Nevada
|
8731
|
76-0674577
|
(State
or other jurisdiction of incorporation or organization)
|
(Primary
SIC Code)
|
(I.R.S.
Employer Identification No.)
|
Dr.
Eugene Seymour
|
Peter
Campitiello, Esq.
|
135
Wood Street, Suite 205
|
Tarter
Krinsky & Drogin LLP
|
West
Haven, Connecticut 06516
|
1350
Broadway
|
Telephone:
(203) 937-6137
|
New
York, New York 10018
|
Facsimile:
(203) 937-6137
|
Telephone:
(212) 216-8085
|
Facsimile:
(212) 216-8001
|
Title
of Each Class
ofSecurities
to be
Registered
|
Amount
to be Registered
|
Proposed
Maximum Offering Price Per Share (1)
|
Proposed
Maximum Aggregate Offering Price (1)
|
Amount
of Registration Fee
|
||||||||||||
Common
Stock, $0.001 par value per share
|
2,805,000 | $ | 0.40 | $ | 1,122,000 | $ | 44.11 | |||||||||
Common
Stock, $0.001 par value per share, issuable upon exercise of outstanding
warrants
|
450,000 | $ | 0.40 | $ | 180,000 | $ | 7.07 | |||||||||
TOTAL
|
3,255,000 | $ | 0.40 | $ | 1,302,000 | $ | 51.18 |
(1)
|
Estimated
solely for purposes of
calculating the registration fee in accordance with Rule 457(c) under
the
Securities Act of 1933 based on the average of the high and low sale
price
of the common stock as reported on the Over-the-Counter Bulletin
Board on
January 3, 2008.
|
PROSPECTUS
SUMMARY
|
5
|
SUMMARY
FINANCIAL DATA
|
7
|
RISK
FACTORS
|
7
|
SELLING
SECURITY HOLDERS
|
24
|
PLAN
OF DISTRIBUTION
|
25
|
LEGAL
PROCEEDINGS
|
26
|
DIRECTORS
AND EXECUTIVE OFFICERS
|
27
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
|
29
|
DESCRIPTION
OF SECURITIES
|
29
|
INTEREST
OF NAMED EXPERTS AND COUNSEL
|
31
|
DESCRIPTION
OF BUSINESS
|
32
|
FORWARD-LOOKING
STATEMENTS
|
55
|
MANAGEMENT’S
PLAN OF OPERATIONS
|
55
|
CERAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
|
62
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS
|
64
|
RECENT
SALES OF UNREGISTERED SECURITIES
|
64
|
FINANCIAL
STATEMENTS
|
F-1
|
Common
Stock Being Offered By Selling Stockholders
|
3,255,000
shares of Common Stock. This includes (i) 2,805,000 shares of
our issued and outstanding Common Stock and (ii) 450,000 shares of
Common
Stock issuable upon exercise of outstanding
warrants.
|
|
Initial
Offering Price
|
The
initial offering price for shares of our Common Stock will be determined
by prevailing prices established on the OTCBB or as negotiated in
private
transactions, or as otherwise described in “Plan of
Distribution.”
|
|
Terms
of the Offering
|
The
Selling Stockholders will determine when and how they will sell the
Common
Stock offered in this prospectus.
|
|
Termination
of the Offering
|
The
offering will conclude upon the earliest of (i) such time as all
of the
Common Stock has been sold pursuant to the registration statement,
(ii)
two years or (iii) such time as all of the Common Stock become
eligible for resale without volume limitations pursuant to Rule 144
under
the Securities Act of 1933, as amended (the “Securities Act”), or any
other rule of similar effect.
|
|
Use
of Proceeds
|
We
are not selling any shares of Common Stock in this offering and,
as a
result, will not receive any proceeds from this offering. We may,
however,
receive proceeds in the event that some or all of the warrants held
by the
Selling Stockholders are exercised for cash. The proceeds from the
exercise of such warrants, if any, will be used for working capital
and
general corporate purposes.
|
|
OTCBB
Trading Symbol
|
“NNVC.OB”
|
|
Risk
Factors
|
The
Common Stock offered hereby involves a high degree of risk and should
not
be purchased by investors who cannot afford the loss of their entire
investment. See “Risk Factors” beginning on page
7.
|
|
·
|
demonstration
and proof of principle in pre-clinical trials that a viricide is
safe and
effective;
|
|
·
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successful
development of our first product candidates FluCide, AviFluCide,
FluCide
HP, and RabiCide ;
|
|
·
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our
ability to seek and obtain regulatory approvals, including with respect
to
the indications we are seeking;
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·
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the
successful commercialization of our product candidates; and
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·
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market
acceptance of our products.
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–
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the
absence of an operating history;
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–
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the
lack of commercialized products;
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–
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insufficient
capital;
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–
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expected
substantial and continual losses for the foreseeable future;
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–
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limited
experience in dealing with regulatory issues;
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–
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the
lack of manufacturing experience and limited marketing experience;
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–
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an
expected reliance on third parties for the development and
commercialization of our proposed products;
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–
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a
competitive environment characterized by numerous, well-established
and
well capitalized competitors; and
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–
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reliance
on key personnel.
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|
–
|
our
ability to develop drugs, obtain approval for such drugs, and if
approved,
to successfully commercialize our nanoviricide drug;
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–
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our
R&D efforts, including the timing and cost of clinical trials; and
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–
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our
ability to enter into favorable alliances with third-parties who
can
provide substantial capabilities in clinical development, regulatory
affairs, sales, marketing and distribution.
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|
·
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research
and development programs;
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|
·
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preclinical
studies and clinical trials; material characterization studies, regulatory
processes;
|
|
·
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establishment
of our own laboratory or a search for third party marketing partners
to
market our products for us.
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|
·
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progress,
timing and scope of our research and development programs;
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·
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progress,
timing and scope of our preclinical studies and clinical trials;
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·
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time
and cost necessary to obtain regulatory approvals;
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·
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time
and cost necessary to establish our own marketing capabilities or
to seek
marketing partners;
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·
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time
and cost necessary to respond to technological and market developments;
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·
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changes
made or new developments in our existing collaborative, licensing
and
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·
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other
commercial relationships; and
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·
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new
collaborative, licensing and other commercial relationships that
we may
establish.
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·
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enter
into leases for new facilities and capital equipment;
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·
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enter
into additional licenses and collaborative agreements; and
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·
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incur
additional expenses associated with being a public company.
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|
•
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develop
products internally or obtain rights to them from others on favorable
terms;
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|
•
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complete
laboratory testing and human studies;
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|
•
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obtain
and maintain necessary intellectual property rights to our products;
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•
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successfully
complete regulatory review to obtain requisite governmental agency
approvals
|
|
•
|
enter
into arrangements with third parties to manufacture our products
on our
behalf; and
|
|
•
|
enter
into arrangements with third parties to provide sales and marketing
functions.
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·
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are
found to be unsafe or ineffective in clinical trials;
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·
|
do
not receive necessary approval from the FDA or foreign regulatory
agencies;
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|
·
|
fail
to conform to a changing standard of care for the diseases they seek
to
treat; or
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|
·
|
are
less effective or more expensive than current or alternative treatment
methods.
|
|
·
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The
FDA or foreign regulators may interpret data from pre-clinical testing
and
clinical trials in different ways than we interpret them.
|
|
·
|
If
regulatory approval of a product is granted, the approval may be
limited
to specific indications or limited with respect to its distribution.
In
addition, many foreign countries control pricing and coverage under
their
respective national social security systems.
|
|
·
|
The
FDA or foreign regulators may not approve our manufacturing processes
or
manufacturing facilities.
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·
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The
FDA or foreign regulators may change their approval policies or adopt
new
regulations.
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|
·
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Even
if regulatory approval for any product is obtained, the marketing
license
will be subject to continual review, and newly discovered or developed
safety or effectiveness data may result in suspension or revocation
of the
marketing license.
|
|
·
|
If
regulatory approval of the product candidate is granted, the marketing
of
that product would be subject to adverse event reporting requirements
and
a general prohibition against promoting products for unapproved or
“off-label” uses.
|
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·
|
In
some foreign countries, we may be subject to official release requirements
that require each batch of the product we produce to be officially
released by regulatory authorities prior to its distribution by us.
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|
·
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We
will be subject to continual regulatory review and periodic inspection
and
approval of manufacturing modifications, including compliance with
current
GMP regulations.
|
|
·
|
the
number and 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 that we may be required to conduct;
|
|
·
|
the
number of drugs entering into pre-clinical development from 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;
|
|
·
|
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
R&D that we may record as R&D expense.
|
|
·
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significant
time and effort from our management team;
|
|
·
|
coordination
of our marketing and R&D programs with the marketing and R&D
priorities of our collaborators; and
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|
·
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effective
allocation of our resources to multiple projects.
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·
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Our
executive officers or directors or their affiliates may have an economic
interest in, or other business relationship with, partner companies
that
invest in us.
|
|
·
|
Our
executive officers or directors or their affiliates have interests
in
entities that provide products or services to us.
|
|
·
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Our
executive officers or directors may have a conflict between our current
interests and their personal financial and other interests in another
business venture.
|
|
·
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Our
executive officers or directors may have conflicting fiduciary duties
to
us and the other entity.
|
|
·
|
The
terms of transactions with the other entity may not be subject to
arm’s
length negotiations and therefore may be on terms less favorable
to us
than those that could be procured through arm’s length negotiations.
|
|
·
|
suspend
or prevent us for a set period of time from receiving new contracts
or
extending existing contracts based on violations or suspected violations
of laws or regulations;
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·
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terminate
our existing contracts;
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·
|
reduce
the scope and value of our existing contracts;
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·
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audit
and object to our contract-related costs and fees, including allocated
indirect costs;
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|
·
|
control
and potentially prohibit the export of our drug candidates; and
|
|
·
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change
certain terms and conditions in our contracts.
|
·
|
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 a IND and later
NDA,
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 not economical; and
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·
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the
proprietary rights of others and their competing products and technologies
that may prevent the product from being commercialized.
