SECURITIES
AND EXCHANGE COMMISSION
Washington,
D. C. 20549
FORM
10-SB/A
Amendment
No. 1
General
Form for Registration of Securities
Pursuant
to Section 12(b) or (g) of
The
Securities Exchange Act of 1934
NANOVIRICIDES,
INC.
(Name
of
small business issuer in our charter)
Nevada
|
8731
|
76-0674577
|
(State
or other jurisdiction of Incorporation or organization)
|
(Primary
Standard Industrial Classification Code Number)
|
(I.R.S.
Employer Identification No.)
|
135
Wood Street, Suite 205
West
Haven, Connecticut 06516
(203)
937-6137
(Address,
including zip code, and telephone number, including area code, of Registrant’s
principal executive offices)
Copies
to:
Peter
Campitiello, Esq.
Levy
& Boonshoft, P.C.
477
Madison Avenue
New
York, New York 10022
(212)
751-1414
Securities
to be registered pursuant to Section 12(b) of the Act:
None
(Title
of
Class)
Securities
to be registered pursuant to Section 12(g) of the Act:
Common
Stock, $.001 par value per share
(Title
of
Class)
NanoViricides,
Inc.
INDEX
TO THE FORM 10-SB
Table
of Contents
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Page
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PART
I
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ITEM
1.
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3
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ITEM
2.
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41
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ITEM
3.
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52
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ITEM
4.
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53
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ITEM
5
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54
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ITEM
6
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56
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ITEM
7
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57
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ITEM
8
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58
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PART
II
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ITEM
1
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61
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ITEM
2
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62
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ITEM
3
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62
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ITEM
4
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62
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ITEM
5
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65
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PART
F/S
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66
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PART
III
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ITEM
1
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101
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SIGNATURES
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PART
I
SPECIAL
NOTE ON FORWARD-LOOKING STATEMENTS
The
information in this report contains forward-looking statements. All statements
other than statements of historical fact made in report are forward looking.
In
particular, the statements herein regarding industry prospects and future
results of operations or financial position are forward-looking statements.
These forward-looking statements can be identified by the use of words such
as
“believes,” “estimates,” “could,” “possibly,” “probably,” anticipates,”
“projects,” “expects,” “may,” “will,” or “should” or other variations or similar
words. No assurances can be given that the future results anticipated by
the
forward-looking statements will be achieved. Forward-looking statements reflect
management’s current expectations and are inherently uncertain. Our actual
results may differ significantly from management’s expectations.
The
following discussion and analysis should be read in conjunction with our
financial statements, included herewith. This discussion should not be construed
to imply that the results discussed herein will necessarily continue into
the
future, or that any conclusion reached herein will necessarily be indicative
of
actual operating results in the future. Such discussion represents only the
best
present assessment of our management.
ITEM
I: DESCRIPTION OF BUSINESS
Corporate
History
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25,
2000
as Edot-com.com, Inc
.
and
was
organized for the purpose of conducting internet retail sales. On April 1,
2005,
Edot-com.com, Inc.
was
incorporated under the laws of the State of Nevada for the purpose of
re-domiciling the Company as a Nevada corporation, Edot-com.com (Nevada).
On
April 15, 2005, Edot-com.com (Colorado) and Edot-com.com (Nevada) were merged
and Edot-com.com, Inc., (ECMM)
a
Nevada
corporation, became the surviving entity.
On
April
15, 2005, the authorized shares of
common
stock was increased to 300,000,000 shares at $.001 par value and the Company
effected a 3.2 - 1 forward stock split effective May 12, 2005.
On
June
1, 2005, Edot-com.com, Inc. acquired NanoViricide, Inc., a privately owned
Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share Exchange
(the “Exchange”). NVI was incorporated under the laws of the State of Florida on
May 12, 2005 and its sole asset was comprised of a licensing agreement with
TheraCour Pharma, Inc. (an approximately 31% shareholder of NVI) for rights
to
develop and commercialize novel and specifically targeted drugs based on
TheraCour's targeting technologies, against a number of human viral diseases.
(For financial accounting purposes, the acquisition was a reverse acquisition
of
the Company by NVI, under the purchase method of accounting, and was treated
as
a recapitalization with NVI as the acquirer.) Upon consummation of the Exchange,
ECMM adopted the business plan of NVI.
Pursuant
to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate
of
80,000,000 newly issued shares of ECMM common stock, resulting in an aggregate
of 100,000,000 shares of ECMM common stock issued and outstanding. As a result
of the Exchange, NVI became a wholly-owned subsidiary of ECMM. The ECMM shares
were issued to the NVI Shareholders on a pro rata basis, on the basis of
4,000
shares of the Company’s Common Stock for each share of NVI common stock held by
such NVI Shareholder at the time of the Exchange.
On
June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, Edot-com.com, Inc.,
Inc.
changed its name to NanoViricides, Inc. and its stock symbol on the Pink
Sheets
to “NNVC”, respectively. The Company is considered a development stage company
at this time.
NanoViricides,
Inc. (the “Company”), is an early developmental stage nano-biopharmaceutical
company engaged in the discovery, development and commercialization of
anti-viral therapeutics. The Company has no customers, products or revenues
to
date, and may never achieve revenues or profitable operations. Our drugs
are
based on several patents, patent applications, provisional patent applications,
and other proprietary intellectual property held by TheraCour Pharma, Inc.,
one
of the Company’s principal shareholders, to which we have the licenses in
perpetuity for the treatment of the following human viral diseases: Human
Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus
(HCV), Herpes Simplex Virus (HSV), Rabies, Influenza and Asian Bird Flu Virus.
We focus our laboratory research and pre-clinical programs on specific
anti-viral solutions. We are seeking to add to our existing portfolio of
products through our internal discovery pre-clinical development programs
and
through an in-licensing strategy.
The
Company has incurred significant operating losses since its inception resulting
in an accumulated deficit of $4,090,809 at September 30, 2006. For the three
months ended September 30, 2006 the Company had a net loss of $ 740,372.
Such
losses are expected to continue for the foreseeable future and until such
time,
if ever, as the Company is able to attain sales levels sufficient to support
its
operations.
The
accompanying financial statements on pages of this Form 10-SB have been prepared
assuming that the Company will continue as a going concern which contemplates
the realization of assets and the satisfaction of liabilities in the normal
course of business. Accordingly, they do not include any adjustments relating
to
the realization of the carrying value of assets or the amounts and
classification of liabilities that might be necessary should the company
be
unable to continue as a going concern. The Company's significant operating
losses and significant capital requirements, however, raise substantial doubt
about the Company's ability to continue as a going concern. The Company’s
auditors have issued a going concern qualification as part of their
opinion.
Glossary
of Terms:
Nano
-
When
used as a prefix for something other than a unit of measure, as in
"nanoscience", nano means relating to
nanotechnology
,
or on a
scale of nanometers (one billionth of a meter or greater)
Viricide-
is
an
agent which reliably deactivates or destroys a virus.
Ligand
-
is a
short peptide (chemical) molecule that has been designed to specifically
recognize one particular type of virus.
Micelle
-
One of
the structural units said to make up organized bodies
Nanomicelle
-
micelles on the scale of nanometers
Pendant
polymeric micelles
-
A
polymicelle is a polymer whose chemical constitution is such that even a
single
chain of the polymer forms a micelle. A pendant polymer is a polymer which
has
certain units in its backbone that extend short chains branched away from
the
backbone. Pendant Polymeric Micelles therefore are polymeric micelle materials
that are a class of pendant polymers.
Mutants
-
The
ability (of the virus) to change its genetic structure to avoid the body’s
natural defenses.
The
NanoViricide Concept
The
Company owns an exclusive worldwide license in perpetuity to technology that
enables the creation of nanoviricides (tm). A “nanoviricide” is a flexible
nano-scale material approximately a few billionths of a meter in size, which
is
chemically programmed by a “ligand” to specifically target and attack a
particular type of virus. A nanoviricide also is capable of simultaneously
delivering a devastating payload of active pharmaceutical ingredients (API)
into
the virus particle, to destroy the genome (RNA/DNA).
Background:
The NanoViricides Technology and Approach
The
NanoViricides Technology and Approach
Nanoviricide
drugs, which are presently in an early stage of development, are designed
to
lead to reduction in viremia by a set of multiple concerted mechanisms:
|
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 probably
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 (such as Doxil™) (see
http://www.nci.nih.gov
).
Our goal, which can give no assurance that we will achieve, is
for
NanoViricides, Inc. to be the first company to bring this feature
to the
anti-viral therapy platform.
|
|
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.
|
We
designed the nanoviricides to act by completely novel and distinctly different
mechanisms compared to most existing anti-viral agents. The self-assembling
nanoviricide “trojan horses” would be expected to course through the blood
stream, seek their target, i.e. a specific virus particle, attach themselves
to
the virus particle target and fuse with the virus particle. This chain of
events, if it in fact occurs, is designed to destroy the virus particle's
ability to infect host cells. In addition, if the nanoviricide contains an
encapsulated API, such API may be deployed into the virus particle and might
lead to destruction of the virus genetic material (such as viral DNA, viral
RNA,
etc.), and/or key viral components that the virus carries inside its “belly”
(such as the reverse transcriptase, the protease, and the integrase carried
by
HIV particles), based on the capabilities of the API. This concept needs
to be
extensively tested in future experiments. The concept of targeted delivery
of an
API is well known in the cancer therapeutics arena as this quote from the
National Cancer Institute website above makes clear “Nanoscale devices have the
potential to radically change cancer therapy for the better and to dramatically
increase the number of highly effective therapeutic agents. Nanoscale constructs
can serve as customizable, targeted drug delivery vehicles capable of ferrying
large doses of chemotherapeutic agents or therapeutic genes into malignant
cells
while sparing healthy cells, greatly reducing or eliminating the often
unpalatable side effects that accompany many current cancer therapies.”
http://nano.cancer.gov/resource_center/nano_critical.asp
- cancer
.
