in the equity financing. |
25,408 |
|||||||||
Notes
payable with no interest, due on December 15, 2006. |
|
130,000 |
||||||||
Notes
payable with no interest, due on December 15, 2007. |
|
230,000 |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
(continued) |
||||||||||
December
31, |
October
31 |
|||||||||
2003 |
2002 |
2004 |
||||||||
Note
payable with interest at 6% per annum, due on June 30, 2005. The amount is
convertible at the holder's option into Series A convertible preferred
stock at a price per share of $68.75. |
$ |
26,500 |
$ |
25,000 |
||||||
Note
payable with interest at 6% per annum, due and payable on June 30, 2005.
The amount is convertible at the holder's option into Series A convertible
preferred stock at a price per share of $68.75. The full amount of this
note plus accrued interest of $969 was converted into 232.27 shares of
Series A preferred stock on September 22, 2003. |
|
15,000 |
||||||||
112,202
|
40,000
|
1,018,427
|
||||||||
Less
current portion |
25,408 |
605,190 | ||||||||
$ |
86,794 |
$ |
40,000 |
$ |
413,237 |
|||||
Aggregate
maturities of notes payable at October 31, 2004 are as
follows: |
||||||||||
Year
ending December 31,
|
||||||||||
|
||||||||||
2005 |
605,190 |
|||||||||
2006 |
130,000 |
|||||||||
2007 |
230,000 |
|||||||||
2008 |
53,237 |
|||||||||
$ |
1,018,427 |
|||||||||
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
4. |
STOCK
OPTIONS: |
The Company has adopted the Advaxis, Inc. 2002 Stock Option Plan (the "Plan"), which allows for grants up to 8,000 shares of the Company's common stock. The Plan shall be administered and interpreted by the Company's board of directors. |
Stock
option activity during the periods indicated is as
follows: |
|
Weighted- |
||||||
|
|
average |
|||||
|
Options |
Exercise |
|||||
|
|
Granted |
|
Price |
|||
Granted
from the period March 1, 2002 (inception) to December 31,
2002 |
4,351 |
$ |
73.63 |
||||
Outstanding
at December 31, 2002 |
4,351 |
73.63 |
|||||
Granted |
1,777 |
97.47 |
|||||
Outstanding
at December 31, 2003 |
6,464 |
$ |
78.91 |
||||
Granted |
350 |
$ |
117.32 |
||||
Forfeited |
(750 |
) |
$ |
68.75 |
|||
Outstanding
at October 31, 2004 |
6,064 |
$ |
80.95 |
||||
Vested
and exercisable at October 31, 2004 |
3,917 |
$ |
87.63 |
||||
|
|||||||
At
October 31, 2004, the weighted exercise prices and weighted-average
remaining contractual life of outstanding options were $80.95 and 7.70
years, respectively. |
|||||||
The
fair value of each option is estimated on the date of grant using the
Black-Scholes option-pricing model with the following assumptions used for
grants in 2004, 2003 and 2002: dividend yield of 0%; average risk-free
interest rates of 6%; volatility of 0%; and an expected life of 10 years
in each year. |
|||||||
Also
under the Plan, the Company has granted 3,430 options to purchase the
Company's common stock that are being accounted for under variable plan
accounting because these options have an exercise price that is subject to
a one-time price adjustment following the next round of equity financing.
Accordingly, each period, increases in the stock price of the Company will
result in a charge to operations for the increase in the Company's stock
price multiplied by the number of these options still outstanding.
However, there has been no fluctuation in the Company's stock price from
inception to December 31, 2003 and, as such, no charge has been taken on
the accompanying statement of operations. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
On
November 12, 2004, in connection with the recapitalization (see Note 8),
the above options were canceled, and employees and consultants were
granted options of Great Expectations. The pro forma disclosures in Note 1
are presented for the options outstanding prior to the recapitalization.