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·
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obtaining
financial and investment information from the investor;
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·
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obtaining
a written suitability questionnaire and purchase agreement signed
by the
investor; and
|
|
·
|
providing
the investor a written identification of the shares being offered
and the
quantity of the shares.
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|
·
|
progress
of our products through the regulatory process;
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·
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results
of preclinical studies and clinical trials;
|
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·
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announcements
of technological innovations or new products by us or our competitors;
|
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·
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government
regulatory action affecting our products or our competitors' products
in
both the United States and foreign countries;
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|
·
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developments
or disputes concerning patent or proprietary rights;
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|
·
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general
market conditions for emerging growth and pharmaceutical companies;
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|
·
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economic
conditions in the United States or abroad;
|
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·
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actual
or anticipated fluctuations in our operating results;
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·
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broad
market fluctuations; and
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·
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changes
in financial estimates by securities analysts.
|
Name
of selling security holder
|
Amount
of
securities
of the
class
owned by
the
security
holder
before
this
offering*
|
Amount
to be
offered
for the
security holder's
account
|
Amount
and
percentage
of the
class
to be owned
by
security
holder
after the
offering
is
complete
|
|||||||||
DKR
Saturn Event Driven Holding Fund Ltd.(1)(2)
|
1,950,000 | 1,950,000 | 0 | % | ||||||||
David
A. Boardman
|
52,500 | 52,500 | 0 | % | ||||||||
Richard
A. Jacobs
|
150,000 | 150,000 | 0 | % | ||||||||
Leighton
C. Klevana
|
52,500 | 52,500 | 0 | % | ||||||||
Greg
Lubar
|
75,000 | 75,000 | 0 | % | ||||||||
Vivian
Boniuk
|
150,000 | 150,000 | 0 | % | ||||||||
Robert and
Julie Kassan
|
150,000 | 150,000 | 0 | % | ||||||||
David
G. Gold
|
125,000 | 125,000 | 0 | % | ||||||||
Robert
I. Gold
|
125,000 | 125,000 | 0 | % | ||||||||
Charles
I. Gold
|
125,000 | 125,000 | 0 | % | ||||||||
Gary
and Linda Nathanson
|
75,000 | 75,000 | 0 | % | ||||||||
Marvin
Rosenberg
|
37,500 | 37,500 | 0 | % | ||||||||
David
Jacofsky
|
37,500 | 37,500 | 0 | % | ||||||||
John
Engerholm
|
37,500 | 37,500 | 0 | % | ||||||||
Doren
Family Trust (3)
|
75,000 | 75,000 | 0 | % | ||||||||
Linden
Group Money Purchase Pension Plan(4)
|
37,500 | 37,500 | 0 | % |
·
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
·
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 resales by the broker-dealer for
its
account;
|
·
an exchange
distribution in accordance with the rules of the applicable
exchange;
|
·
privately
negotiated transactions;
|
·
to
cover
short sales made after the date that the registration statement of
which
this prospectus is a part is declared effective by the
Commission;
|
·
broker-dealers may agree with the selling security holders to sell
a
specified number of such shares at a stipulated price per
share;
|
·
a
combination
of any of these methods of sale; and
|
·
any
other
method permitted pursuant to applicable
law.
|
Name
|
Age
|
Title
|
Anil
Diwan, PhD.
|
49
|
President;
Chairman of the Board
|
Eugene
Seymour, MD, MPH
|
66
|
Chief
Executive and Financial Officer; Director
|
Leo
Ehrlich
|
47
|
Chief
Financial Officer, Director -Resigned May 16,
2007
|
|
·
|
Dr.
Anil Diwan received 1,000,000 options, 333,333 options vested upon
execution of the employment agreement. The remaining options vest
in equal
amounts on January 1, 2007 (333,333 options) and January 1, 2008
(333,334
options). The options expire September 26, 2015.
|
|
·
|
Dr.
Eugene Seymour received 500,000 options, 250,000 options vested upon
execution of the employment agreement. The remaining options vest
in equal
amounts on January 1, 2007 (125,000 options) and January 1, 2008
(125,000
options). The options expire September 26, 2015.
|
Name
and Address of Beneficial
Owner
|
Amount
and Nature of Beneficial
Ownership (1)
|
Percent
of Class (2)
|
|||||
TheraCour
Pharma, Inc.(3)(4)
|
35,370,000 | 30.0 | % | ||||
Anil
Diwan (3)(4)
|
11,000,000 | 9.2 | % | ||||
Eugene
Seymour (5)
|
9,000,000 | 7.6 | % | ||||
Leo Ehrlich (6) | 9,275,000 | 7.8 | % | ||||
All
executive officers and directors as a group (3 persons)(6)
|
64,645,000 | 54.3 | % |
(1)
|
"Beneficial
Owner" means having
or sharing, directly or indirectly (i) voting power, which includes
the
power to vote or to direct the voting, or (ii) investment power,
which
includes the power to dispose or to direct the disposition, of shares
of
the common stock of an issuer. The definition of beneficial ownership
includes shares, underlying options or warrants to purchase common
stock,
or other securities convertible into common stock, that currently
are
exercisable or convertible or that will become exercisable or convertible
within 60 days. Unless otherwise indicated, the beneficial owner
has sole
voting and investment power.
|
(2)
|
For
each shareholder, the
calculation of percentage of beneficial ownership is based upon
119,038,498 shares of Common Stock outstanding as of December 21
2007, and shares of Common Stock subject to options, warrants and/or
conversion rights held by the shareholder that are currently exercisable
or exercisable within 60 days, which are deemed to be outstanding
and to
be beneficially owned by the shareholder holding such options, warrants,
or conversion rights. The percentage ownership of any shareholder
is
determined by assuming that the shareholder has exercised all options,
warrants and conversion rights to obtain additional securities and
that no
other shareholder has exercised such
rights.
|
(3)
|
Anil
Diwan, President and
Chairman of the Board of Directors. Includes 10,000,000 shares of
NanoViricides common stock held by Mr. Diwan and 1,000,000 shares
of
NanoViricides common stock issuable upon exercise of options held
by Mr.
Diwan that are currently exercisable or will become exercisable within
60
days.
|
(4)
|
Anil
Diwan, the Company’s
President and Chairman, also serves as the CEO and Director of TheraCour
Pharma Inc. and owns approximately 65% of the outstanding capital
stock of
TheraCour. Anil Diwan has both investment and dispositive power over
the
NanoViricides shares held by TheraCour Pharma,
Inc.
|
(5)
|
Eugene
Seymour, Chief Executive
Officer and Director. Includes 8,500,000 shares of NanoViricides
common
stock held by Dr. Seymour and 500,000 shares of NanoViricides common
stock
issuable upon exercise of options held by Dr. Seymour that are currently
exercisable or will become exercisable within 60
days.
|
(6) |
Leo
Ehrlich, formerly Chief Financial Officer and Director. Includes
5,600,000
shares of NanoViricides common stock held by Mr. Ehrlich and includes
3,500,000 shares of NanoViricides common stock held by the wife and
children of Leo Ehrlich, and 375,000 shares of NanoViricides common
stock
issuable upon exercise of options held by Mr. Ehrlich that are currently
exercisable or will become exercisable within 60
days.
|
(7)
|
Includes
35,370,000 shares of
Common Stock indirectly owned by certain of the Executive Officers
(including Leo Ehrlich) and Directors as a
group.
|
1.
|
Each
nanoviricide drug is
designed as a specifically targeted antiviral agent for a particular
type
of virus or group of viruses. Often side effects of a drug may be
correlated with non-specific interactions with the host cells, tissues,
and organs. Most existing anti-viral agents are known to have non-specific
effects against both host cells and viral machinery at the same
time.
|
2.
|
A
nanoviricide is designed to
seek and attach to a specific virus particle, engulfing the virus
particle
in the process, thereby rendering it incapable of infecting new cells,
and
disabling it completely. This suggested mechanism of action comprises
much
more than what the current entry and fusion inhibitors are expected
to do.
The fusion and entry inhibitors do not completely cover the virus
particle
and likely block only a few sites on the virus particle, which means
the
virus particle may still be capable of infecting cells using its
unblocked
attachment sites. In contrast, a nanoviricide is expected to engulf
the
virus particle completely, because of its larger size and flexible
nature,
thus disabling it completely. The action of a nanoviricide, if it
works as
designed, in this regard may be expected to be superior to antibody
agents
that attack viruses as well. Antibodies, being large, are expected
to
block relatively greater portions of the virus particle surface compared
to small molecule entry inhibitors. However, antibodies depend upon
the
human immune system responses for clearing up the virus particle.
In
contrast, nanoviricides are thought to be capable of acting as completely
programmed chemical robots that finish their task of destroying the
virus
particle on their own.
|
3.
|
A
nanoviricide is designed to be
capable of encapsulating an active pharmaceutical ingredient (API)
in its
core, or “belly”. This is expected to reduce toxic effects of the API.
Such encapsulating methods are currently being used in anti-cancer
therapy
and have shown reduced toxicity as well as increased efficacy (see
http://nihroadmap.nih.gov/nanomedicine/)
. Our goal, which can give no
assurance that we will achieve, is for NanoViricides, Inc. to be
the
premier company to develop nanomedicines for anti-viral
therapy.
|
4.
|
A
nanoviricide is designed to
deliver any encapsulated API directly into the core of the virus
particle.
This is proposed to result in maximal effect against the anti-viral
targets, such as the viral genomic materials. Our goal for this
specifically targeted delivery of the API is to minimize toxic effects
and
also improve efficacy of the API. (see http://www.nci.nih.gov).
|
5.
|
With
this concerted targeted set
of mechanisms, our objective is for the nanoviricide to be programmed
to
(a) prevent the virus particle from being able to infect new cells,
(b)
dismantle the virus particle, and (c) destroy the genetic material
of the
virus particle, thereby completely destroying the target. Our complete
systems engineered approach to anti-viral therapy is in stark contrast
with the current piece-meal approaches. Current drug therapies often
have
extensive toxicities, limited efficacies, and generation of mutants
(mutated viruses) through selective incomplete pressure applied by
the
therapeutic regime onto the
virus.
|
1.
|
The
Writing Committee of the
World Health Organization (WHO) Consultation on Human Influenza A/H5.