We
designed the nanoviricides to act by a novel set of multiple,
concerted
,
mechanisms. However, being so novel, our drugs are not directly comparable
to
existing anti-viral therapies. Thus, the safety and efficacy of the
nanoviricides needs to be established by experimentation, and cannot be
anticipated on the basis of any similar information regarding existing drugs.
See
Part
I
,
Preclinical
Safety And Efficacy Studies.
It
is
important that the flexible nanoviricides nanomedicines show substantial
advantages over hard sphere nanoparticles in this antiviral drug application.
Hard sphere nanomaterials such as dendritic materials, nanogold shells, silica,
gold or titanium nanospheres, polymeric particles, etc., were never designed
to
be capable of completely enveloping and neutralizing the virus particle.
The
Company does not claim to be creating a cure for viral diseases. The Company's
objectives are to create the best possible anti-viral nanoviricides and then
subject these compounds to rigorous laboratory and animal testing. Our long-term
research efforts are aimed at augmenting the nanoviricides that we currently
have in development with additional therapeutic agents
The
Company plans to develop several drugs through the preclinical studies and
clinical trial phases with the goal of eventually obtaining approval from
the
United States Food and Drug Administration (“FDA”) for these drugs. The Company
also plans, when appropriate, to seek regulatory approvals in several
international markets, including developed markets such as Europe, Japan,
Australia, and underdeveloped regions such as Southeast Asia, India, China,
and
the African subcontinent. The seeking of these regulatory approvals would
only
come when and if one or more of our drugs, now in very early stage of
pre-clinical development, has significantly advanced through the US FDA
regulatory process. If these advances occur, the Company may attempt to partner
with more established pharmaceutical companies to advance the various drugs
through the approval process.
There
can
be no assurance that the Company will be able to develop effective
nanoviricides, or if developed, that we will have sufficient resources to
be
able to successfully manufacture and market these products to commence
revenue-generating operations.
The
Company's headquarters are currently in West Haven, Connecticut.
Our
Product Focus and Technologies
The
Company plans to develop several different nanoviricide drugs against a number
of human viral diseases. The Company has a license in perpetuity to develop
drugs based on technologies originally created by TheraCour Pharma, Inc.,
against the following human viral diseases: H5N1 (Avian Flu), Human Influenza,
Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis
C
Virus (HCV), Herpes Simplex Virus (HSV), and Rabies, including all known
strains
of these viruses.
We
currently have, in early, active development, products against H5N1 (Avian
Flu),
common Human Influenza (both highly pathogenic and non pathogenic), Rabies,
and
Hepatitis C. We plan on undertaking the development of drugs against other
viruses when adequate financing becomes available. The Company's ability
to
achieve progress in the drugs in development is dependent upon available
financing and upon the Company's ability to raise capital.
Background:
Preclinical Safety And Efficacy Studies
The
discussions in this section and throughout this Form 10-SB registration
statement describe the tests that have been conducted which have yielded
these
results. These results do not provide enough evidence regarding efficacy
or
safety to support an application with the FDA. Additional tests will need
to be
conducted. It must be noted that subsequent results often do not corroborate
earlier results.
Preliminary
Safety Studies In Vitro
We
have
conducted limited initial animal safety studies on one of the core TheraCour™
nanomaterials (patent pending). TheraCour technology covers a large range
of
nanomaterials in a class known as pendant polymeric micelles. These materials
are self-assembling, flexible, non-particulate, and stable at room temperature.
We
rely
upon TheraCour nanomaterial to form the backbone of our nanoviricide antiviral
drugs. One of the TheraCour polymers was tested at a 100mg/kgBW (body-weight)
dose level in mice in a preliminary experiment. In studies involving gross
tissue examination, microscopic histology studies, and blood pathology, no
ill-effects or toxic effects were found. These studies showed that the tested
core nanomaterial did not cause any organic damage in mice at the amounts
tested. All results were within safe limits.
Higher
dosage levels and studies on additional materials are planned in order to
determine the safety thresholds in laboratory animals. The only purpose of
these
studies was to give our scientists direction in designing the next set of
studies. These have no impact on the regulatory (FDA) process.
Proof-of
Principle
We
have
conducted studies which
demonstrated
that when a small chemical molecule (ligand) is attached to our nanomicelles
covalently, the resulting nanoviricide has such a high activity that as little
as 1/50
th
of
the
attached molecule is needed for comparable activity [i.e. A 20mg/kgBW injection
of free molecule and a 0.04 mg/kgBW injection of the molecule attached to
the
polymer showed equivalent efficacy.]. These results suggest to us that the
observed antiviral activity of the nanoviricide is due to the proposed mechanism
of action of the nanoviricide and not to either component of the drug, the
ligand or the nanomicelle. This is considered "proof of principle" in that
our
original theoretical assumptions about the functionality of the nanoviricide
have scientifically been validated.
Preliminary
Efficacy Study
A
nanoviricide drug was made using a well-known compound that has known efficacy
against common influenza. This nanoviricide and the free compound were tested
along with appropriate controls in mice infected with very high levels of
a
common influenza virus called H1N1. The results indicated that the efficacy
of
the nanoviricide was approximately 50 Times (5,000%) better than that of
the
free compound.
This
study indicated that the efficacy of a known virus-binding compound can be
enhanced to extremely high levels by using the nanoviricides technology.
We had
predicted such strong efficacy improvements theoretically. Further work will
be
necessary to substantiate that such an effect is seen across a wide range
of
compounds.
Preliminary
Cell Culture Studies Against H5N1 Avian Influenza
As
a test
case, we have developed and evaluated the safety and efficacy of nanoviricides
against common influenza and H5N1, one of the highly pathogenic avian influenzas
which the World Health Organization feels is a potential pandemic threat.
In
vitro (laboratory) evaluation of 14 substances, including controls, was
performed to evaluate protection of mammalian cells against infection by
the
H5N1 subtype. These assays were conducted in Vietnam under the auspices of
the
National Institute of Hygiene and Epidemiology, Hanoi (NIHE) under the Vietnam
Ministry of Health. We identified four different nanoviricides as being highly
effective against H5N1 using two different assays, both involving cell culture,
one using the plaque reduction method and the other involving microscopic
examination, to determine the extent of cytopathic events (CPE) reduction.
All
of these nanoviricides were effective at extremely low concentrations and
many
of them are considered by us to be drug candidates.
The
most
successful of these was a nanoviricide based on an antibody fragment as the
targeting ligand, which led to substantial suppression of CPE at an
extraordinarily low concentration level. This is being developed as
AviFluCide-I™, a drug highly specific to H5N1 that is being developed against
the Vietnam strain.
Another
nanoviricide which is based on a ligand that we designed in-house to be specific
to the group of all or a majority of highly pathogenic avian influenza (HPAI)
viruses, also showed a very high efficacy. This is being developed as
“AviFluCide-HP™”, a drug designed to be group-specific against emergent and
existing highly pathogenic influenza viruses (including H5N1, H7N3 and others).
Non-H5N1 HPAI (non-pathogenic avian influenza) strains could also become
a
pandemic threat as can all influenza A viruses since they all have the ability
to mutate. It is well known that influenza strains drift constantly due to
mutation, ressortment or recombination events leading to failure of vaccines.
Preliminary
analysis of the H5N1 preclinical in vitro studies completed in Vietnam showed
that many nanoviricide™ candidates were effective at as low as 5-nanomolar
concentration levels in cell culture experiments. Typically, an early
developmental drug that proves effective at concentrations less than 500
nanomolars is considered a strong candidate for FDA approval as an
“Investigational New Drug (IND)” applicant.
A
third
nanoviricide is based on a ligand that we designed for attacking all influenza
A
viruses (type-level specificity) has shown strong efficacy against H5N1 as
well.
This is being developed as “FluCide-I™”, a drug designed primarily for use
against serious cases of human influenza.
Preliminary
Efficacy Studies In Vivo
All
but
the antibody-based anti-influenza nanoviricides have been recently tested
in
mice in an aggressive study involving extremely high levels of infection
with a
common influenza strain called H1N1. This study was conducted by Dr. Krishna
Menon, the Company’s Chief Regulatory Officer. While a final comprehensive
report on this study has not yet been issued, the results indicate that most
of
the nanoviricide nanotechnology-based drug candidates were more efficacious
than
oseltamivir (Tamiflu(tm)). Initial unpublished data suggest that FluCide-I
may
be as much as 10 times (1,000%) superior to Tamiflu in common influenza.
From
this
unpublished data, we have concluded that the results are statistically
significant with a p<0.003. However, it must be stressed that these results
were very preliminary and similar results may not be found on retesting.
For a
detailed discussion of the significance of the p value, please see
http://en.wikipedia.org/wiki/P-value
.
However, further repeat studies will be necessary to substantiate and validate
these results.
Current
pharmaceutical industry work in antiviral therapy generally results in small
efficacy improvements. Thus, in the case of influenza, recently peramivir™,
(BioCryst) was reported as having approximately equal efficacy to oseltamivir
(Tamiflu, Roche). However, it was suggested that peramivir™ may have a superior
safety profile and thus may enable use of large does.
It
should
be noted that all of our studies to date were preliminary. Thus, the evidence
we
have developed is indicative, but not considered confirmative, of the
capabilities of the nanoviricides technology's potential. These results merely
lead us to the next step in the research process. They have no relevance
when it
comes to the FDA regulatory process. Despite such excellent early results,
there
is a risk that the nanoviricides may not result in commercializable drugs.