The cancellation and replacement had no accounting consequence since the
aggregate intrinsic value of the options immediately after the
cancellation and replacement was not greater than the aggregate intrinsic
value immediately before the cancellation and replacement, and the ratio
of the exercise price per share to the fair value per share was not
reduced. Additionally, the original options were not modified to
accelerate vesting or extend the life of the new
options. |
5. |
SHAREHOLDERS'
EQUITY: |
Prior
to the recapitalization (see Note 8), the Company had convertible
preferred stock with $.001 par value and 50,000 shares authorized. 6,000
of those shares were designated as Series A and 3,418.18, 3,650.45, and
3.640.45 were issued and outstanding at December 31, 2002, December 31,
2003 and October 31, 2004, respectively. The Company also had 100,000
shares authorized of $.001
par value common stock with 40,000 shares issued and outstanding at
December 31, 2002 and 2003, and at October 31,
2004. |
|
The
preferred stock and common stock amounts were retroactively restated to
reflect the effects of the recapitalization on November 12, 2004 (see Note
8). |
6. |
COMMITMENTS
AND CONTINGENCIES: |
Pursuant
to multiple consulting agreements and a licensing agreement, the Company
is contingently liable for the following: |
The
Company is obligated to pay $35,500 to two consultants upon receiving
financing of $1,000,000 or greater. |
The
Company is obligated to pay $20,000 to two consultants upon receiving
financing of $500,000 or greater and an additional $20,000 upon receiving
financing of $2,000,000 or greater. |
The
Company is obligated to pay $91,000 to two consultants upon receiving
financing of $4,000,000 or greater. |
Under
a licensing agreement, the Company has agreed to pay $525,000 over a
four-year period as a royalty after the first commercial sale of a product
under the license. The Company is also obligated to pay annual license
maintenance fees ranging from $25,000 to $125,000 per year after the first
commercial sale of a product under the license. The Company is also
obligated to pay up to $660,000 to the licensor upon receiving financing.
The amount due is contingent upon the size of the
financing. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
As
of October 31, 2004, the Company has an employment agreement with a key
executive through December 31, 2004. The agreement shall be automatically
renewed for one-year periods unless the Company or the key executive gives
the other party written consent of its intent not to renew at least 30
days prior to the end of the term of the contract. The agreement provides
for an annual base salary of $150,000, which will be adjusted to $225,000
to $250,000 per annum once the Company closes on its next round of equity
financing. |
The Company is also obligated under two employment agreements to pay approximately $220,000 per annum upon the closing of the next round of equity financing. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
7. |
INCOME
TAXES: |
The
Company has a net operating loss carryforward of approximately $1,800,000
at October 31, 2004 available to offset taxable income through
2023. |
The
tax effects of loss carryforwards give rise to a deferred tax asset and a
related valuation allowance as follows: |
||||||
December
31, 2003 |
October
31, 2004 |
|||||
Net
operating losses |
$ |
640,000 |
$ |
720,000 |
||
Less
valuation allowance |
(640,000 |
) |
(720,000 |
) | ||
Deferred
tax asset |
$ |
- 0
- |
$ |
- 0
- |
||
The
difference between income taxes computed at the statutory federal rate of
34% and the provision for income taxes relates to the
following: |
Period
from |
||||||||||||||||
1-Mar-02 |
Ten-month |
three-month |
||||||||||||||
(inception)
to |
Year
ended |
period
ended |
period
ended |
|||||||||||||
December
31, |
December
31, |
October
31, |
January
31, |
|||||||||||||
2002 |
2003 |
2004 |
2004 |
2005 |
||||||||||||
Provision
at federal statutory rate |
34 |
% |
34 |
% |
34 |
% |
34 |
% |
34 |
% | ||||||
Valuation
allowance |
(34 |
) |
(34 |
) |
(34 |
) |
(34 |
) |
(34 |
) | ||||||
-0- |
% |
-0- |
% |
-0- |
% |
-0- |
% |
-0- |
% |
8. |
SUBSEQUENT
EVENTS: |
On
November 12, 2004, Great Expectations and Associates, Inc. ("Great
Expectations") acquired the Company through a share exchange and
reorganization (the "Recapitalization"), pursuant to which the Company
became a wholly owned subsidiary of Great Expectations. Great Expectations
acquired (i) all of the issued and outstanding shares of common stock of
the Company and the Series A preferred stock of the Company in exchange
for an aggregate of 15,597,723 shares of authorized, but theretofore
unissued, shares of common stock, no par value, of Great Expectations;
(ii) all of the issued and outstanding warrants to purchase the Company's
common stock, in exchange for warrants to purchase 584,885 shares of Great
Expectations; and (iii) all of the issued and outstanding options to
purchase the Company's common stock in exchange for an aggregate of
2,381,525 options to purchase common stock of Great Expectations,
constituting approximately 96% of the common stock of Great Expectations
prior to the issuance of shares of common stock of Great Expectations in
the private placement described below. Prior to the closing of the
Recapitalization, Great Expectations performed a 200-for-1 reverse stock
split, thus reducing the issued and outstanding shares of common stock of
Great Expectations from 150,520,000 shares to 752,600 shares.
Additionally, 752,600 shares of common stock of Great Expectations were
issued to the financial advisor in connection with the Recapitalization.