Avian influenza A (H5N1) infection in humans. N Engl J Med
2005;353:1374-1385.
|
2.
|
Hien
TT, Liem NT, Dung NT, et al.
Avian influenza A (H5N1) in 10 patients in Vietnam. N Engl J Med
2004;350:1179-1188.
|
3.
|
Chotpitayasunondh
T, Ungchusak K,
Hanshaoworakul W, et al. Human disease from influenza A (H5N1), Thailand,
2004. Emerg Infect Dis
2005;11:201-209.
|
4.
|
Moscona
A. Neuraminidase
inhibitors for influenza. N Engl J Med
2005;353:1363-1373.
|
5.
|
Identification
of influenza
isolates by hemagglutination inhibition. In: Department of Communicable
Disease Surveillance and Response. WHO manual on animal influenza
diagnosis and surveillance. Geneva: World Health Organization, 2002:28-36.
(WHO/CDS/CSR/NCS/2002.5.)
|
6.
|
de
Jong MD, Cam BV, Qui PT, et
al. Fatal avian influenza A (H5N1) in a child presenting with diarrhea
followed by coma. N Engl J Med
2005;352:686-691.
|
7.
|
Boom
R, Sol C, Beld M, Weel J,
Goudsmit J, Wertheim-van Dillen P. Improved silica-guanidiniumthiocyanate
DNA isolation procedure based on selective binding of bovine alpha-casein
to silica particles. J Clin Microbiol
1999;37:615-619.
|
8.
|
Boom
R, Sol CJ, Salimans MM,
Jansen CL, Wertheim-van Dillen PM, van der Noordaa J. Rapid and simple
method for purification of nucleic acids. J Clin Microbiol
1990;28:495-503.
|
9.
|
Chen
H, Smith GJ, Zhang SY, et
al. Avian flu: H5N1 virus outbreak in migratory waterfowl. Nature
2005;436:191-192.
|
10.
|
Gubareva
LV, Kaiser L,
Matrosovich MN, Soo-Hoo Y, Hayden FG. Selection of influenza virus
mutants
in experimentally infected volunteers treated with oseltamivir. J
Infect
Dis 2001;183:523-531.
|
11.
|
Le
QM, Kiso M, Someya K, et al.
Avian flu: isolation of drug-resistant H5N1 virus. Nature
2005;437:1108-1108.
|
12.
|
Whitley
RJ, Hayden FG, Reisinger
KS, et al. Oral oseltamivir treatment of influenza in children. Pediatr
Infect Dis J 2001;20:127-133. [Erratum, Pediatr Infect Dis J
2001;20:421.]
|
13.
|
Kiso
M, Mitamura K, Sakai-Tagawa
Y, et al. Resistant influenza A viruses in children treated with
oseltamivir: descriptive study. Lancet
2004;364:759-765.
|
14.
|
Ward
P, Small I, Smith J, Suter
P, Dutkowski R. Oseltamivir (Tamiflu) and its potential for use in
the
event of an influenza pandemic. J Antimicrob Chemother 2005;55:Suppl
1:i5-i21.
|
15.
|
Yen
HL, Monto AS, Webster RG,
Govorkova EA. Virulence may determine the necessary duration and
dosage of
oseltamivir treatment for highly pathogenic A/Vietnam/1203/04 influenza
virus in mice. J Infect Dis
2005;192:665-672.
|
16.
|
Maines
TR, Lu XH, Erb SM, et al.
Avian influenza (H5N1) viruses isolated from humans in Asia in 2004
exhibit increased virulence in mammals. J Virol
2005;79:11788-11800.
|
Virus
|
Development
Stage
|
Influenza
(Common)
|
Preclinical
|
Avian
Flu (H5N1)
|
Preclinical
|
Avian
Flu-Highly Pathogenic
|
Preclinical
|
Rabies
|
Preclinical
|
HIV/AIDS
|
Early
R&D
|
HCV
|
R&D
to begin in 2008
|
Dengue
|
Early
R&D
|
Table
1: Intellectual Property, Patents and Pending Patents Licensed by
The
Company
|
||||||||
Patent
or Application
|
Date
of Issue/Application
|
US
Expiry Date
|
International
|
Owners
|
||||
US6,521,736
(Certain specific amphiphilic polymers).
|
Issued:
Feb 18, 2003
|
Feb
18, 2020
|
N/A
|
TheraCour
Pharma and Univ. of Massachusetts, Lowell. [Nonexclusive license
from
TheraCour Pharma].
|
||||
PCT/US06/01820(SOLUBILIZATION
AND TARGETED DELIVERY OF DRUGS WITH SELF-ASSEMBLING AMPHIPHILIC
POLYMERS).
|
Applied:
Jan 19, 2006PCT Application.
|
Jan
18, 2023 (estimated)
|
Applications
to be filed.
|
TheraCour
Pharma, Inc. [Exclusive License].
|
||||
SELF-ASSEMBLING
AMPHIPHILIC POLYMERS AS ANTIVIRAL AGENTS
|
Applied:
Jan 22, 2007
|
Jan
21, 2024 (estimated)
|
Applications
to be filed.
|
TheraCour
Pharma, Inc. [Exclusive License].
|
|
·
|
efficacy;
|
|
·
|
safety;
|
|
·
|
tolerability;
|
|
·
|
acceptance
by
doctors;
|
|
·
|
patient
compliance;
|
|
·
|
patent
protection;
|
|
·
|
ease
of
use;
|
|
·
|
price;
|
|
·
|
insurance
and other reimbursement
coverage;
|
|
·
|
distribution;
|
|
·
|
marketing;
and
|
|
·
|
adaptability
to various modes of
dosing.
|
1
|
Research
and Development of
$1,500,000: Includes planned costs of $1,200,000 for multiple drug
variations and in-vivo and in-vitro studies for FluCide-1™, AviFluCide™,
FluCide HP™, and Rabies planned for the year ended June 30, 2008. The
Company has allocated the planned costs of $1,200,000 evenly over
the four
drugs ($300,000 each). Depending on the results of these clinical
trials,
we expect to commence with early stage development of a drug for
HIV for
which we have budgeted
$300,000.
|
2
|
Corporate
overhead of $750,000:
This amount includes budgeted office salaries, legal, accounting
and other
costs expected to be incurred by being a public reporting
company.
|
3
|
Capital
costs of $1,250,000: This
is the estimated cost for equipment and laboratory improvements.
The
Company plans to incur these costs if the planned trials in the third
calendar quarter of 2007 show improvement over present
treatments.
|
4
|
Staffing
costs of $1,500,000:
This is the estimated cost of hiring additional scientific staff
and
consulting firms to assist with FDA compliance, material characterization,
pharmaco-kinetic, pharmaco-dynamic and toxicology studies, as required
for
development of necessary data for filing an Investigational New Drug
Application (IND) with the United States Food and Drug
Administration.
|
Project
|
Drug
Development of FluCide™ for Common Influenza
|
Current
status
|
FluCide-I,
is currently in preclinical studies against all common influenzas
as well
as avian influenza H5N1. It is a broad-spectrum anti-influenza
nanoviricide. It is based on a well known ligand mechanism by which
influenza viruses bind to cells. This mechanism involves the hemagglutinin
coat protein of influenza virus binding to sialic acids on cell surfaces.
FluCide-I has been tested in cell cultures and in mice and has
demonstrated better results than oseltamivir. The Company is planning
in-vivo and in-vitro studies with FluCide-I at the Vietnam National
Institute of Hygiene and Epidemiology (NIHE) during the year ended
June
30, 2008.
|
Nature,
timing and estimated costs
|
We
expect to know in early
2008 whether we will continue with FluCide-I as a drug candidate. The
Company has budgeted approximately $500,000 for the material development,
production and testing of this drug during the first calendar quarter
of
2008 . These costs will be paid from our available cash balances.
Should
management determine the results to be satisfactory, we will need
to
obtain additional financing to perform material characterization,
pharmaco-kinetic, pharmaco-dynamic and toxicology studies which we
have
presently budgeted at $1,000,000.
|
Anticipated
completion date
|
Not
known
|
Risks
and uncertainties associated with completing development on schedule,
and
the consequences to operations, financial position and liquidity
if not
completed timely
|
The
outcome of clinical testing can not be known at this time, and this
poses
substantial risk and uncertainty as to whether or when if ever, this
drug
will become marketable.
|
Timing
of commencement of expected material net cash inflows
|
It
is not known or estimable when net cash inflows from this project
will
commence if ever, due to the uncertainties associated with the completion
of the product, regulatory submissions, approvals and market purchases
of
this product.
|
Project
|
Drug
Development of AviFluCide™ for Avian Influenza
|
Current
status
|
AviFluCide,
is currently in
preclinical studies against avian influenza H5N1. It is a specific
H5N1
anti-influenza nanoviricide. It is based on an antibody provided
tous by
the NIHE, Vietnam by which influenza viruses bind to cells. AviFluCide
has
been tested in cell cultures and has demonstrated better results
than
oseltamivir. The Company is planning in-vivo and in-vitro studies
with
AviFluCide at the Vietnam National Institute of Hygiene and Epidemiology
(NIHE) during the year ended June 30, 2008
|
Nature,
timing and estimated costs
|
We
expect to know by the end of
December 2008 whether we will continue with AviFluCide as a drug
candidate. The Company has budgeted approximately $500,000 for the
material development, production and testing of this drug during
Q1 2007
at NIHE. These costs will be paid from our available cash balances.