(
See
Part
I
,
Government
Regulation)
Background:
Collaborations and Subcontract Arrangements
Arrangement
with KARD Scientific, Inc.
Owned
and
operated by Dr. Krishna Menon, KARD Scientific Inc. of Wilmington,
Massachusetts, is currently our primary vendor for animal model study design
and
performance. KARD operates its own facilities in Wilmington, Massachusetts.
KARD
uses the Beth Israel Deaconess Hospital of the Harvard University Medical
School
to conduct these studies on our behalf. NanoViricides, Inc. does not have
any
direct collaborative relationships with Beth Israel Deaconess or Harvard
University.
NanoViricides
has a fee for service arrangement with KARD. We do not have an exclusive
arrangement with KARD; we do not have a contract with KARD; and all work
performed by KARD must have prior approval by the executive officers of
NanoViricides.
Dr.
Krishna Menon is the Company’s Chief Regulatory Officer, a non-executive officer
position.
Collaboration
with the Health Ministry of the Government of Vietnam
On
December 23, 2005, the Company signed a Memorandum of Understanding with
the
National Institute of Hygiene and Epidemiology in Hanoi (NIHE), a unit of
the
Vietnamese Government’s Ministry of Health. This Memorandum of Understanding
calls for cooperation in the development and testing of certain nanoviricides.
The parties agreed that the initial target would be the development of drugs
against H5N1 (avian influenza). NIHE thereafter requested that we develop
a drug
for rabies, a request to which we agreed. The initial phase of this agreement
called first for laboratory testing, followed by animal testing of several
drug
candidates developed by the Company. Preliminary laboratory testing of
FluCide™-I, AviFluCide-I™ and AviFluCide-HP™ were successfully performed at the
laboratories of the National Institute of Hygiene and Epidemiology in Hanoi
(NIHE). The second phase of the project, animal testing of the Influenza
and
H5N1 candidates as well as that of RabiCide-I™, the company’s rabies drug, is
expected to commence during the first quarter of 2007. The H5N1 testing will
utilize the NIHE’s BSL3 (biological safety laboratory level 3) laboratory that
is at the NIHE. Rabies testing can safely be done at their BSL2 facility.
A copy
of the Memorandum of Understanding is attached as an Exhibit to this Form
10-SB/A.
Other
Collaborations
The
Nanoviricides approach depends upon significant scientific input as well
as
scientific experimentation during various stages of developments. The Company
currently does not have the facilities to conduct most of the anti-viral
studies. The Company will need to develop additional collaborations in order
to
minimize capital outlays.
We
have
made significant efforts in the past year and continue to do so to obtain
collaborations with various agencies, institutions, and commercial enterprises.
However at this time we cannot be certain that these efforts will eventually
materialize into formal agreements.
It
should
be noted that while the nanomaterials and nanomedicines we are developing
are
designed with the above set of ground rules, it is generally not possible
to
establish whether each of these mechanisms is actually active or whether
it is
truly responsible for the efficacy observed.
We
believe that mechanisms are guidelines rather than endpoints. Our study
endpoints and development programs are defined for establishing efficacy,
safety, and chemical manufacturing controls, rather than establishing mechanisms
of action.
Escape
Mutants
Escape
mutants are a known risk and challenge to any given anti-viral drug. Our
plan is
to develop new drugs with modified ligands that attack the new attachment
sites
of the escape mutants. The rationale for this is based on the concept that
a
nanoviricide drug is constructed from several building blocks. One of these
building blocks is the ligand that attaches specifically to the virus.
Identifying or creating a new ligand that binds to an escape mutant enables
creating a new drug, simply by replacing the ligand part of a drug already
known
to be reasonably safe and efficacious. The Company's scientists have developed
strategies for identifying and designing such ligands.
Ligand
Tuning(tm)
A
very
broad-spectrum nanoviricide can be made by using a ligand that binds to a
very
large number of types and strains of a given virus. Usually, but not always,
it
is possible to identify a ligand that will provide such a broad specificity
against a particular virus.
Usually,
the broader the spectrum of a ligand, the lower is its efficacy level by
itself.
Thus, it is always beneficial to develop highly efficacious narrow spectrum
drugs against potentially deadly diseases.
Background:
Bio-Defense - Emergency Preparedness
NanoViricides
Technology May be Well Suited for Bio-Terrorism and Emerging Disease Threat
Response
In
our
early stages of development, we have designed a building-block based approach
of
nanoviricides drug development which may have potential use against
bio-terrorism, accidental release of infectious agents, or natural outbreaks.
This building block approach might have the potential to allow us to
expeditiously develop a new drug to fight new and emerging threats. The Company
has shown this in a presentation to the U. S. Department of
Defense.
Background:
Bio-Defense “Rapid threat Response”
One
of
the long-term goals of the Company is to develop the ability to assist in
the
response of governments to viral bio-threats, whether due to bio-terrorism
or
natural events. Such a response scenario may in fact be possible because
of the
building-block nature of the nanoviricides platform technology. In this
scenario, a base nanoviricide would be stockpiled under strategic national
and
international stockpiling programs, and a new drug could be developed against
a
threat even prior to identifying the actual pathogen that is the cause of
the
public health crisis event. This capability is seen as extremely valuable
because it is anticipated that bioterrorism agents of the future as well
as
natural outbreaks may be of novel pathogens and therefore identification
and
diagnosis of the same may take large amounts of time, a time period in which
an
epidemic may threaten to become a pandemic. Such was the case with SARS,
and
other smaller outbreaks. A recent coxsackie virus outbreak in Northern India
resulted in several child fatalities during the pathogen identification time
frame itself, despite being caused by a previously known pathogen.
Background:
Anti-HIV Drugs
Importance
of Reduction in Viremia
In
the
field of HIV treatment, it is well established that keeping the viremia to
a
minimum level has significant clinical benefits. Thus, in one clinical study,
only 8% of HIV infected patients with a viral load of less than 4350 copies
of
viral mRNA/uL progressed to full-blown AIDS in 5 years. By contrast, 62%
of
patients with a viral load of greater than 36,270 copies of mRNA/uL had
developed AIDS in the same period (ref 145 from PATH p254). Viremia is
significantly controlled with the current state of the art
highly
active antiretroviral
therapies (HAART) against HIV, to the extent of almost undetectable viral
load
(i.e. less than 50-75 copies of HIV RNA per ml) in many patients. However,
this
is a dynamic condition, in which the rate of creation of new virus particles
is
balanced by the rate of their destruction, primarily by the body's innate
defenses. In addition, once an escape mutation occurs, the HAART therapy
loses
its effectiveness and viral load rises sharply. Similarly, other precipitative
events such as a secondary infection can cause progress to the AIDS stage.
The
AIDS stage is characterized by rapidly rising HIV viral loads (viremia),
and,
concomitantly, rapidly declining CD4+ T cells (an important component of
human
immune system). Eventually, the patient dies of complications related to
the
debilitation of immune response, often by a variety of secondary infections
or
even neoplasms (cancers) that grow unchecked.
In
the
very first stage of HIV infection, i.e. immediately after infection, there
is a
rapid rise in HIV viremia in the first few weeks, called the Acute HIV Syndrome
(or Disease). If the body's immune system then brings the viremia under control,
into a dynamic state, it called “Asymptomatic HIV Disease”. This stage lasts for
a median 10 years, and a precipitative event, such as usually a secondary
infection, leads to the clinical manifestations of AIDS. During the asymptomatic
stage, it is known that the level of the steady state viremia correlates
with
the future progression of the disease and the life span of the patient.
While
HAART therapy, when successful, leads to “undetectable” levels of viremia, the
virus levels may still be at about 50 copies per ml, or about 1.5 million
circulating
virions
in the blood and probably many magnitudes more virions inside cells and other
tissues. This is still a very large load of virus. Thus, control of viremia
is
important even in the asymptomatic stage of “latent” HIV infection, even with
HAART therapy.
Based
on
our early stage in-vitro and in-vivo results on our anti-viral influenza
nanoviricides, we now have a scientific basis to expect that once we identify
and attach a suitable ligand to develop an anti-HIV nanoviricide, it may
well be
possible to control viremia in all three stages of the HIV disease; viz.
the
early acute HIV infection syndrome, the later clinically latent HIV infection,
and the late stage of full-blown AIDS. This “system” still needs to be
extensively tested in the laboratory and in animals before any definitive
statements can be made about its effectiveness.
The
Company's Plan of Attacking HIV/AIDS
The
Company has initiated the development process for two drugs against HIV,
called
HiviCide-I and HiviCide-II respectively. These two drugs together are expected
to encompass the currently known array of HIV types and subtypes in the world.
These first nanoviricides drugs have been designed to engulf the virus
particles, and dismantle them. We do not anticipate starting to begin basic
testing of these initial candidates until late 2007. This depends on adequate
financing for the staff as well as for the materials necessary to begin the
evaluation process.
HIV
is an
extremely difficult, if not impossible virus to eradicate. The HIV genome
copies
itself ("integrates") into the human cellular DNA. This integration process
makes HIV almost immortal. This drug development objective is to be able
to
reduce viral load. Whether or not that is possible with this virus is not
yet
known and the concept will have to be extensively tested.
Background:
Influenza
Seasonal
Influenza.
Seasonal
influenza, commonly known as the flu, is a viral infection characterized
by
symptoms including fever, cough, sore throat, fatigue, headache, and/or chills.
According to the U.S. Centers for Disease Control and Prevention (“CDC”),
(
www.cdc.gov
),
an
estimated 5% to 20% of the American population suffers from influenza annually,
more than 200,000 people are hospitalized from flu complications, and
approximately 36,000 people die from the flu in the US. The worldwide death
toll
is estimated at upwards of 200,000 per year. Influenza is particularly dangerous
to the elderly, young children and people with certain chronic health
conditions. Outbreaks of seasonal flu tend to follow predictable patterns
usually occurring in the winter. New vaccines are developed annually based
on
known flu strains and are usually available for the annual flu season. There
are
also antiviral treatments available for the treatment of people infected
with
the influenza virus.