Pursuant to the Recapitalization, there are 17,102,923 common shares
outstanding in Great Expectations. |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
As
a result of the transaction, the former shareholders of Advaxis are the
controlling shareholders of the Company. Additionally, prior to the
transaction, Great Expectations had no substantial assets. Accordingly,
the transaction is treated as a recapitalization of a public shell, rather
than a business combination. The historical financial statements of
Advaxis are now the historical financial statements of the Company.
Historical shareholders' equity (deficiency) of Advaxis has been restated
to reflect the recapitalization, and include the shares received in the
transaction. |
Pro
forma information has not been presented since the transaction is not a
business combination. |
November
12, 2004, the Company completed an initial closing of a private placement
offering (the “Private Placement”), whereby it sold an aggregate of $2.925
million worth
of units to accredited investors. Each unit was sold for $25,000 (the
“Unit Price”) and consisted of (a) 87,108 shares of common stock and (b) a
warrant to purchase, at any time prior to the fifth anniversary following
the date of issuance of the warrant, to purchase 87,108 shares of common
stock included at a price equal to $0.40 per share of common stock (a
“Unit”). In consideration of the investment, the Company granted to each
investor certain registration rights and anti-dilution rights. Also, in
November 2004, the Company converted approximately $618,000 of aggregate
principal promissory notes and accrued interest outstanding into
Units.
|
On
December 8, 2004, the Company completed a second closing of the Private
Placement, whereby it sold an aggregate of $200,000 of Units to accredited
investors.
|
On
January 4, 2005, the Company completed a third and final closing of the
Private Placement, whereby it sold an aggregate of $128,000 of Units to
accredited investors.
|
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
Pursuant
to the terms of a investment banking agreement, dated March 19, 2004, by
and between the Company and Sunrise Securities, Corp. (the “Placement
Agent”), the Company issued to the Placement Agent and its designees an
aggregate of 2,283,445 shares of common stock and warrants to purchase up
to an aggregate of 2,666,900 shares of common stock. The shares were
issued as part consideration for the services of the Placement Agent, as
placement agent for the Company in the Private Placement. In addition, the
Company paid the Placement Agent a total cash fee of $50,530.
|
On
January 12, 2005, the Company completed a second private placement
offering whereby it sold an aggregate of $1,100,000 of units to a single
investor. As with the Private Placement, each unit issued and sold in this
subsequent private placement was sold at $25,000 per unit and is comprised
of (i) 87,108 shares of common stock, and (ii) a five-year warrant to
purchase 87,108 shares of our common stock at an exercise price of $0.40
per share. Upon the closing of this second private placement offering the
Company issued to the investor 3,832,753 shares of common stock and
warrants to purchase up to an aggregate of 3,832,753 shares of common
stock. |
The
aggregate sale from the four private placements was $4,353,000, which was
netted against transaction costs of $329,673 for net proceeds of
$4,023,327. |
Pursuant
to the Recapitalization and the first closing of the private placement,
there are 2,381,525 options to purchase the Company's common stock
outstanding. These options have a 10-year life and vest ratably over a
four-year period. A summary of the options outstanding are as
follows: |
Options |
Exercise
Price |
|||
1,966,939 |
$ |
0.1952 |
||
14,087 |
$ |
0.2839 |
||
35,639 |
$ |
0.2870 |
||
227,509 |
$ |
0.3549 |
||
137,351 |
$ |
0.4259 |
||
2,381,525 |
Pursuant
to the Recapitalization and the first closing of the private placement,
there are 14,951,292 warrants to purchase the Company's common stock
outstanding. A summary of the warrants outstanding are as
follows: |
ADVAXIS, INC. (a development stage company) | ||||
NOTES TO FINANCIAL STATEMENTS (information related to the ten-month period ended October 31, 2003 and the three-month periods ended January 31, 2005 and 2004 is unaudited) |
Amount |
Exercise
Price |
Expiration |
|||||
2,543,553 |
$ |
0.20 |
2009 |
||||
35,218 |
$ |
0.28 |
2011 |
||||
142,555 |
$ |
0.29 |
2007 |
||||
2,038,328 |
$ |
0.29 |
2009 |
||||
10,191,638 |
$ |
0.40 |
2009 | ||||
14,951,292 |
On
December 20, 2004, the Company entered into an Amended and Restated
Employment Agreement with J. Todd Derbin, its current chief executive
officer and president ("Employment Agreement"). Pursuant to the terms of
the Employment Agreement, Mr. Derbin shall serve as the Company's chief
executive officer and president for a period of one year commencing on
January 1, 2005. The Employment Agreement may be extended, in writing, by
the Company and Mr. Derbin. Mr. Derbin's salary shall be $200,000,
provided that it shall be increased to $225,000 or $250,000 based upon
certain milestones of the Company as set forth in the Employment
Agreement. In addition, Mr. Derbin shall be entitled to bonuses in the
form of equity and/or cash as set forth in the Employment Agreement and he
shall be entitled to receive non-qualified stock options to purchase
common stock of the Company (the "Options"), the amount of which when
added to his existing 1,172,767 options shall equal 5% of the total issued
and outstanding common stock of the Company, as of March 31, 2005.