Should
management determine the results to be satisfactory, we will need
to
obtain additional financing to perform material characterization,
pharmaco-kinetic, pharmaco-dynamic and toxicology studies which we
have
presently budgeted at $1,000,000.
|
Anticipated
completion date
|
Not
known
|
Risks
and uncertainties
associated with completing development on schedule, and the consequences
to operations, financial position and liquidity if not completed
timely
|
The
outcome of clinical testing can not be known at this time, and this
poses
substantial risk and uncertainty as to whether or when if ever, this
drug
will become marketable.
|
Timing
of commencement of expected material net cash inflows
|
It
is not known or estimable when net cash inflows from this project
will
commence if ever, due to the uncertainties associated with the completion
of the product, regulatory submissions, approvals and market purchases
of
this product.
|
Project
|
Drug
Development of FluCideHP™ for High Pathogenic Influenza
|
Current
status
|
FluCideHP,
is currently in preclinical studies against all common influenzas
as well
as avian influenza H5N1. It is a broad-spectrum anti-influenza
nanoviricide. It is based on a well known ligand mechanism by which
influenza viruses become highly pathogenic cells. This mechanism
involves
the hemagglutinin coat protein of influenza virus protein called
the
polybasic site. FluCideHP has been tested in cell cultures and in
mice and
has demonstrated better results than oseltamivir. The Company is
planning
in-vivo and in-vitro studies with FluCideHP at the Vietnam National
Institute of Hygiene and Epidemiology (NIHE) and other facilities,
including KARD Scientific, during the year ended June 30,
2008
|
Nature,
timing and estimated costs
|
The
Company has budgeted
approximately $500,000 for the material development, production and
testing of this drug during the year ending June 30, 2008. These
costs
will be paid from our available cash balances. Should management
determine
the results to be satisfactory, we will need to obtain additional
financing to perform material characterization, pharmaco-kinetic,
pharmaco-dynamic and toxicology studies which we have presently budgeted
at $1,000,000.
|
Anticipated
completion date
|
Not
known
|
Risks
and uncertainties associated with completing development on schedule,
and
the consequences to operations, financial position and liquidity
if not
completed timely
|
The
outcome of clinical testing can not be known at this time, and this
poses
substantial risk and uncertainty as to whether or when if ever, this
drug
will become marketable.
|
Timing
of commencement of expected material net cash inflows
|
It
is not known or estimable when
net cash inflows from this project will commence if ever, due to
the
uncertainties associated with the completion of the product, regulatory
submissions, approvals and market purchases of this product.
|
Project
|
Drug
Development of RabiCide™ for Rabies
|
Current
status
|
RabiCide,is
currently in preclinical
studies against rabies. It is a broad-spectrum anti-influenza
nanoviricide. It is based on a well known ligand mechanism by which
rabies
viruses bind to cells. Rabicide has been successfully tested in mice.
The
Company is planning the first in-vivo and in-vitro studies with RabiCide
at the Vietnam National Institute of Hygiene and Epidemiology (NIHE)
during 2008.
|
Nature,
timing and estimated costs
|
The
Company has budgeted
approximately $300,000 for the material development, production and
testing of this drug at NIHE. These costs will be paid from our available
cash balances. Should management determine the results to be satisfactory,
we will need to obtain additional financing to perform material
characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology
studies which we have presently budgeted at
$375,000.
|
Anticipated
completion date
|
Not
known
|
Risks
and uncertainties associated with completing development on schedule,
and
the consequences to operations, financial position and liquidity
if not
completed timely
|
The
outcome of clinical testing can not be known at this time, and this
poses
substantial risk and uncertainty as to whether or when if ever, this
drug
will become marketable.
|
Timing
of commencement of expected material net cash inflows
|
It
is not known or estimable when net cash inflows from this project
will
commence if ever, due to the uncertainties associated with the completion
of the product, regulatory submissions, approvals and market purchases
of
this product.
|
Quarter
ended
|
Low
price
|
High
price
|
||||||
December 31, 2007 | $ | .33 | $ | .72 | ||||
September
30, 2007
|
$ | .48 | $ | 1.04 | ||||
June
30, 2007
|
$ | .80 | $ | .99 | ||||
March
31, 2007
|
$ | 1.10 | $ | 1.79 | ||||
December
31, 2006
|
$ | .60 | $ | 1.22 | ||||
September
30, 2006
|
$ | .99 | $ | 1.68 | ||||
June
30, 2006
|
$ | 1.06 | $ | 3.05 | ||||
March,
31, 2006
|
$ | .83 | $ | 3.75 | ||||
December
31, 2005
|
$ | .03 | $ | 1.27 | ||||
September
30, 2005
|
$ | .05 | $ | .30 | ||||
June
1, 2005 to June 30, 2005 (1)
|
$ | .04 | $ | .33 |
(1)
|
Effective
date of reverse merger,
June 1, 2005
|
SEC
Registration Fee
|
$ | 50 | ||
Legal
Fees and Expenses
|
$ | 17,000 | ||
Accounting
Fees and Expenses
|
$ | 7,000 | ||
Miscellaneous
|
$ | 3,000 | ||
TOTAL
|
$ | 27,050 |
Exhibit
No.
|
Description
|
|
3.1
|
Articles
of Incorporation, as amended, of the Registrant (1)
|
|
3.2
|
By-laws
of the Registrant(1)
|
|
4.1
|
Specimen
Stock Certificate of the Registrant(1)
|
|
4.2
|
Subscription
Agreement with DKR Saturn Event Driven Holding Fund
Ltd.(2)
|
|
4.3
|
Form
of Warrant (2)
|
|
4.4
|
Registration
Rights Agreement with DKR Saturn Event Driven Holding Fund
Ltd.(2)
|
|
Opinion
of Tarter Krinsky & Drogin LLP (3)
|
||
10.1
|
Share
Exchange Agreement between NanoViricide, Inc. and the
Registrant(1)
|
|
10.2
|
Employment
agreement Eugene Seymour(1)
|
|
10.3
|
Employment
agreement Anil Diwan(1)
|
|
10.4
|
Employment
agreement Leo Ehrlich(1)
|
|
10.5
|
Form
of Scientific Advisory Board Agreement(1)
|
|
10.6
|
Amended
License Agreement with TheraCour Pharma, Inc. (1)
|
|
10.7
|
Lease
with landlord(1)
|
|
10.8
|
Form
of First Subscription Agreement(1)
|
|
10.9
|
Form
of Second Subscription Agreement(1)
|
|
10.10
|
Code
of Ethics(1)
|
|
10.11
|
Amended
Agreement #2 with TheraCour Pharma, Inc. (1)
|
|
10.12
|
Memorandum
of Understanding with Vietnam’s National Institute of Hygiene and
Epidemiology (NIHE) dated December 23, 2005(1)
|
|
21.1
|
List
of Subsidiaries (3)
|
|
Consent
of Holtz Rubenstein Reminick LLP (3)
|
||
24.1
|
Power
of Attorney (4)
|
Signature
|
Title
|
Date
|
||
/s/Eugene
Seymour
|
Director
and Chief Executive and
|
January
3, 2008
|
||
Eugene
Seymour
|
Financial
Officer
|
|||
/s/
Anil Diwan
|
President
and Chairman
|
January
3, 2008
|
||
Anil Diwan
|
NanoViricides,
Inc.