Avian
Influenza.
According
to information taken from the CDC website, avian influenza, or bird flu,
is an
infection caused by viruses which occur naturally among birds. This form
of flu
is very contagious among birds and can lead to serious illness and sometimes
death. There are two main forms of disease that infect domestic poultry,
one a
low pathogenic form and the other a highly pathogenic form. The latter form
can
cause disease that affects multiple internal organs and with a mortality
rate
between 90-100% in these birds within 2 days.
While
there are many different subtypes of the influenza A viruses, only three
subtypes are known to be currently circulating among humans. Avian influenza
A
viruses are found chiefly in birds, but there have been confirmed cases of
infection in humans, generally as a result of contact with infected birds.
These
infections have led to symptoms of normal flu to more severe and life
threatening conditions. Influenza A (“H5N1”) is a subtype of an influenza virus
that is highly contagious among birds and can be very deadly to them. Of
the
avian influenza viruses that have crossed the species barrier to infect humans,
the H5N1 has caused the largest number of detected cases of severe disease
and
death in humans. In 2006, it is suspected that the Indonesia strain of H5N1
may
have mutated to result in limited spread from one person to another, only
in
close contact circumstances. It is possible that the substantially high case
fatality rate may be keeping the human to human spread in check. But as
influenza A viruses constantly change, they could mutate over time to have
the
ability to spread among humans.
Pandemic
Influenza
.
Pandemic
flu is a global disease outbreak that occurs when a new influenza virus emerges
so that people have had no previous exposure. This situation occurs very
rarely
and only occurred three times in the 20th century.
Flu
Prevention and Treatment.
The
development of effective therapeutics has challenged medical researchers
due to
the seasonal variation in viral strains and the highly infectious nature
of
influenza. Patients, therefore, have limited treatment options. Amantadine™ and
rimantadine™ are used for treatment of influenza A but are ineffective against
influenza B. In addition, these drugs cause some adverse side effects, and
the
virus tends to develop resistance to these drugs. For the 2005-2006 flu season,
the CDC has recommended against the use of amantadine and rimantadine for
the
treatment or prophylaxis of influenza in the United States due to signs of
resistance.
Vaccines
are
available against the disease but have limitations: people require advance
vaccination; vaccines are limited by their specificity to particular strains
of
the virus; and vaccines offer little protection if the vaccine is inaccurate.
In
addition, many people decline the required injections because of fear and/or
discomfort, as well as side effects such as allergies. The ability of the
virus
to change its structure to avoid the body’s natural defenses is a serious
obstacle to developing an effective vaccine against influenza. Different
strains
can arise when surface antigens on the virus (the portion of the virus that
causes an immune reaction in humans) undergo minor genetic mutations each
year
as the virus replicates. Because of this mutability, the immunity acquired
in
response to infection by a particular strain of the virus does not provide
adequate protection against viruses that subsequently arise. The production
of a
new vaccine each year is not only complex and expensive, but also an inefficient
method of global disease control. The time lag between threat potential
assignment and vaccine production implies that a novel influenza mutant can
develop in the field and may result in very poor vaccine response.
Inhibiting
Influenza Neuraminidase
.
Research
during the past two decades has seen dramatic advances in understanding the
molecular structure and function of the influenza virus. Considerable attention
has been focused on the enzyme neuraminidase, which is located on the surface
of
the virus particle. Neuraminidase assists in the release and spread of the
flu
virus by breaking the chemical strands that hold the new viruses to the cell
surface, allowing the replicated virus to spread and infect other cells.
This
process progresses until the host’s immune response can produce enough
antibodies to bring the infection under control. Inhibiting the neuraminidase
enzyme keeps new viruses attached to the cell surface, thereby preventing
the
spread of the virus and the further infection of other cells. The subsequent
quantities of virus in the bloodstream are not enough to cause disease but
are
sufficient to induce the body to mount an immune response.
Roche,
in
collaboration with Gilead Sciences, and GlaxoSmithKline (“GSK”) have currently
approved neuraminidase inhibitors on the market. Roche’s neuraminidase
inhibitor, oseltamivir aka Tamiflu(tm), is a twice-a-day, orally active
neuraminidase inhibitor, while GSK’s neuraminidase inhibitor, Relenza(tm), is
administered by dry powder inhaler twice a day. Both drugs are approved for
marketing in the United States and other countries for treatment of influenza.
Roche’s neuraminidase inhibitor is also approved for prophylaxis use for
prevention of influenza. In addition to these companies with neuraminidase
inhibitors, there are other companies working to develop vaccines and other
antiviral drugs to be used against various strains of
influenza.
BioCryst
is currently developing a neuraminidase inhibitor, peramivir, as an injectable,
for the treatment of common influenza as well as H5N1. While present
announcements from BioCryst indicate that injected peramivir is not
significantly more effective than Tamiflu, it appears that they believe that
the
good safety profile of peramivir may allow them to increase dose levels in
the
future studies to improve response.
Some
molecular biology oriented studies have described that there are significant
differences between the neuraminidase of the H5N1 strain and those of the
other
common influenza strains that may be responsible for the poor efficacy of
neuraminidase inhibitors as a class against H5N1.
Background:
Rabies
The
current protocol for treatment after exposure to Rabies (known as
post-exposure
prophylaxis
or
"P.E.P.") is highly successful in preventing the disease if administered
promptly, within fourteen days after infection. The first step is immediately
washing the wound with soap and water, which is very effective at reducing
the
number of viral particles. In the United States, patients receive one dose
of
immunoglobulin
and five
doses of rabies vaccine over a twenty-eight day period. One-half the dose
of
immunoglobulin is injected in the region of the bite, if possible, with the
remainder injected intramuscularly away from the bite. The first dose of
rabies
vaccine is given as soon as possible after exposure, with additional doses
on
days three, seven, fourteen, and twenty-eight after the first. Patients that
have previously received pre-exposure vaccination do not receive the
immunoglobulin, only the post-exposure vaccinations.
Because
of the significant expense of the rabies treatment, there is limited
availability in the rural areas of these underdeveloped countries (The cost
in
the U.S. is approximately $1,000 for a course of treatment).
At
the
request of the Vietnamese Ministry of Health, we initiated development of
an
anti-rabies drug. Rabies is a serious public health problem in Vietnam,
Thailand, India, and many other tropical and subtropical countries.
Our
first
RabiCide drug candidates will be tested at NIHE, Vietnam, in the first quarter
of 2007. There can be no assurance that our drug candidate (RabiCide) will
demonstrate efficacy against rabies and if developed, that the Company will
be
able to successfully manufacture the drugs so that the Company may commence
revenue-generating operations.
Background:
NanoViricides Company Philosophy
NanoViricides,
Inc. is a for-profit company. We have identified several diseases as large
commercially important drug development targets. These include HIV, Hepatitis
C,
Herpes Simplex Virus, and Influenzas, among others.
It
is
theoretically possible to develop nanoviricide drugs against a large number
of
infectious disease agents, primarily viruses. In this regard, there is a
potential to develop good nanoviricides against a large number of infectious
agents, including those that are primarily seen in developed countries and
well
as those primarily seen in developing and sub-tropical areas.
Significant
effort and scientific developments will be necessary in order to develop
nanoviricides against drugs that affect the brain, and the central nervous
system (CNS). This issue, a result of the blood-brain barrier, which does
not
allow drugs injected in the bloodstream to go into the CNS fluid is well
known.
This is a major barrier for all drug development against CNS diseases. It
will
be necessary to develop good nanoviricides against Dengue fever, West Nile
virus, and other diseases that progress only slowly to attack the CNS. This
may
well enable a time window for the nanoviricides to attack the virus in the
circulation before it has an opportunity to move into the central nervous
system.
It
is not
possible for any early-stage pharmaceutical company to expeditiously tackle
a
large number of disease targets without significant assistance and
collaborations, both financial and technical. We have not currently established
any of these collaborations.
Products
NanoViricides,
Inc. currently has no products for sale.
Products
In Development
The
following table summarizes NanoViricides active development projects as of
September 30, 2006.
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 2007
|
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 ligands that we have developed through rational drug design. These
ligands are based on a well known 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.
AviFluCide-I,
is currently in preclinical studies against H5N1, the avian influenza strain
that is considered the current pandemic threat. It is a highly specific drug
that also has extremely high activity against H5N1 in cell culture studies,
much
greater than our other two anti-influenza nanoviricides. Animal studies
utilizing AviFlucide-I against H5N1 are planned in the first quarter of 2007.
FluCide-HP,
is currently in preclinical studies against the entire class of highly
pathogenic avian influenza (HPAI) viruses from which pandemic threats emerge.
It
has excellent activity in cell culture studies against H5N1. Its activity
against common influenza is poorer than that of FluCide-I, yet better than
Tamiflu, in mouse studies. Common (low pathogenicity) influenza viruses do
not
have the characteristic surface features that HPAI viruses do. The ligand
used
for FluCide-HP was designed and developed by the Company using a rational
drug
design approach.
RabiCide-I,
a nanoviricide against Rabies is expected to enter animal studies in the
first
quarter of 2007. The candidate ligands for this nanoviricide were designed
by
the Company using publicly available information regarding the interaction
of
the rabies virus with cells.
HCV
-
A
Hepatitis
C nanoviricide is planned for research and development beginning in 2007.
The
Company has not yet sourced the materials to target this disease. The Company
has only begun the early stages of a plan to build nanoviricides against
Hepatitis C
HiviCide-I,
This is our first announced drug against HIV-I. Because of the world-wide
concern about a possible H5N1 pandemic, we moved HiviCide-I development back.