One-half of the Options shall vest on the grant date and one-half of the
Options shall vest monthly over four years at a rate of 1/48th
per month. The grant of the Options is subject to the Company adopting a
2005 Stock Option Plan, which is subject to stockholder
approval. |
The
Company entered into an employment agreement with Dr. Vafa Shahabi PhD to
become Head of Director of Science effective March 1, 2005, terminable on
30 days notice. The compensation is $100,000 per annum with a potential
bonus of $20,000. In addition, Dr. Shahabi will be granted 150,000
options. |
The
Company entered into an employment agreement with Dr. John Rothman, Ph.D
to become Vice President of Clinical Development effective March 7, 2005
for a term of one year ending February 28, 2006 and terminable on 30 days
notice. His compensation is $170,000 per annum, to increase to $180,000
upon the closing of a $15 million equity financing. Upon meeting
incentives to be set by the Company, he will receive a bonus of up to
$45,000. In addition, Dr. Rothman will be granted 360,000 stock
options. |
SEC
registration fee |
$ |
6,628.94* |
||
Printing
and engraving expenses |
$ |
10,000* |
||
Legal
fees and expenses |
$ |
25,000* |
||
Accounting
fees and expenses |
$ |
5,000* |
||
Transfer
agent and registrar’s fees and expenses |
$ |
10,000* |
||
Miscellaneous
expense |
$ |
3,371.06* |
||
Total |
$ |
60,000* |
EXHIBITS | ||
EXHIBIT
NUMBER |
DESCRIPTION
OF EXHIBIT | |
Exhibit
3.1 |
Amended
and Restated Articles of Incorporation. Incorporated by reference to
Exhibit 3.1 to Report on Form 8K filed with the SEC on December 27,
2004. | |
Exhibit
3.2 |
Amended
and Restated Bylaws. Incorporated by reference to | |
Exhibit
3.1 to Report on Form 8K filed with the SEC on December 27,
2004. | ||
Exhibit
4.1 |
Form
of Warrant issued to purchasers. Incorporated by reference to Exhibit 4.1
to Report on Form 8K filed with the SEC on November 18,
2004. | |
Exhibit
4.2 |
Form
of Warrant issued to Placement Agent. Incorporated by reference to Exhibit
4.2 to Report on Form 8K filed with the SEC on November 18,
2004. | |
Exhibit
5.1 |
Opinion
of Frascona, Joiner, Goodman and Greenstein, PC | |
Exhibit
10.1 |
Share
and Exchange Agreement, dated as of August 25, 2004, by and among the
Company, Advaxis and the shareholders of Advaxis. Incorporated by
reference to Exhibit 10.1 to Report on Form 8K filed with the SEC on
November 18, 2004. | |
Exhibit
10.2 |
Form
of Securities Purchase Agreement, by and among the Company and the
purchasers listed as signatories thereto. Incorporated by reference to
Exhibit 10.2 to Report on Form 8K filed with the SEC on November 18,
2004. | |
Exhibit
10.3 |
Form
of Registration Rights Agreement, by and among the Company and the persons
listed as signatories thereto. Incorporated by reference to Exhibit 10.3
to Report on Form 8K filed with the SEC on November 18,
2004. | |
Exhibit
10.4 |
Form
of Standstill Agreement, by and among the Company and persons listed on
Schedule 1 attached thereto. Incorporated by reference to Exhibit 10.4 to
Report on Form 8K filed with the SEC on November 18,
2004. | |
Exhibit
10.5 |
Amended
and Restated Employment Agreement, dated December 20, 2004, by and between
the Company and J.Todd Derbin. Incorporated by reference to Exhibit 10.1
to Report on Form 8K filed with the SEC on December 23,
2004. | |
Exhibit
10.6 |
2004
Stock Option Plan of the Company. Incorporated by reference to Exhibit
10.1 to Report on Form 8K filed with the SEC on December 27,
2004. | |
Exhibit
10.7 |
License
Agreement, dated as of June 17, 2002, by and between Advaxis and The
Trustees of the University of Pennsylvania*. | |
Exhibit
10.8 |
Non-Exclusive
License and Bailment, dated as of March 17, 2004, betweeen The Regents of
the University of California and Advaxis, Inc. | |
Exhibit
10.9 |
Consultancy
Agreement, dated as of January 19, 2005, by and between LVEP Management,
Inc. and the Company. | |
Exhibit
10.10 |
Government
Funding Agreement, dated as of April 5, 2004, by and between David Carpi
and Advaxis, Inc. | |
Exhibit
10.11 |
Amended
and Restated Consulting and Placement Agreement, dated as of May 28, 2003,
by and between David Carpi and Advaxis, Inc., as
amended | |
Exhibit
10.12 |
Consultancy
Agreement, dated as of January 22, 2005, by and between Dr. Yvonne
Paterson and Advaxis, Inc. | |
Exhibit
10.13 |
Consultancy
Agreement, dated as of March 15, 2003, by and between Dr. Joy A. Cavagnaro
and Advaxis, Inc. | |
Exhibit
10.14 |
Grant
Writing Agreement, dated June 19, 2003, by and between DNA Bridges, Inc.