|
|||
By:
|
/s/
Eugene Seymour
|
||
Name:
Eugene Seymour
|
|||
Title:
President
|
Page
|
||
Report
of Independent Registered Public Accounting Firm for the years ended
June
30, 2007 and 2006
|
F-1
|
|
Audited
Financial
Statements for the Years Ended June 30, 2007 and
2006
|
||
Balance
Sheets for the Years Ended June 30, 2007 and 2006
|
F-2
|
|
Statements
of Operations for the Years Ended June 30, 2007 and 2006 and for
the
Cumulative Period May 12, 2005 (Inception) through June 30,
2007
|
F-3
|
|
Statements
of Changes in Stockholders’ Equity (Deficit) for the Cumulative Period May
12, 2005 (Inception) through June 30, 2007
|
F-4
|
|
Statements
of Cash Flows for the Years Ended June 30, 2007 and 2006 and for
the
Cumulative Period May 12, 2005 (Inception) through June 30,
2007
|
F-8
|
|
Notes
to Financial Statements for the Years Ended June 30, 2007 and
2006
|
F-11
|
|
Unaudited
Financial
Statements as of September 30, 2007
|
||
Balance
Sheet as of September 30, 2007 (Unaudited) and June 30, 2007
(Audited)
|
F-24
|
|
Statements
of Operations (Unaudited) for the Three Months Ended September, 2007
and
2006 and for the Cumulative Period May 12, 2005 (Inception) through
September 30, 2007
|
F-25
|
|
Statements
of Cash Flows(Unaudited) for the Three Months ended September 30,
2007 and
2006 and for the Cumulative Period May 12, 2005 (Inception) through
September 30, 2007
|
F-26
|
|
Notes
to Financial Statements as of September30, 2007 and
2006 (Unaudited)
|
F-28
|
|
|
June 30, 2007
|
|
|
June 30, 2006
as
(Restated)
|
|
||
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
||||||
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
967,797
|
|
|
$
|
2,507,102
|
|
Prepaids-
related parties
|
236,722
|
213,728
|
||||||
Other
current assets
|
20,000
|
|
-
|
|||||
|
|
|
||||||
Total
current assets
|
|
|
1,224,519
|
|
|
|
2,720,830
|
|
|
|
|
||||||
Property
and equipment, net
|
|
|
18,487
|
|
|
|
2,054
|
|
OTHER
ASSETS:
|
||||||||
Deferred
expenses, net
|
-
|
|
|
|
6,714
|
|||
Security
deposit
|
100,000
|
-
|
||||||
Trademark,
net
|
7,215
|
-
|
||||||
|
|
|
||||||
Total
other assets
|
107,215
|
6,714
|
||||||
TOTAL
ASSETS
|
|
$
|
1,350,221
|
|
|
$
|
2,729,598
|
|
|
|
|
||||||
LIABILITIES
AND SHAREHOLDERS’
EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
||||||
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
72,845
|
|
|
$
|
44,076
|
|
Accounts
payable – related parties
|
262,038
|
|
|
|
203,045
|
|||
Accrued
expenses
|
|
|
65,000
|
|
|
|
90,831
|
|
Accrued
payroll to officers and related payroll tax
expense
|
|
|
450,000
|
|
|
|
232,282
|
|
Other
payroll taxes payable
|
-
|
3,826
|
||||||
|
|
|
||||||
TOTAL
CURRENT LIABILITIES
|
|
|
849,883
|
|
|
|
574,060
|
|
LONG
TERM DEBT:
|
||||||||
Debentures,
net
|
-
|
917,082
|
||||||
TOTAL
LONG TERM DEBT
|
|
|
-
|
|
|
|
917,082
|
|
TOTAL
LIABILITIES
|
849,883
|
1,491,142
|
||||||
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
||||||
SHAREHOLDERS’
EQUITY (DEFICIT)
|
|
|
|
|||||
Common
stock, $0.001 par value; 300,000,000 shares authorized at June 30,
2007
and 2006; issued and outstanding: 114,069,144 (2007) and 108,878,425
(2006)
|
|
|
114,069
|
|
|
|
108,878
|
|
Additional
paid-in capital
|
|
|
6,855,689
|
|
|
4,480,035
|
||
Stock
subscription receivable
|
(20
|
)
|
(20
|
)
|
||||
Deficit
accumulated during the development stage
|
|
|
(6,469,400
|
)
|
|
|
(3,350,437
|
)
|
|
|
|||||||
TOTAL
SHAREHOLDERS’ EQUITY
|
|
|
500,338
|
|
|
1,238,456
|
||
|
|
|
||||||
TOTAL
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|
$
|
1,350,221
|
|
|
$
|
2,729,598
|
|
Year
Ended
June 30, 2007
|
Year Ended
June 30, 2006
|
For
the Cumulative
Period
From
May 12, 2005
(Inception)
Through
June 30, 2007
|
||||||||||
|
|
|
|
|||||||||
Revenues
|
$ |
-
|
$ |
-
|
$ |
-
|
||||||
Operating
expenses:
|
||||||||||||
Research
and development
|
731,808
|
899,891
|
1,662,470
|
|||||||||
General
and administrative (of this amount $453,201, $427,703 and
$880,904 was for stock and option based compensation to consultants
and
officers)
|
2,351,104
|
1,695,957
|
4,082,295
|
|||||||||
Total
operating expenses
|
3,082,912
|
2,595,848
|
5,744,765
|
|||||||||
Loss
from operations
|
(3,082,912 | ) | (2,595,848 | ) | (5,744,765 | ) | ||||||
Other
income (expenses)
|
||||||||||||
Interest
income
|
54,511
|
7,863
|
62,374
|
|||||||||
Non
cash interest on convertible debentures
|
(7,644 | ) | (66,286 | ) | (73,930 | ) | ||||||
Non
cash interest expense on beneficial conversion feature of
convertible debentures
|
(82,918 | ) | (630,161 | ) | (713,079 | ) | ||||||
Total
other expenses
|
(36,051 | ) | (688,584 | ) | (724,635 | ) | ||||||
Net
loss to common stockholders
|
$ | (3,118,963 | ) | $ | (3,284,432 | ) | $ | (6,469,400 | ) | |||
Net
loss per share: basic and diluted
|
$ | (0.03 | ) | $ | (0.03 | ) | ||||||
Weighted
average shares outstanding: basic and diluted
|
112,255,669
|
103,591,691
|
Common
Stock
|
||||||||||||||||||||||||
Additional
|
Stock
|
Total
|
||||||||||||||||||||||
Number
|
Par
|
Paid-in
|
Subscription
|
Accumulated
|
Shareholders'
|
|||||||||||||||||||
of
Shares
|
Value
|
Capital
|
Receivable
|
Deficit
|
Equity
|
|||||||||||||||||||
Shares
issued May 12, 2005 (Inception)
|
20,000
|
$ |
20
|
$ |
-
|
$ | (20 | ) | $ |
-
|
$ |
-
|
||||||||||||
Share
exchange with Edot-com.com Inc., June 1, 2005
|
(20,000 | ) | (20 | ) |
-
|
20
|
-
|
-
|
||||||||||||||||
Shares
exchanged in reverse acquisition of Edot-com.com Inc., June 1,
2005
|
80,000,000
|
80,000
|
(79,980 | ) | (20 | ) |
-
|
-
|
||||||||||||||||
Shares
outstanding Edot-com.com
Inc., June 1,
2005
|
20,000,000
|
20,000
|
(20,000 | ) |
-
|
-
|
-
|
|||||||||||||||||
Net
loss period ended June 30, 2005
|
-
|
-
|
-
|
-
|
(66,005 | ) | (66,005 | ) | ||||||||||||||||
Balance
at June 30, 2005 (as
restated)
|
100,000,000
|
100,000
|
(99,980 | ) | (20 | ) | (66,005 | ) | (66,005 | ) | ||||||||||||||
Discount
related to beneficial conversion feature of Convertible debentures,
July 13, 2005
|
-
|
-
|
5,277
|
-
|
-
|
5,277
|
||||||||||||||||||
Legal
expenses related private placement of common stock, July 31,
2006
|
-
|
-
|
(2,175 | ) | (2,175 | ) | ||||||||||||||||||
Discount
related to beneficial conversion feature of Convertible debentures,
July 31, 2005
|
-
|
-
|
5,302
|
-
|
-
|
5,302
|
||||||||||||||||||
Warrants
issued to Scientific Advisory Board, August 15, 2005
|
-
|
-
|
4,094
|
-
|
-
|
4,094
|
||||||||||||||||||
Options
issued to officers, September 23, 2005
|
-
|
-
|
87,318
|
-
|
-
|
87,318
|
||||||||||||||||||
Shares
issued for consulting services rendered at $.081 per share,
September 30, 2005
|
2,300,000
|
2,300
|
184,000
|
-
|
-
|
186,300
|
||||||||||||||||||
Shares
issued for interest on debentures, September 30, 2005
|
48,177
|
48
|
4,267
|
-
|
-
|
4,315
|
||||||||||||||||||
Discount
related to beneficial conversion feature of Convertible debentures,
October 28, 2005
|
-
|
-
|
166,666
|
-
|
-
|
166,666
|
||||||||||||||||||
Discount
related to beneficial conversion feature of Convertible debentures,
November 9, 2005
|
-
|
-
|
166,667
|
-
|
-
|
166,667
|
Common
Stock
|
||||||||||||||||||||||||
Additional
|
Stock
|
Total
|
||||||||||||||||||||||
Number
|
Par
|
Paid-in
|
Subscription
|
Accumulated
|
Stockholders'
|
|||||||||||||||||||
of
Shares
|
Value
|
Capital
|
Receivable
|
Deficit
|
Equity
|
|||||||||||||||||||
Discount
related to beneficial conversion feature of Convertible debentures,
November 10, 2005
|
-
|
-
|
45,000
|
-
|
-
|
45,000
|
||||||||||||||||||
Discount
related to beneficial conversion feature of Convertible debentures,
November 11, 2005
|
-
|
-
|
275,000
|
-
|
-
|
275,000
|
||||||||||||||||||
Discount
related to beneficial conversion feature of Convertible debentures,
November 15, 2005
|
-
|
-
|
49,167
|
-
|
-
|
49,167
|
||||||||||||||||||
Warrants
issued to Scientific Advisory Board, November 15,
2005
|
-
|
-
|
25,876
|
-
|
-
|
25,876
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
November 28, 2005
|
340,000
|
340
|
169,660
|
-
|
-
|
170,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
November 29, 2005
|
300,000
|
300
|
149,700
|
-
|
-
|
150,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
November 30, 2005
|
150,000
|
150
|
74,850
|
-
|
-
|
75,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 2, 2005
|
100,000
|
100
|
49,900
|
-
|
-
|
50,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 6, 2005
|
850,000
|
850
|
424,150
|
-
|
-
|
425,000
|
||||||||||||||||||
Shares
issued for legal services rendered at $.95 per share, December 6,
2005
|
20,000
|
20
|
18,980
|
-
|
-
|
19,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 12, 2005
|
750,000
|
750
|
374,250
|
-
|
-
|
375,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 13, 2005
|
50,000
|
50
|
24,950
|
-
|
-
|
25,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 14, 2005
|
50,000
|
50
|
24,950
|
-
|
-
|
25,000
|
||||||||||||||||||
Shares
issued in connection with debenture offering, December 15,
2005
|
50,000
|
50
|
48,950
|
-
|
-
|
49,000
|
Common
Stock
|
||||||||||||||||||||||||
Additional
|
Stock
|
Total
|
||||||||||||||||||||||
Number
|
Par
|
Paid-in
|
Subscription
|
Accumulated
|
Stockholders'
|
|||||||||||||||||||
Of
Shares
|
Value
|
Capital
|
Receivable
|
Deficit
|
Equity
|
|||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 20, 2005
|
50,000
|
50
|
24,950
|
-
|
-
|
25,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 29, 2005
|
50,000
|
50
|
24,950
|
-
|
-
|
25,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
December 30, 2005.