We
plan to reinitiate development of this drug late in 2007. Our first HIV drug
to
be developed will be a targeted nanoviricide against HIV that enters the
bloodstream upon injection and is engineered with specific recognition ligands
that allow multiple point binding to inactivate HIV virus in the
bloodstream.
HiviCide-II
will be a targeted nanoviricide against HIV strains that are not attacked
by
HiviCide-I, and will have the same mechanism of action as HiviCide-I, except
that it will possess a different ligand that specifies attacking a different
subset of virus strains, types, and subtypes than HiviCide-I.
All
of
these drugs are being developed as injectables.
Our
goals
for the second generation of our anti-influenza drugs will be to develop
an
oral/bronchial administration that carries the drug into the bronchial/pulmonary
space that is the primary site infection by influenza viruses. Moreover,
there
can be no assurance that we will be able to develop a drug that may be
administered orally or bronchially or that such a drug would be effective
against influenza.
Development
Stage of Products
All
of
above products are in various stages of pre-clinical development. The Company
believes that the anti-influenza drugs will advance into second stage of
preclinical studies, known as “Tox Package” studies, in 2007. The Company will
make a determination based on the results of its anti-influenza studies planned
during the first quarter 2007 as to how it should proceed with further
development of its drugs. All of our developments are subject to availability
of
appropriate levels of financing.
Plan
of Operations
The
Company intends to perform the regulatory filings and own all the regulatory
licenses for the drugs it is currently developing. The Company will develop
these drugs in part via subcontracts to TheraCour Pharma, Inc. (“TheraCour”),
the exclusive source for these nanomaterials. With sourcing of materials
from
TheraCour, the Company prefers to manufacture these drugs in our own facility.
However, the Company may manufacture these drugs under subcontract arrangements
with external manufacturers that carry the appropriate regulatory licenses
and
have appropriate capabilities. The Company intends to distribute these drugs
via
subcontracts with distributor companies or in partnership arrangements. The
Company plans to market these drugs either on its own or in conjunction with
marketing partners. The Company also plans to actively pursue co-development,
as
well as other licensing agreements with other Pharmaceutical companies. Such
agreements may entail up-front payments, milestone payments, royalties, and/or
cost sharing, profit sharing and many other instruments that may bring early
revenues to the Company. Such licensing and/or co-development agreements
may
shape the manufacturing and development options that the company may pursue.
None of these distributor or co-development agreements is in place at the
current time.
Manufacturing
Manufacturing
of Research Materials
Nanomaterials
that form the basis of our nanoviricide drugs are produced for research by
TheraCour Pharma, Inc. at their research scale production facility in West
Haven, Connecticut.
Manufacturing
of Drugs
The
Company is presently looking to acquire, build, or lease manufacturing
facilities that would enable GMP manufacturing of our drugs. Until such time,
the Company believes that its current relationship with TheraCour is sufficient
to meet its current developmental requirements.
The
Company intends to manufacture AviFluCide-I, AviFluCide-HP, FluCide-I and
RabiCide-I as well as other drugs for pre-clinical animal studies and human
clinical studies, in facilities owned or leased by the Company. In the event
that we cannot secure funding that allows us to establish the necessary
facilities to manufacture such drugs, we plan to subcontract with third party
facilities that have the appropriate capabilities and regulatory licenses
to
manufacture our drugs and materials on a commercial scale.
We
have
no commercial-scale manufacturing facilities at present. For our future
products, we will need to develop additional manufacturing capabilities and
establish additional third party suppliers to manufacture sufficient quantities
of our product candidates to undertake clinical trials and to manufacture
sufficient quantities of any products that are approved for commercial sale.
If
we are unable to develop manufacturing capabilities internally or contract
for
large scale manufacturing with third parties on acceptable terms for our
future
antiviral products, our ability to conduct large-scale clinical trials and
meet
customer demand for commercial products would be adversely affected.
We
believe that the technology we use to manufacture our products and compounds
is
proprietary. For our products, we may have to disclose all necessary aspects
of
this technology to contract manufacturers to enable them to manufacture the
products and compounds for us. We plan to have discussions with manufacturers
under non-disclosure and non-compete agreements that are intended to restrict
them from using or revealing this technology, but we cannot be certain that
these manufacturers will comply with these restrictions. In addition, these
manufacturers could develop their own technology related to the work they
perform for us that we may need to manufacture our products or compounds.
We
could be required to enter into an agreement with that manufacturer if we
wanted
to use that technology ourselves or allow another manufacturer to use that
technology. The manufacturer could refuse to allow us to use their technology
or
could demand terms to use their technology that are not acceptable.
We
believe that we are in compliance with all material environmental regulations
related to the manufacture of our products.
Patents
and Proprietary Rights
The
Company has an exclusive license in perpetuity for technologies developed
(with
materials referenced in Table 1 below) by Theracour for six virus types:
HIV,
Hepatitis C Virus, Herpes, Asian (bird) flu, Influenza, and rabies.
Nanoviricides, Inc has notified TheraCour Pharma of its interest in acquiring
licenses for others viruses.
In
consideration for obtaining this exclusive license, we agreed: (1) that
TheraCour can charge its costs (direct and indirect) plus a maximum of 30%
of
direct costs as a Development Fee payable in periodic installments as billed;
(2) we will pay $25,000 per month for usage of lab supplies and chemicals
from
existing stock held by TheraCour; (3) we will pay $2,000 or actual costs,
whichever is higher for other general and administrative expenses incurred
by
TheraCour on our behalf (4) to make royalty payments of fifteen percent (15%)
of
net sales of the licensed drugs to TheraCour Pharma, Inc.; (5) that TheraCour
Pharma, Inc. retain the exclusive right to develop and synthesize
nanomicelle(s), a small (approximately twenty nanometers in size) long chain
polymer based chemical structure, as component elements of the Licensed
Products. TheraCour Agreed that it will develop and synthesize such nanomicelle
exclusively for NanoViricides, and unless such license is terminated, will
not
develop or synthesize such nanomicelle for its own sake or for others; and
(6)
TheraCour may request and NanoViricides, Inc. will pay an advance payment
equal
to twice the amount of the previous months invoice to be applied as a prepayment
towards expenses.
TheraCour
Pharma, Inc., may terminate the license upon a material breach by us as
specified in the agreement. However, we may avoid such termination if within
90
days of receipt of such termination notice we cure the breach.
Development
costs charged by and paid to TheraCour Pharma, Inc. was $877,777 since inception
through September 30, 2006; $184,885 and $125,088 for the three months ended
September 30, 2006 and 2005, respectively; and $692,892 and $30,771 for the
years ended June 30, 2006 and 2005, respectively. No royalties are due or
have
been paid from inception through September 30, 2006.
TheraCour
Pharma, Inc. owns 35,370,000 shares of the Company’s 112,417,502 outstanding
shares of common stock as of September 30, 2006. Anil Diwan, the Company’s
President and Chairman of the Board, and Leo Ehrlich, our Chief Financial
Officer and Director, own approximately seventy-five percent (75%) of the
outstanding capitalization of TheraCour Pharma., Inc.
Patents
and other proprietary rights are essential for our operations. If we have
a
properly designed and enforceable patent, it can be more difficult for our
competitors to use our technology to create competitive products and more
difficult for our competitors to obtain a patent that prevents us from using
technology we create. As part of our business strategy, we actively seek
patent
protection both in the United States and internationally and intend to file
additional patent applications, when appropriate, to cover improvements in
our
compounds, products and technology. We also rely on trade secrets, internal
know-how, technological innovations and agreements with third parties to
develop, maintain and protect our competitive position. Our ability to be
competitive will depend on the success of this strategy.
The
Company believes that the drugs themselves, AviFlucide, FluCide, FluCide-HP,
RabiCide, HiviCide-I and II, and others, may be eligible for patent protection.
The Company plans on filing patent applications for protecting these drugs
when
we have definitive, replicatible results from either in-vitro or in-vivo
studies.
The
Company has licensed key patents, patent applications and rights to proprietary
and patent-pending technologies related to our compounds, products and
technologies (see Table 1), but we cannot be certain that issued patents
will be
enforceable or provide adequate protection or that pending patent applications
will result in issued patents.
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].
|
Of
the
patents and technologies licensed, the Company believes that the Company
will
not be using the intellectual property, compositions of matter, or other
aspects
described and secured under the US Patent No. US 6,521,736. This patent,
the
Company believes, discloses prototype materials that served to establish
the
proof of principles of Dr. Anil Diwan, the Company’s President and co-founder
whether such materials were possible to create and whether such materials
would
indeed be capable of encapsulation of pharmaceutically relevant compounds.
The
Company believes that the new and novel compositions disclosed in the new
patent
application, no. PCT/US06/01820, provide the necessary features that enable
the
development of nanoviricides. The Company believes that no other published
literature materials or existing patents are capable of providing all of
the
necessary features for this development, to the best of our knowledge. However,
the Company has no knowledge of the extensive active internal developments
at a
number of companies in the targeted therapeutics area.
We
may
obtain patents for our compounds many years before we obtain marketing approval
for them. Because patents have a limited life, which may begin to run prior
to
the commercial sale of the related product, the commercial value of the patent
may be limited. However, we may be able to apply for patent term extensions,
based on delays experienced in marketing products due to regulatory
requirements. There is no assurance we would be able to obtain such
extensions.
Patents
relating to pharmaceutical, biopharmaceutical and biotechnology products,
compounds and processes such as those that cover our existing compounds,
products and processes and those that we will likely file in the future,
do not
always provide complete or adequate protection. Future litigation or
reexamination proceedings regarding the enforcement or validity of our licensor,
TheraCour Pharma Inc.’s (TheraCour) existing patents or any future patents,
could invalidate TheraCour’s patents or substantially reduce their protection.