and Adavaxis, Inc. | |
Exhibit
10.15 |
Consulting
Agreement, dated as of July 2, 2004, by and between Sentinel Consulting
Corporation and Advaxis, Inc. | |
Exhibit
10.16 |
Agreement,
dated July 7, 2003, by and between Cobra Biomanufacturing PLC and Advaxis,
Inc.* | |
Exhibit
10.17 |
Securities
Purchase Agreement, dated as of January 12, 2005, by and between the
Company and Harvest Advaxis LLC. Incorporated by reference to Exhibit 10.1
to Report on Form 8K filed with the SEC on January 18,
2005. | |
Exhibit
10.18 |
Registration
Rights Agreement, dated as of January 12, 2005, by and between the Company
and Harvest Advaxis LLC. Incorporated by reference to Exhibit 10.2 to
Report on Form 8K filed with the SEC on January 18,
2005. | |
Exhibit
10.19 |
Letter
Agreement, dated as of January 12, 2005 by and between the Company and
Robert T. Harvey. Incorporated by reference to Exhibit 10.3 to Report on
Form 8K filed with the SEC on January 18, 2005. | |
Exhibit
10.20 |
Consultantcy
Agreement, dated as of January 15, 2005, by and between Dr. David Filer
and the Company. | |
Exhibit
10.21 |
Consultancy
Agreement, dated as of January 15, 2005, by and between Pharm-Olam
International Ltd. and the Company. | |
Exhibit
10.22 |
Agreement,
dated February 1, 2004, by and between Strategic Growth International Inc.
and the Company. | |
Exhibit
10.23 |
Letter
Agreement, dated February 10, 2005, by and between Richard Berman and the
Company. | |
Exhibit
10.24 |
Employment
Agreement, dated February 8, 2005, by and between Vafa Shahabi and the
Company. | |
Exhibit
10.25 |
Employment
Agreement, dated March 1, 2005, by and between John Rothman and the
Company. | |
Exhibit
14.1 |
Code
of Ethics. Incorporated by reference to Exhibit 14.1 to Report on Form 8K
filed with the SEC on November 18, 2004. | |
Exhibit
21.1 |
Advaxis,
Inc., a Delaware corporation | |
Exhibit
23.1 |
Consent
of Goldstein Golub Kessler LLP | |
Exhibit
23.2 |
Consent
of Frascona, Joiner, Goodman and Greenstein, PC (included in Exhibit 5.1
above) | |
Exhibit
24.1 |
Power
of Attorney (Included on the signature page) | |
---------------------- |
||
*
Confidential Treatment sought. |
ADVAXIS, INC. | ||
|
|
|
By: | /s/ J. Todd Derbin | |
J. Todd Derbin | ||
Chief Executive Officer |
SIGNATURE |
TITLE |
DATE | ||
/s/
J. Todd Derbin |
Chief
Executive Officer and Director |
April
26, 2005 | ||
J.
Todd Derbin |
(Principal
Executive Officer |
|||
* |
Chief
Financial Officer and Director |
April
26, 2005 | ||
Roni
Appel |
(Principal
Financial and Accounting Officer) |
|||
* |
Director |
April
26, 2005 | ||
Scott
Flamm |
||||
* |
Director |
April
26,, 2005 | ||
Thomas
McKearn |
||||
* |
Director |
April
26, 2005 | ||
James Patton | ||||
* |
Director |
April
26, 2005 | ||
Steven
Roth |
||||
*by: /s/ J. Todd Derbin | ||||
J. Todd Derbin | ||||
Attorney-in-fact |