|
50,000
|
50
|
24,950
|
-
|
-
|
25,000
|
||||||||||||||||||
Shares
issued for interest on debentures, December 31, 2005
|
19,476
|
19
|
17,321
|
-
|
-
|
17,340
|
||||||||||||||||||
Shares
issued for consulting services rendered at $1.46 per share,
January 9, 2006
|
3,425
|
4
|
4,997
|
-
|
-
|
5,001
|
||||||||||||||||||
Warrants
issued to Scientific Advisory Board on February 15,
2006
|
-
|
-
|
49,067
|
-
|
-
|
49,067
|
||||||||||||||||||
Warrants
issued to Scientific Advisory Board on May 15, 2006
|
-
|
-
|
51,048
|
-
|
-
|
51,048
|
||||||||||||||||||
Shares
issued for interest on debentures, March 31, 2005
|
7,921
|
8
|
22,184
|
-
|
-
|
22,192
|
||||||||||||||||||
Options
exercised, May 31, 2006
|
1,800,000
|
1,800
|
88,200
|
-
|
-
|
90,000
|
||||||||||||||||||
Shares
and warrants issued in connection with private placement of
common stock,
June 15, 2006
|
1,875,000
|
1,875
|
1,873,125
|
-
|
-
|
1,875,000
|
||||||||||||||||||
-
|
||||||||||||||||||||||||
Shares
issued for interest on debentures, June 30, 2006
|
14,426
|
14
|
22,424
|
-
|
-
|
22,438
|
||||||||||||||||||
Net
loss year ended June 30, 2006.
|
-
|
-
|
-
|
-
|
(3,284,432 | ) | (3,284,432 | ) | ||||||||||||||||
Balance
at June 30, 2006 (
as restated )
|
108,878,425
|
$ |
108,878
|
$ |
4,480,035
|
$ | (20 | ) | $ | (3,350,437 | ) | $ |
1,238,456
|
|||||||||||
Shares
issued for interest on debentures, July 31, 2006
|
5,744
|
6
|
7,638
|
-
|
-
|
7,644
|
||||||||||||||||||
Shares
issued in connection with conversion of convertible debentures,
July 31, 2006
|
3,333,333
|
3,333
|
996,667
|
-
|
-
|
1,000,000
|
||||||||||||||||||
Exercise
of stock warrants, July 31, 2006
|
200,000
|
200
|
49,800
|
-
|
-
|
50,000
|
||||||||||||||||||
Warrants
issued to Scientific Advisory Board on August 15,
2006
|
-
|
-
|
30,184
|
-
|
-
|
30,184
|
Common
Stock
|
||||||||||||||||||||||||
Additional
|
Stock
|
Total
|
||||||||||||||||||||||
Number
|
Par
|
Paid-in
|
Subscription
|
Accumulated
|
Stockholders'
|
|||||||||||||||||||
Of
Shares
|
Value
|
Capital
|
Receivable
|
Deficit
|
Equity
|
|||||||||||||||||||
Warrants
issued to Scientific Advisory Board on November 15,
2006
|
-
|
-
|
25,888 |
-
|
-
|
25,888 | ||||||||||||||||||
Shares
issued for consulting and legal services rendered at $.76 per share,
January 2, 2007
|
216,000 | 216 | 163,944 |
-
|
-
|
164,160 | ||||||||||||||||||
Warrants
s issued to Scientific Advisory Board on February 15,
2007
|
-
|
-
|
32,668 |
-
|
-
|
32,668 | ||||||||||||||||||
Warrants
issued to Scientific Advisory Board on May 15, 2007
|
-
|
-
|
25,664
|
-
|
-
|
25,664
|
||||||||||||||||||
Shares
issued for consulting services rendered at $1.03 per share, June 12,
2007
|
752
|
1 | 774 |
-
|
-
|
775 | ||||||||||||||||||
Shares
issued for consulting services rendered at $1.15 per share, June 20,
2007
|
100,000
|
100
|
114,900
|
-
|
-
|
115,000
|
||||||||||||||||||
Shares
issued upon conversion of convertible warrants at $1.00 per
share, June 20, 2007
|
930,000
|
930
|
619,070
|
-
|
-
|
620,000
|
||||||||||||||||||
Shares
issued upon conversion of convertible warrants at $1.00 per
share, June 25, 2007
|
75,000
|
75
|
49,925
|
-
|
-
|
50,000
|
||||||||||||||||||
Shares
issued upon conversion of convertible warrants at $1.00 per
share, June 30, 2007
|
300,000
|
300
|
199,700
|
-
|
-
|
200,000
|
||||||||||||||||||
Shares
issued for consulting and legal services rendered at $1.06 per
share,
June 30, 2007
|
29,890
|
30
|
31,770
|
-
|
-
|
31,800
|
||||||||||||||||||
Options
issued to officers June 30, 2007
|
-
|
-
|
27,062
|
-
|
-
|
27,062
|
||||||||||||||||||
Net
loss year ended June 30, 2007.
|
-
|
-
|
-
|
-
|
(3,118,963 | ) | (3,118,963 | ) | ||||||||||||||||
Balance
at June 30, 2007
|
114,069,144
|
$ |
114,069
|
$ |
6,855,689
|
$ | (20 | ) | $ | (6,469,400 | ) | $ |
500,338
|
Year
Ended
June 30, 2007
|
Year
Ended
June 30, 2006
|
For
the Cumulative
Period
From
May 12, 2005
(Inception) through
June 30, 2007
|
||||||||||
OPERATING
ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (3,118,963 | ) | $ | (3,284,432 | ) | $ | (6,469,400 | ) | |||
Adjustments
to reconcile net loss to net cash used by
operating activities:
|
||||||||||||
Shares
issued for services rendered
|
311,735
|
210,301
|
522,036
|
|||||||||
Options
granted to scientific advisory board
|
114,404
|
130,084
|
244,488
|
|||||||||
Amortization
of deferred compensation
|
27,062
|
87,318
|
114,380
|
|||||||||
Depreciation
and amortization
|
2,525
|
94
|
2,619
|
|||||||||
Amortization
of deferred financing expenses
|
6,714
|
44,461
|
51,175
|
|||||||||
Non
cash interest on convertible debentures
|
7,644
|
66,286
|
73,930
|
|||||||||
Non
cash interest expense on beneficial conversion feature of convertible
debentures
|
82,918
|
630,161
|
713,079
|
|||||||||
Changes
in assets and liabilities:
|
||||||||||||
Prepaids
– related parties
|
(22,994 | ) | (213,728 | ) | (236,722 | ) | ||||||
Other
current assets
|
(20,000 | ) |
-
|
(20,000 | ) | |||||||
Deferred
expenses
|
-
|
(2,175 | ) | (2,175 | ) | |||||||
Accounts
payable
|
28,769
|
33,902
|
72,845
|
|||||||||
Accounts
payable –related parties
|
58,993
|
164,738
|
262,038
|
|||||||||
Accrued
expenses
|
(25,831 | ) |
73,307
|
65,000
|
||||||||
Accrued
payroll to officers and related payroll tax
expense
|
217,718
|
232,282
|
450,000
|
|||||||||
Other
payroll taxes payable
|
(3,826 | ) |
3,826
|
-
|
||||||||
|
||||||||||||
Net
cash used in operating activities
|
(2,333,132 | ) | (1,823,575 | ) | (4,156,707 | ) | ||||||
|
||||||||||||
INVESTING
ACTIVITIES:
|
||||||||||||
Secuity
deposit
|
(100,000 | ) | - | (100,000 | ) | |||||||
Purchases
of property and equipment
|
(18,586 | ) | (2,148 | ) | (20,734 | ) | ||||||
Purchase
of Trademark
|
(7,587 | ) |
-
|
(7,587 | ) |
Year
Ended
June
30, 2007
|
Year
Ended
June
30, 2006
|
For
the Cumulative Period From
May 12, 2005 (Inception) through
June 30, 2007
|
||||||||||
Net
cash used in investing activities
|
(126,173 | ) | (2,148 | ) |
(128,321
|
) | ||||||
FINANCING
ACTIVITIES:
|
||||||||||||
Proceeds
from issuance of convertible debentures
|
-
|
1,000,000
|
1,000,000
|
|||||||||
Proceeds
from issuance of common stock and warrants in connection with private
placements of common stock
|
-
|
3,245,000
|
3,245,000
|
|||||||||
Proceeds
from stock option exercise
|
-
|
90,000
|
90,000
|
|||||||||
Payment
of legal expenses related to private placement
|
-
|
(2,175 | ) |
(2,175
|
) | |||||||
Proceeds
from exercise of warrants
|
920,0000
|
-
|
920,000
|
|||||||||
|
||||||||||||
|
||||||||||||
Net
cash provided by financing activities
|
920,000
|
4,332,825
|
5,252,825
|
|||||||||
|
||||||||||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
(1,539,305 | ) |
2,507,102
|
967,797
|
||||||||
|
||||||||||||
CASH
AND CASH EQUIVALENTS, BEGINNING
|
2,507,102
|
-
|
-
|
|||||||||
|
||||||||||||
|
||||||||||||
CASH
AND CASH EQUIVALENTS, ENDING
|
$ |
967,797
|
$ |
2,507,102
|
$ |
967,797
|
||||||
CASH
PAID DURING THE YEAR FOR:
|
||||||||||||
INTEREST
|
$ |
-
|
$ |
-
|
$ |
-
|
||||||
INCOME
TAXES
|
$ |
2,067
|
$ |
--
|
$ |
2,067
|
||||||
|
||||||||||||
CASH
AND CASH EQUIVALENTS, ENDING
|
|
Year Ended June 30,
|
||||||||||||
2007
|
2006
|
For
the Cumulative Period From
May 12, 2005 (Inception) through
June 30, 2007
|
||||||||||
Common
stock issued for services rendered
|
$ |
311,735
|
$ |
210,301
|
$ |
522,036
|
||||||
Stock
options issued to the officers as compensation
|
27,062
|
87,318
|
114,380
|
|||||||||
Stock
warrants granted to scientific advisory board
|
114,404
|
130,084
|
244,488
|
|||||||||
Common
stock issued for interest on debentures
|
7,644
|
66,286
|
73,930
|
|||||||||
Shares
of common stock issued in connection with debenture
offering
|
-
|
49,000
|
49,000
|
|||||||||
Warrants
issued in connection with private placement
|
-
|
1,262,632
|
1,262,632
|
|||||||||
Common
stock issued upon conversion of convertible debentures
|
1,000,000
|
-
|
1,000,000
|
|||||||||
Debt
discount related to beneficial conversion feature of convertible
debt
|
-
|
713,079
|
713,079
|
|||||||||
Warrants
issued in connection with private placement
|
-
|
1,262,632
|
1,262,632
|
A.
|
Accounting
Basis– The
Company has not earned any revenue from limited principal operations.