In addition, the pending patent applications and patent applications filed
by
TheraCour, may not result in the issuance of any patents or may result in
patents that do not provide adequate protection. As a result, we may not
be able
to prevent third parties from developing the same compounds and products
that we
have developed or are developing. In addition, certain countries do not permit
enforcement of our patents, and manufacturers are able to sell generic versions
of our products in those countries.
We
also
rely on unpatented trade secrets and improvements, unpatented internal know-how
and technological innovation. In particular, a great deal of our material
manufacturing expertise, which is a key component of our core material
technology, is not covered by patents but is instead protected as a trade
secret. We protect these rights mainly through confidentiality agreements
with
our corporate partners, employees, consultants and vendors. These agreements
provide that all confidential information developed or made known to an
individual during the course of their relationship with us will be kept
confidential and will not be used or disclosed to third parties except in
specified circumstances. In the case of employees, the agreements provide
that
all inventions made by the individual while employed by us will be our exclusive
property. We cannot be certain that these parties will comply with these
confidentiality agreements, that we have adequate remedies for any breach,
or
that our trade secrets will not otherwise become known or be independently
discovered by our competitors.
Competition
Our
products in development target a number of diseases and conditions that include
several different kinds of viral infections. There are many commercially
available products for these diseases and a large number of companies and
institutions are spending considerable amounts of money and other resources
to
develop additional products to treat these diseases. Most of these companies
have substantially greater financial and other resources, larger research
and
development staffs, and extensive marketing and manufacturing organizations.
If
we are able to successfully develop products, they would compete with existing
products based primarily on:
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insurance
and other reimbursement coverage;
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·
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adaptability
to various modes of dosing.
|
Our
drugs
in development for influenza,
Flucide,
AviFluCide, and FluCide HP would compete with neuraminidase inhibitors Tamiflu
and Relenza, anti-influenza drugs that are sold by Roche and Glaxo SmithKline
(GSK) , respectively. Generic competitors include amantadine and rimantadine,
both oral tablets that only inhibit the replication of the influenza A virus.
BioCryst Pharmaceuticals, Inc. is developing injectable formulations of
peramivir, an influenza neuraminidase inhibitor, for the treatment of influenza,
which is currently in preclinical trials.
Our
HCV
and HIV drugs are at the earliest stage of development. There are a growing
number of anti-HIV and HVC drugs being sold or are in advanced stages of
clinical development. Companies with HCV and HIV products include Bristol-Myers
Squibb Company (BMS), Roche, Boehringer Ingelheim, Merck & Co., Inc.
(Merck), Abbott Laboratories, and Schering Plough, in addition to several
other
pharmaceutical and biotechnology firms.
Currently
there are two accepted methods of rabies prophylaxis: rabies vaccines and
rabies
immune globulin, manufactured by many foreign and multinational manufacturers
including Aventis Pasteur and Chiron. These accepted methods will be the
standard against which our new anti-rabies drug in development will be
judged.
In
order
to compete successfully, we must develop proprietary positions in patented
drugs
for therapeutic markets. Our products, even if successfully tested and
developed, may not be adopted by physicians over other products and may not
offer economically feasible alternatives to other therapies.
Government
Regulation
Our
operations and activities are subject to extensive regulation by numerous
government authorities in the United States and other countries. In the United
States, drugs are subject to rigorous regulation by the United States Food
and
Drug Administration (“FDA”). The Federal Food, Drug and Cosmetic Act and other
federal and state statutes and regulations govern the testing, manufacture,
safety, effectiveness, labeling, storage, record keeping, approval, advertising
and promotion of our products. As a result of these regulations, product
development and the product approval process is very expensive and time
consuming.
The
FDA
must approve a drug before it can be sold in the United States. As of the
date
of this filing, t
he
FDA
has approved other nano-particulate drugs including Emend® by Merck and
Rapamune® by Wyeth, as well as others.
The
general process for FDA approval is as follows:
Preclinical
Testing
Before
we
can test a drug candidate in humans, we must study the drug in laboratory
experiments and in animals to generate data to support the drug’s potential
safety and benefits. We submit this data to the FDA in an investigational
new
drug application (IND) seeking their approval to test the compound in
humans.
Clinical
Trials
If
the
FDA accepts the investigational new drug application, we study the drug in
human
clinical trials to determine if the drug is safe and effective. These clinical
trials involve three separate phases that often overlap, can take many years
to
compile and are very expensive. These three phases, which are themselves
subject
to considerable regulation, are as follows:
s
Phase
1.
The drug is given to a small number of healthy human subjects or patients
to
test for safety, dose tolerance, pharmacokinetics, metabolism, distribution
and
excretion.
s
Phase
2.
The drug is given to a limited patient population to determine the effect
of the
drug in treating the disease, the best dose of the drug, and the possible
side
effects and safety risks of the drug.
s
Phase
3.
If a compound appears to be effective and safe in Phase 2 clinical trials,
Phase
3 clinical trials are commenced to confirm those results. Phase 3 clinical
trials are long-term, involve a significantly larger population, are conducted
at numerous sites in different geographic regions and are carefully designed
to
provide reliable and conclusive data regarding the safety and benefits of
a
drug. It is not uncommon for a drug that appears promising in Phase 2 clinical
trials to fail in the more rigorous and reliable Phase 3 clinical
trials.
FDA
Approval Process
If
we
believe that the data from the Phase 3 clinical trials show an adequate level
of
safety and effectiveness, we will file a new drug application (NDA) with
the FDA
seeking approval to sell the drug for a particular use. The FDA will review
the
NDA and often will hold a public hearing where an independent advisory committee
of expert advisors asks additional questions regarding the drug. This committee
makes a recommendation to the FDA that is not binding on the FDA but is
generally followed. If the FDA agrees that the compound has met the required
level of safety and effectiveness for a particular use, it will allow us
to sell
the drug in the United States for that use. It is not unusual, however, for
the
FDA to reject an application because it believes that the drug is not safe
enough or effective enough or because it does not believe that the data
submitted is reliable or conclusive.
At
any
point in this process, the development of a drug could be stopped for a number
of reasons including safety concerns and lack of treatment benefit. We cannot
be
certain that any clinical trials that we are currently conducting, or any
that
we conduct in the future, will be completed successfully or within any specified
time period. We may choose, or the FDA may require us, to delay or suspend
our
clinical trials at any time if it appears that the patients are being exposed
to
an unacceptable health risk or if the drug candidate does not appear to have
sufficient treatment benefit.
The
FDA
may also require us to complete additional testing, provide additional data
or
information, improve our manufacturing processes, procedures or facilities
or
may require extensive post-marketing testing and surveillance to monitor
the
safety or benefits of our product candidates if it determines that our new
drug
application does not contain adequate evidence of the safety and benefits
of the
drug. In addition, even if the FDA approves a drug, it could limit the uses
of
the drug. The FDA can withdraw approvals if it does not believe that we are
complying with regulatory standards or if problems are uncovered or occur
after
approval.
In
addition to obtaining FDA approval for each drug, we obtain FDA approval
of the
manufacturing facilities for any drug we sell, including those of companies
who
manufacture our drugs for us as well as our own and these facilities are
subject
to periodic inspections by the FDA. The FDA must also approve foreign
establishments that manufacture products to be sold in the United States
and
these facilities are subject to periodic regulatory inspection.
We
are
also subject to other federal, state and local regulations regarding workplace
safety and protection of the environment. We use hazardous materials, chemicals,
viruses and various radioactive compounds in our research and development
activities and cannot eliminate the risk of accidental contamination or injury
from these materials. Any misuse or accidents involving these materials could
lead to significant litigation, fines and penalties.
Drugs
are
also subject to extensive regulation outside of the United States. In the
European Union, there is a centralized approval procedure that authorizes
marketing of a product in all countries in the European Union (which includes
most major countries in Europe). If this procedure is not used, under a
decentralized system, an approval in one country of the European Union can
be
used to obtain approval in another country of the European Union under a
simplified application process at present. After approval under the centralized
procedure, pricing and reimbursement approvals are also required in most
countries. These procedures are undergoing revision and modification at present.
We have never received approval for a product in the European Union to
date.
Employees
As
of
September 30, 2006, the Company had five full time employees. The Company
has
subcontracted research and development (“R&D”) to TheraCour. We believe that
we have good relations with our employees and subcontractors.
Reports
to Security Holders
As
a
result of its filing of this Form 10-SB, the Company expects to become subject
to the reporting obligations of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”). These obligations include filing an annual report under
cover of Form 10-KSB, with audited financial statements, unaudited quarterly
reports on Form 10-QSB and the requisite proxy statements with regard to
annual
shareholder meetings. The public may read and copy any materials the Company
files with the Securities and Exchange Commission (the “Commission”) at the
Commission’s Public Reference Room at 100 F Street, NE, Washington, DC 20549.
The public may obtain information on the operation of the Public Reference
Room
by calling the Commission at 1-800-SEC-0030. The Commission maintains an
Internet site (http://www.sec.gov) that contains reports, proxy and information
statements and other information regarding issuers that file electronically
with
the Commission. Information about the Company is also available on its Web
site
at www.nanoviricides.com. Information included on the Web site is not part
of
this Form 10-SB.
Website
Our
website address is
www.nanoviricides.com
.
We
intend
to make available through our website, all of our filings with the Commission
and all amendments to these reports as soon as reasonably practicable after
filing, by providing a hyperlink to the EDGAR website containing our
reports.
Our
Information
Our
principal executive offices are located at 135 Wood St. West Haven, Connecticut
06516 and our telephone number is (203) 937-6137.