Accordingly, the Company's activities have been accounted for as
those of
a "Development Stage Company" as set forth in Financial Accounting
Standards Board Statement No. 7 (“SFAS 7"). Among the disclosures required
by SFAS 7 are that the Company's financial statements be identified
as
those of a development stage company, and that the statements of
earnings,
retained earnings and stockholders' equity and cash flows disclose
activity since the date of the Company's
inception.
|
B.
|
Cash
and Cash
Equivalents– The Company considers highly liquid debt instruments
with original maturities of three months or less to be cash equivalents.
In addition, the Company maintains cash and cash equivalents at financial
institutions, which may exceed federally insured amounts at
times.
|
C.
|
Equipment–
Equipment
is
stated at cost and depreciated over the estimated useful lives of
the
assets (generally five years) using the straight-line
method.
|
D.
|
Use
of Estimates– The
preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets
and
liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual
results could differ from those
estimates.
|
E.
|
Research
and
Development– Research and development expenses consist primarily of
costs associated with the preclinical and or clinical trials of drug
candidates, compensation and other expenses for research and development,
personnel, supplies and development materials, costs for consultants
and
related contract research and facility costs. Expenditures relating
to
research and development are expensed as
incurred.
|
F.
|
Accounting
for Stock Based
Compensation– The company adopted the fair value recognition
provisions of “FASB Statement No. 123(R) Share-Based Payment”, using the
modified prospective-transition method. Under that transition method,
compensation cost recognized in the years ended June 30, 2007
and 2006 includes compensation cost for all share-based payment
granted based on the grant-date fair value estimated in accordance
with
provisions of FASB 123(R).
|
Expected
life in years
|
5
years
|
Risk
free interest rate
|
3.88
to 4.10%
|
Expected
volatility
|
108.00
to 109.00%
|
Dividend
yield
|
0%
|
G.
|
Accounting
for Non-Employee
Stock Based Compensation– The Company accounts for shares and
options issued for non-employees in accordance with the provision
of
Emerging Issue Task Force Issue No. 96-18, “Accounting for Equity
Instruments that are issued to other than Employees for Acquiring
or in
Conjunction with selling Goods or Services”. According to the provisions
of ETIF 96-18, the Company determines the fair value of stock and
options
granted to non-employees on the measurement date which is either
the date
of a commitment for performance has been reached or when performance
has
been completed, depending upon the facts and circumstances. The fair
value
of the shares and options valued at commitment date is expensed
immediately if they were for past
services.
|
H.
|
Income
Taxes– The
Company utilizes Statement of Financial Accounting Standards No.
109,
“Accounting for Income Taxes,” which requires an asset and liability
approach to financial accounting and reporting for income taxes.
The
difference between the financial statement and tax basis of assets
and
liabilities is determined annually. Deferred income tax assets and
liabilities are computed for those temporary differences that have
future
tax consequences using the current enacted tax laws and rates that
apply
to the periods in which they are expected to affect taxable income.
Valuation allowances are established, if necessary, to reduce the
deferred
tax asset to the amount that will, more likely than not, be realized.
Income tax expense is the current tax payable or refundable for the
year
plus or minus the net change in the deferred tax assets and
liabilities.
|
I.
|
Basic
Earnings (Loss) per
Share– Basic Earnings (Loss) per Share is calculated in accordance
with SFAS No. 128, "Earnings per Share," by dividing income or loss
attributable to common stockholders by the weighted average common
stock
outstanding. Diluted EPS is calculated in accordance with SFAS No.
128 by
adjusting weighted average common shares outstanding by assuming
conversion of all potentially dilutive shares. In periods where a
net loss
is recorded, no effect is given to potentially dilutive securities,
since
the effect would be antidilutive. Total stock options and warrants
not
included in the calculation of common shares outstanding (including
both
exercisable and nonexercisable) as of June 30, 2007 and 2006 were
4,570,00
and 5,605,000 respectively.
|
|
2007
|
2006
|
||||||
|
|
|
||||||
Net
loss available to common shareholders
|
$ | (3,118,963 | ) | $ | (3,284,432 | ) | ||
|
||||||||
Net
loss per share, basic and diluted
|
$ | (0.03 | ) | $ | (0.03 | ) | ||
|
||||||||
Weighted-average
shares used in computing net loss per share, basic and diluted
|
112,255,669
|
103,591,691
|
J.
|
Concentrations
of Risk–
Financial instruments that potentially subject us to a significant
concentration of credit risk consist primarily of cash and cash
equivalents. The Company maintains deposits in federally insured
institutions in excess of federally insured limits. The Company does
not
believe it is exposed to significant credit risk due to the financial
position of the depository institutions in which those deposits are
held.
|
K.
|
Segment
Reporting– As of
June 30, 2007 the Company has determined that it operates in only
one
segment. Accordingly, no segment disclosures have been included in
the
notes to the consolidated financial
statements.
|
L.
|
New
Accounting Pronouncements
Affecting the Company
|
|
|
2007
|
|
2006
|
|
|||
|
|
|
|
|
|
|||
TheraCour
Pharma, Inc.
|
|
$
|
186,722
|
|
$
|
163,728
|
|
|
Kard
Scientific, Inc.
|
|
|
50,000
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
236,722
|
|
$
|
213,728
|
|
Stock
Options
|
Number
of Shares
|
Weighted
Average Exercise Price per share ($)
|
Weighted
Average Remaining Contractual Term (years)
|
Aggregate
Intrinsic Value ($)
|
||||||||||||
Outstanding
at June 30, 2005
|
3,000,000
|
$ |
0.86
|
2.25
|
$ |
-
|
||||||||||
Granted
|
2,000,000
|
0.10
|
10.00
|
2,980,000
|
||||||||||||
Exercised
|
(1,800,000 | ) |
0.05
|
-
|
-
|
|||||||||||
Expired
|
(1,000,000 | ) |
2.50
|
-
|
-
|
|||||||||||
Canceled
|
(200,000 | ) |
0.05
|
-
|
-
|
|||||||||||
Outstanding
at June 30, 2006
|
2,000,000
|
0.10
|
9.25
|
-
|
||||||||||||
Granted
|
-
|
-
|
-
|
-
|
||||||||||||
Exercised
|
-
|
-
|
-
|
-
|
||||||||||||
Expired
|
-
|
-
|
-
|
-
|
||||||||||||
Canceled
|
(125,00 | ) |
.10
|
-
|
-
|
|||||||||||
Outstanding
at June 30, 2007
|
1,875,000
|
$ |
0.10
|
8.25
|
$ |
1,537,500
|
||||||||||
Exercisable
at June 30, 2007
|
1,416,666
|
$ |
0.10
|
8.25
|
$ |
683,,333
|
Stock
Warrants
|
Number
of Shares
|
Weighted
Average Exercise Price per share ($)
|
Weighted
Average Remaining Contractual Term (years)
|
Aggregate
Intrinsic Value ($)
|
||||||||||||
Outstanding
at June 30, 2005
|
-
|
$ |
-
|
-
|
$ |
-
|
||||||||||
Granted
|
3,605,000
|
1.72
|
2.65
|
-
|
||||||||||||
Exercised
|
-
|
-
|
-
|
-
|
||||||||||||
Expired
|
-
|
-
|
-
|
-
|
||||||||||||
Canceled
|
-
|
-
|
-
|
-
|
||||||||||||
Outstanding
at June 30, 2006
|
3,605,000
|
1.72
|
2.65
|
-
|
||||||||||||
Granted
|
160,000
|
1.35
|
3.50
|
-
|
||||||||||||
Exercised
|
(1,070,000 | ) |
1.21
|
-
|
-
|
|||||||||||
Expired
|
-
|
-
|
-
|
-
|
||||||||||||
Canceled
|
-
|
-
|
-
|
-
|
||||||||||||
Outstanding
at June 30, 2007
|
2,695,000
|
$ |
1.95
|
1.94
|
$ |
-
|
||||||||||
Exercisable
at June 30, 2007
|
2,695,000
|
$ |
1.95
|
1.94
|
$ |
-
|
2007
|
2006
|
|||||||
Net
operating loss carryforwards
|
$ |
1,611,400
|
$ |
710,800
|
||||
Research
and development credit
|
391,700
|
234,000
|
||||||
Other
|
526,300
|
363,700
|
||||||
Gross
deferred tax assets
|
2,529,400
|
1,308,500
|
||||||
Valuation
allowances
|
(2,529,400 | ) | (1,308,500 | ) | ||||
Deferred
tax assets
|
$ |
-
|
$ |
-
|
Year
Ending June
30,
|
||||
2008
|
$ |
140,004
|
||
2009
|
81,669
|
|||
Total
|
$ |
221,673
|
September30,
2007
|
June30,
2007
|
|||||||
Unaudited
|
||||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 2,738,534 | $ | 967,797 | ||||
Prepaid
expenses
|
229,889 | 251,722 | ||||||