RISK
FACTORS
This
Registration Statement contains forward-looking statements that involve risks
and uncertainties. These statements can be identified by the use of
forward-looking terminology such as “believes,” “expects,” “intends,” “plans,”
“may,” “will,” “should,” or “anticipation” or the negative thereof or other
variations thereon or comparable terminology. Actual results could differ
materially from those discussed in the forward-looking statements as a result
of
certain factors, including those set forth below and elsewhere in this
Registration Statement. The following risk factors should be considered
carefully in addition to the other information in this Registration Statement,
before purchasing any of the Company’s securities.
Risks
Specific to Us
Our
company is a development stage company that has no products approved for
commercial sale, never generated any revenues and may never achieve revenues
or
profitability.
We
are a
development stage biopharmaceutical company. Currently, we have no products
approved for commercial sale and, to date, we have not generated any revenues.
Our ability to generate revenue depends heavily on:
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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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the
successful commercialization of our product candidates;
and
|
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market
acceptance of our products.
|
All
of
our existing product candidates are in early stages of development. If we
do not
successfully develop and commercialize these products, we will not achieve
revenues or profitability in the foreseeable future, if at all. If we are
unable
to generate revenues or achieve profitability, we may be unable to continue
our
operations.
We
are a development stage company with a limited operating history, making
it
difficult for you to evaluate our business and your
investment.
We
are in
the development stage and our operations and the development of our proposed
products are subject to all of the risks inherent in the establishment of
a new
business enterprise, including but not limited to:
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the
absence of an operating history;
|
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the
lack of commercialized products;
|
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–
|
expected
substantial and continual losses for the foreseeable
future;
|
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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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an
expected reliance on third parties for the development and
commercialization of our proposed
products;
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a
competitive environment characterized by numerous, well-established
and
well capitalized competitors; and
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reliance
on key personnel.
|
Because
we are subject to these risks, you may have a difficult time evaluating our
business and your investment in our company.
Our
ability to become profitable depends primarily on the following
factors:
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–
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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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our
ability to enter into favorable alliances with third-parties who
can
provide substantial capabilities in clinical development, regulatory
affairs, sales, marketing and
distribution.
|
Even
if
we successfully develop and market our drug candidates, we may not generate
sufficient or sustainable revenue to achieve or sustain
profitability.
The
report of our independent registered public accounting firm includes a going
concern qualification, and we have incurred significant operating losses
and may
not be profitable in the future, if ever.
As
of
September 30, 2006 we have a cash balance of approximately $1,777,000 which
can
support operations through March 2007, but not through our fiscal year end
of
June 30, 2007. Also, the Company has incurred significant operating losses
since
its inception, resulting in an accumulated deficit of $4,090,809 at September
30, 2006. Such losses are expected to continue for the foreseeable
future.
Our
history of losses, operating cash needs, cash consumption, and doubt as to
whether we will ever become profitable, are factors which raise substantial
doubt as to our ability to continue as a going concern. Consequently, our
independent registered public accounting firm has included a going concern
qualification in its report which is included elsewhere in this Form 10-SB.
It
is uncertain at this time how the going concern qualification by our independent
registered public accounting firm will effect our ability to raise capital.
If
we are unable to achieve revenues or obtain financing, then we may not be
able
to commence revenue-generating operations or continue as an on-going
concern.
We
will need to raise substantial additional capital in the future to fund our
operations and we may be unable to raise such funds when needed and on
acceptable terms.
We
currently do not have sufficient resources to complete the development and
commercialization of any of our proposed products.
As
of
September 30, 2006 we have a cash balance of approximately $1,777,000 which
can
support operations through March 2007, but will not be sufficient to fund
our
operations for the next twelve months. We expect to incur costs of approximately
$5 million dollars in the upcoming twelve months to operate our business
in
accordance with our business plans.
We
presently do not have reserves of
$5,000,000
and
require
a
minimum financing of $3 million dollars to operate our business over the
upcoming 12 months. We may not be able to secure this amount of financing
on
acceptable terms. In the event that we cannot obtain acceptable financing,
we
would be unable to complete development of our influenza drugs. This will
necessitate implementing staff reductions and operational adjustments that
would
include reductions in the following business areas:
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research
and development programs;
|
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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.
|
The
amount of capital we may need will depend on many factors, including
the:
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·
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progress,
timing and scope of our research and development
programs;
|
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progress,
timing and scope of our preclinical studies and clinical
trials;
|
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time
and cost necessary to obtain regulatory
approvals;
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time
and cost necessary to establish our own marketing capabilities
or to
seek
marketing partners;
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time
and cost necessary to respond to technological and market
developments;
|
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changes
made or new developments in our existing collaborative, licensing
and
|
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other
commercial relationships; and
|
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new
collaborative, licensing and other commercial relationships that
we may
establish.
|
Our
fixed
expenses, such as rent, license payments and other contractual commitments,
may
increase in the future, as we may:
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enter
into leases for new facilities and capital
equipment;
|
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enter
into additional licenses and collaborative agreements;
and
|
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incur
additional expenses associated with being a public
company.
|
We
have limited experience in drug development and may not be able to successfully
develop any drugs.
We
have
limited experience in drug development and may not be able to successfully
develop any drugs. Our ability to achieve revenues and profitability in our
business will depend, among other things, on our ability to:
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develop
products internally or obtain rights to them from others on favorable
terms;
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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
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enter
into arrangements with third parties to manufacture our products
on our
behalf; and
|
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enter
into arrangements with third parties to provide sales and marketing
functions.
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Development
of pharmaceutical products is a time-consuming process, subject to a number
of
factors, many of which are outside of our control. Consequently, we can provide
no assurance of the successful and timely development of new
drugs.
Our
drug
candidates are in their developmental stage. Further development and extensive
testing will be required to determine their technical feasibility and commercial
viability. Our success will depend on our ability to achieve scientific and
technological advances and to translate such advances into reliable,
commercially competitive drugs on a timely basis. Drugs that we may develop
are
not likely to be commercially available for a few years. The proposed
development schedules for our drug candidates may be affected by a variety
of
factors, including technological difficulties, proprietary technology of
others,
and changes in government regulation, many of which will not be within our
control. Any delay in the development, introduction or marketing of our drug
candidates could result either in such drugs being marketed at a time when
their
cost and performance characteristics would not be competitive in the marketplace
or in the shortening of their commercial lives. In light of the long-term
nature
of our projects, the unproven technology involved and the other factors
described elsewhere in “Risk Factors”, we may not be able to complete
successfully the development or marketing of any drugs.
We
may
fail to successfully develop and commercialize our drug candidates because
they:
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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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Drug
development failure can occur at any stage of clinical trials and as a result
of
many factors and there can be no assurance that we or our collaborators will
reach our anticipated clinical targets. Even if we or our collaborators complete
our clinical trials, we do not know what the long-term effects of exposure
to
our drug candidates will be. Furthermore, our drug candidates may be used
in
combination with other treatments and there can be no assurance that such
use
will not lead to unique safety issues. Failure to complete clinical trials
or to
prove that our drug candidates are safe and effective would have a material
adverse effect on our ability to generate revenue and could require us to
reduce
the scope of or discontinue our operations.
We
must comply with significant and complex government regulations, compliance
with
which may delay or prevent the commercialization of our drug
candidates.
The
R&D, manufacture and marketing of drug candidates are subject to regulation,
primarily by the FDA in the United States and by comparable authorities in
other
countries. These national agencies and other federal, state, local and foreign
entities regulate, among other things, R&D activities (including testing in
primates and in humans) and the testing, manufacturing, handling, labeling,
storage, record keeping, approval, advertising and promotion of the products
that we are developing. Noncompliance with applicable requirements can result
in
various adverse consequences, including approval delays or refusals to approve
drug licenses or other applications, suspension or termination of clinical
investigations, revocation of approvals previously granted, fines, criminal
prosecution, recalls or seizures of products, injunctions against shipping
drugs
and total or partial suspension of production and/or refusal to allow a company
to enter into governmental supply contracts.
The
process of obtaining FDA approval has historically been costly and time
consuming. Current FDA requirements for a new human drug or biological product
to be marketed in the United States include: (1) the successful conclusion
of
pre-clinical laboratory and animal tests, if appropriate, to gain preliminary
information on the product’s safety; (2) filing with the FDA of an IND
application to conduct human clinical trials for drugs or biologics; (3)
the
successful completion of adequate and well-controlled human clinical
investigations to establish the safety and efficacy of the product for its
recommended use; and (4) filing by a company and acceptance and approval
by the
FDA of a New Drug Application, or NDA, for a drug product or a biological
license application, or BLA, for a biological product to allow commercial
distribution of the drug or biologic. A delay in one or more of the procedural
steps outlined above could be harmful to us in terms of getting our drug
candidates through clinical testing and to market.
The
FDA
reviews the results of the clinical trials and may order the temporary or
permanent discontinuation of clinical trials at any time if it believes the
drug
candidate exposes clinical subjects to an unacceptable health risk.
Investigational drugs used in clinical studies must be produced in compliance
with current good manufacturing practice, or GMP, rules pursuant to FDA
regulations.
Sales
outside the United States of products that we develop will also be subject
to
regulatory requirements governing human clinical trials and marketing for
drugs
and biological products and devices. The requirements vary widely from country
to country, but typically the registration and approval process takes several
years and requires significant resources. In most cases, even if the FDA
has not
approved a product for sale in the United States, the product may be exported
to
any country if it complies with the laws of that country and has valid marketing
authorization by the appropriate authority. There are specific FDA regulations
that govern this process.