Other
current assets
|
5,000 | 5,000 | ||||||
Total
current assets
|
2,973,423 | 1,224,519 | ||||||
Property
and equipment, net
|
17,331 | 18,487 | ||||||
OTHER
ASSETS
|
||||||||
Security
deposit
|
100,000 | 100,000 | ||||||
Trademarks,
net
|
7,089 | 7,215 | ||||||
Total
Other Assets
|
107,089 | 107,215 | ||||||
TOTAL
ASSETS
|
$ | 3,097,843 | $ | 1,350,221 | ||||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable – trade
|
$ | 77,817 | $ | 72,845 | ||||
Accounts
payable – related parties
|
162,958 | 262,038 | ||||||
Accrued
expenses
|
34,753 | 65,000 | ||||||
Accrued
payrollto officers and related payrolltax expense
|
485,352 | 450,000 | ||||||
TOTAL
CURRENT LIABILITIES
|
760,880 | 849,883 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
SHAREHOLDERS’
EQUITY
|
||||||||
Common
stock, $0.001 par value; 300,000,000 shares authorized at September
30,
2007 issued and outstanding: 118,844,388 and 114,069,144 at September
30,
2007 and June 30, 2007 respectively
|
118,844 | 114,069 | ||||||
Additional
paid-in capital
|
9,262,271 | 6,855,689 | ||||||
Stock
subscription receivable
|
(20 | ) | (20 | ) | ||||
Deficit
accumulated during the development stage
|
(7,044,132 | ) | (6,469,400 | ) | ||||
TOTAL
SHAREHOLDERS’ EQUITY
|
2,336,963 | 500,338 | ||||||
TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
$ | 3,097,843 | $ | 1,350,221 |
Three
Months Ended
September
30,
|
For the Cumulative Period From May 12, 2005 (Inception) through September 30, 2007 | ||||||||||
2007
|
2006
|
||||||||||
Revenues
|
$
|
-
|
$
|
-
|
$ |
-
|
|
||||
Operating
expenses:
|
|||||||||||
Research
and development
|
158,814
|
184,885
|
1,821,284
|
|
|||||||
General
and administrative (of this amount $17,957 , $41,884, and $898,861
was for
stock and option based compensation to consultants and officers
for each
period presented)
|
|||||||||||
423,832
|
488,109
|
4,506,127
|
|||||||||
Total
operating expenses
|
582,646
|
672,994
|
6,327,411
|
||||||||
Loss
from operations
|
(582,646
|
)
|
(672,994
|
)
|
(6,327,411
|
) | |||||
Other
income (expense):
|
|||||||||||
Interest
income
|
7,914
|
23,184
|
70,288
|
||||||||
Non
cash interest on convertible debentures
|
-
|
(7,644
|
)
|
(73,930
|
|||||||
Non
cash interest expense on beneficial conversion feature of
convertible debentures
|
-
|
(82,918
|
)
|
(713,079
|
) | ||||||
Total
other income (expense)
|
7,914
|
(67,378
|
)
|
(716,721
|
) | ||||||
Net
loss
|
$
|
(574,732
|
)
|
$
|
(740,372
|
)
|
$ |
(7,044,132
|
)
|
||
Net
loss per share: basic and diluted
|
$
|
(.01
|
)
|
$
|
(.01
|
)
|
|||||
Weighted
average shares outstanding: basic and diluted
|
114,222,270
|
111,224,987
|
Three
Months Ended
September
30,
|
For
the Cumulative Period From May 12, 2005 (Inception) through September
30,
|
|||||||||||
2007
|
2006
|
2007
|
||||||||||
OPERATING
ACTIVITIES:
|
||||||||||||
Net
loss
|
$
|
(574,732
|
)
|
$
|
(740,372
|
)
|
$ |
(7,044,132
|
) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Shares
issued for services rendered
|
18,400
|
-
|
540,436
|
|||||||||
Warrants
granted to scientific advisory board
|
14,800
|
30,184
|
259,288
|
|||||||||
Options
issued to officers as compensation
|
3,157
|
11,700
|
117,537
|
|||||||||
Depreciation
and amortization
|
1,282
|
127
|
3,901
|
|||||||||
Amortization
of deferred financing expenses
|
-
|
6,714
|
51,175
|
|||||||||
Non
cash interest on convertible debentures
|
-
|
7,644
|
73,930
|
|||||||||
Non
cash interest expense on beneficial conversion feature of convertible
debentures
|
-
|
82,918
|
713,079
|
|||||||||
Changes
in assets and liabilities:
|
|
|||||||||||
Prepaid
expenses
|
21,833
|
(76,499
|
)
|
(229,889
|
) | |||||||
Deferred
expenses
|
-
|
-
|
(2,175
|
) | ||||||||
Other current
assets
|
-
|
-
|
(5,000
|
) | ||||||||
Accounts
payable- trade
|
4,972
|
(14,021
|
)
|
77,817
|
||||||||
Accounts
payable –related parties
|
(99,080
|
)
|
(51,432
|
)
|
162,958
|
|||||||
Accrued
expenses
|
(30,247
|
)
|
(17,723
|
)
|
34,753
|
|||||||
Accrued
payroll to officers and related payroll tax expense
|
35,352
|
(15,663
|
)
|
485,352
|
||||||||
Net
cash used in operating activities
|
(604,263
|
)
|
(776,423
|
)
|
(4,760,970
|
) | ||||||
INVESTING
ACTIVITIES:
|
||||||||||||
Security
deposit
|
-
|
-
|
(100,000
|
) | ||||||||
Purchases
of property and equipment
|
-
|
-
|
(20,734
|
) | ||||||||
Purchase
of trademarks
|
-
|
(3,200
|
)
|
(7,587
|
) | |||||||
Net
cash used in investing activities
|
-
|
(3,200
|
)
|
(128,321
|
) | |||||||
FINANCING
ACTIVITIES:
|
||||||||||||
Proceeds
from issuance of convertible debentures
|
-
|
-
|
1,000,000
|
|||||||||
Proceeds
from issuance of common stock and warrants in connection
with private placements of common stock – net of fees
|
2,375,000
|
-
|
5,620,000
|
|||||||||
Proceeds
from exercise of stock warrants attached to convertible
debentures
|
-
|
50,000
|
920,000
|
|||||||||
Payment
of legal fees related to private placement
|
(2,175
|
) | ||||||||||
Proceeds
from exercise of stock options
|
-
|
-
|
90,000
|
|||||||||
Net
cash provided by financing activities
|
2,375,000
|
50,000
|
7,627,825
|
|||||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
1,770,737
|
(729,623
|
)
|
2,738,534
|
||||||||
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
967,797
|
2,507,102
|
-
|
|||||||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
2,738,534
|
$
|
1,777,479
|
$ |
2,738,534
|
Three
Months Ended
September
30,
|
For
the Cumulative Period From
|
|||||||||||
May
12, 2005 (Inception) through
|
||||||||||||
2007
|
2006
|
September
30, 2007
|
||||||||||
Common
stock issued for services rendered
|
$
|
18,400
|
$
|
-
|
$
|
541,436
|
||||||
Stock
options issued to the officers as compensation
|
3,157
|
11,700
|
117,537
|
|||||||||
Stock
warrants granted to scientific advisory board
|
14,800
|
30,184
|
259,288
|
|||||||||
Common
stock issued for interest on debentures
|
-
|
7,644
|
73,930
|
|||||||||
Shares
of common stock issued in connection with debenture
offering
|
-
|
-
|
49,000
|
|||||||||
Common
stock issued upon conversion of convertible debentures
|
-
|
1,000,000
|
1,000,000
|
|||||||||
Debt
discount related to beneficial conversion feature of convertible
debt
|
-
|
-
|
713,079
|
|||||||||
Warrants
issued in connection with private placement
|
-
|
-
|
1,262,632
|
Expected
life in years
|
5
years
|
Risk
free interest rate
|
3.88
to 4.10%
|
Expected
volatility
|
108.00
to 109.00%
|
Dividend
yield
|
0%
|
September
30,
2007
|
June
30,
2007
|
|||||||
TheraCour
Pharma, Inc. *
|
$
|
164,889
|
$
|
186,722
|
||||
Kard
Scientific, Inc. *
|
50,000
|
50,000
|
||||||
Prepaid
other **
|
15,000
|
15,000
|
||||||
$
|
229,889
|
$
|
251,722
|
Expected
life in years
|
4
years
|
Risk
free interest rate
|
4.31%
|
Expected
volatility
|
83%
|
Dividend
yield
|
0%
|
Stock
Options
|
Number
of
Shares
|
Weighted
Average
Exercise
Price
per
share
($)
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
($)
|
||||||||||||
Outstanding
at June 30, 2007
|
1,875,000
|
$
|
0.10
|
8.25
|
$
|
1,280,000
|
||||||||||
Granted
|
-
|
-
|
-
|
-
|
||||||||||||
Exercised
|
-
|
-
|
-
|
-
|
||||||||||||
Expired
|
-
|
-
|
-
|
-
|
||||||||||||
Canceled
|
-
|
-
|
-
|
-
|
||||||||||||
Outstanding
at September 30, 2007
|
1,875,000
|
$
|
0.10
|
8.00
|
$
|
1,200,000
|
||||||||||
Exercisable
at September 30, 2007
|
1,416,666
|
$
|
0.10
|
8.00
|
$
|
906,666
|
Stock
Warrants
|
Number
of
Shares
|
Weighted
Average
Exercise
Price
per
share
($)
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
|||||||||
Outstanding
at June 30, 2007
|
2,695,000
|
$
|
1.95
|
1.94
|
||||||||
Granted
|
1,465,000
|
1.00
|
3.03
|
|||||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Expired
|
-
|
-
|
-
|
|||||||||
Canceled
|
-
|
-
|
-
|
|||||||||
Outstanding
at September 30, 2007
|
4,160,000
|
$
|
1.62
|
2.16
|
||||||||
Exercisable
at September 30, 2007
|
4,160,000
|
$
|
1.62
|
2.16
|
September
30,
2007
|
June
30,
2007
|
|||||||
Net
operating loss carryforwards
|
$
|
1,768,300
|
1,611,400
|
|||||
Research
and development credit
|
473,500
|
391,700
|
||||||
Other
|
538,900
|
526,300
|
||||||
Gross
deferred tax assets
|
2,780,700
|
2,529,400
|
||||||
Valuation
allowances
|
(2,780,700
|
)
|
(2,529,400
|
)
|
||||
Deferred
tax assets
|
$
|
-
|
$
|
-
|