We
also
are subject to the following risks and obligations, related to the approval
of
our products:
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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.
|
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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.
|
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The
FDA or foreign regulators may not approve our manufacturing processes
or
manufacturing facilities.
|
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The
FDA or foreign regulators may change their approval policies or
adopt new
regulations.
|
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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.
|
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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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We
will be subject to continual regulatory review and periodic inspection
and
approval of manufacturing modifications, including compliance with
current
GMP regulations.
|
We
can provide no assurance that our drug candidates will obtain regulatory
approval or that the results of clinical studies will be
favorable.
The
work-plan we have developed for the next twelve months is planned to enable
us
to file an Investigational New Drug (“IND”)application for our influenza and
rabies drugs in our 2007-2008 fiscal year. We believe that this work-plan
will
lead us to obtain certain information about the safety and efficacy of our
influenza and rabies drug which are in the earliest stages of development.
If
our studies are successful, then we need to be able to undertake further
studies
in animal models to obtain necessary data regarding the pharmaco-kinetic
and
pharmaco-dynamic profiles of our drug candidates. The data will then be used
to
file an IND application, towards the goal of obtaining FDA approval for testing
the drugs in human patients.
The
testing, marketing and manufacturing of any product for use in the United
States
will require approval from the FDA. We cannot predict with any certainty
the
amount of time necessary to obtain such FDA approval and whether any such
approval will ultimately be granted Preclinical and clinical trials may reveal
that one or more products are ineffective or unsafe, in which event further
development of such products could be seriously delayed or terminated. Moreover,
obtaining approval for certain products may require testing on human subjects
of
substances whose effects on humans are not fully understood or documented.
Delays in obtaining FDA or any other necessary regulatory approvals of any
proposed drug and failure to receive such approvals would have an adverse
effect
on the drug’s potential commercial success and on our business, prospects,
financial condition and results of operations. In addition, it is possible
that
a proposed drug may be found to be ineffective or unsafe due to conditions
or
facts that arise after development has been completed and regulatory approvals
have been obtained. In this event, we may be required to withdraw such proposed
drug from the market. To the extent that our success will depend on any
regulatory approvals from government authorities outside of the United States
that perform roles similar to that of the FDA, uncertainties similar to those
stated above will also exist.
Even
if we obtain regulatory approvals, our marketed drug candidates will be subject
to ongoing regulatory review. If we fail to comply with continuing U.S. and
foreign regulations, we could lose our approvals to market these drugs and
our
business would be seriously harmed.
Following
any initial regulatory approval of any drugs we may develop, we will also
be
subject to continuing regulatory review, including the review of adverse
experiences and clinical results that are reported after our drug candidates
are
made commercially available. This would include results from any post-marketing
tests or vigilance required as a condition of approval. The manufacturer
and
manufacturing facilities we use to make any of our drug candidates will also
be
subject to periodic review and inspection by the FDA. The discovery of any
previously unknown problems with the drug, manufacturer or facility may result
in restrictions on the drug or manufacturer or facility, including withdrawal
of
the drug from the market. If we are required to withdraw all or more of our
drugs from the market, we may be unable to continue revenue generating
operations. We do not have, and currently do not intend to develop, the ability
to manufacture material for our clinical trials or on a commercial scale.
Reliance on third-party manufacturers entails risks to which we would not
be
subject if we manufactured drugs ourselves, including reliance on the
third-party manufacturer for regulatory compliance. Our drug promotion and
advertising is also subject to regulatory requirements and continuing FDA
review.
Development
of our drug candidates requires a significant investment in R&D. Our R&D
expenses in turn, are subject to variation based on a number of factors,
many of
which are outside of our control. A sudden or significant increase in our
R&D expenses could materially and adversely impact our results of
operations.
We
have
expended $1,115,547 on research and development from inception through September
30, 2006. We have an R&D budget of
$1,500,000
for
the
next
12 months. This includes $1,200,000 for multiple drug variations and in-vivo
and
in-vitro studies for FluCide™, AviFluCide™, FluCide HP™, and Rabies planned for
the first calendar quarter of 2007. Depending on the results of these clinical
trials, we expect to commence with early stage development of a drug for
Hepatitis C (HCV) for which we have budgeted $300,000. The Company has the
available cash on hand to complete the R&D work scheduled through March
2007. However should the clinical trials of our influenza and rabies drugs
in
the first quarter of 2007 meet managements expectations the Company has budgeted
an additional $1,500,000 for the costs of hiring additional scientific staff
and
consulting firms to assist with FDA compliance, material characterization,
pharmaco-kinetic, pharmaco-dynamic and toxicology studies.
The
Company will be unable to proceed with its planned R&D beyond the first
quarter of 2007, without obtaining additional financing of approximately
$1,800,000.
Because
we expect to expend substantial resources on R&D, our success depends in
large part on the results as well as the costs of our R&D. A failure in our
R&D efforts or substantial increase in our R&D expenses would adversely
affect our results of operations. R&D expenditures are uncertain and subject
to much fluctuation. Factors affecting our R&D expenses include, but are not
limited to:
|
·
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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;
|
|
·
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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.
|
We
have no experience in conducting or supervising clinical trials and must
outsource all clinical trials.
We
have
no experience in conducting or supervising clinical trials that must be
performed to obtain data to submit in concert with applications for approval
by
the Food and Drug Administration ("FDA"). The regulatory process to obtain
approval for drugs for commercial sale involves numerous steps. Drugs are
subjected to clinical trials that allow development of case studies to examine
safety, efficacy, and other issues to ensure that sale of drugs meets the
requirements set forth by various governmental agencies, including the FDA.
In
the event that our protocols do not meet standards set forth by the FDA,
or that
our data is not sufficient to allow such trials to validate our drugs in
the
face of such examination, we might not be able to meet the requirements that
allow our drugs to be approved for sale.
Because
we have no experience in conducting or supervising clinical trials, we must
outsource our clinical trials to third parties. We have no control over their
compliance with procedures and protocols used to complete clinical trails
in
accordance with standards required by the agencies that approve drugs for
sale.
If these subcontractors fail to meet these standards, the validation of our
drugs would be adversely affected, causing a delay in our ability to meet
revenue-generating operations
We
are subject to risks inherent in conducting clinical trials. The risk of
non
compliance with FDA-approved good clinical practices by clinical investigators,
clinical sites, or data management services could delay or prevent us from
developing or ever commercializing our drug
candidates.
Agreements
with clinical investigators and medical institutions for clinical testing
and
with other third parties for data management services place substantial
responsibilities on these parties, which could result in delays in, or
termination of, our clinical trials if these parties fail to perform as
expected. For example, if any of our clinical trial sites fail to comply
with
FDA-approved good clinical practices, we may be unable to use the data gathered
at those sites. If these clinical investigators, medical institutions or
other
third parties do not carry out their contractual duties or obligations or
fail
to meet expected deadlines, or if the quality or accuracy of the clinical
data
they obtain is compromised due to their failure to adhere to our clinical
protocols or for other reasons, our clinical trials may be extended, delayed
or
terminated, and we may be unable to obtain regulatory approval for or
successfully commercialize our drug candidates.
We
or
regulators may suspend or terminate our clinical trials for a number of reasons.
We may voluntarily suspend or terminate our clinical trials if at any time
we
believe that they present an unacceptable risk to the patients enrolled in
our
clinical trials. In addition, regulatory agencies may order the temporary
or
permanent discontinuation of our clinical trials at any time if they believe
that the clinical trials are not being conducted in accordance with applicable
regulatory requirements or that they present an unacceptable safety risk
to the
patients enrolled in our clinical trials.
Our
clinical trial operations will be subject to regulatory inspections at any
time.
If regulatory inspectors conclude that we or our clinical trial sites are
not in
compliance with applicable regulatory requirements for conducting clinical
trials, we may receive reports of observations or warning letters detailing
deficiencies, and we will be required to implement corrective actions. If
regulatory agencies deem our responses to be inadequate, or are dissatisfied
with the corrective actions that we or our clinical trial sites have
implemented, our clinical trials may be temporarily or permanently discontinued,
we may be fined, we or our investigators may be precluded from conducting
any
ongoing or any future clinical trials, the government may refuse to approve
our
marketing applications or allow us to manufacture or market our drug candidates
or we may be criminally prosecuted. If we are unable to complete clinical
trials
and have our products approved due to our failure to comply with regulatory
requirements, we will be unable to commence revenue generating
operations.
Efforts
of government and third-party payors to contain or reduce the costs of health
care may adversely affect our revenues even if we were to develop an FDA
approved drug.
Our
ability to earn sufficient returns on our drug candidates may depend in part
on
the extent to which government health administration authorities, private
health
coverage insurers and other organizations will provide reimbursement for
the
costs of such drugs and related treatments. Significant uncertainty exists
as to
the reimbursement status of newly approved health care drugs, and we do not
know
whether adequate third-party coverage will be available for our drug candidates.
If our current and proposed drugs are not considered cost-effective,
reimbursement to the consumers may not be available or sufficient to allow
us to
sell drugs on a competitive basis. The failure of the government and third-party
payors to provide adequate coverage and reimbursement rates for our drug
candidates could adversely affect the market acceptance of our drug candidates,
our competitive position and our financial performance.
If
we
fail to comply with applicable continuing regulatory requirements, we may
be
subject to fines, suspension or withdrawal of regulatory approval, product
recalls and seizures, operating restrictions and criminal prosecutions.
Confidentiality
agreements with employees and others may not adequately prevent disclosure
of
trade secrets and other proprietary information. Disclosure of our trade
secrets
or proprietary information could compromise any competitive advantage that
we
have.
We
depend
upon confidentiality agreements with our officers, employees, consultants,
and
subcontractors to maintain the proprietary nature of the technology. These
measures may not afford us sufficient or complete protection, and may not
afford
an adequate remedy in the event of an unauthorized disclosure of confidential
information. In addition, others may independently develop technology similar
to
ours, otherwise avoiding the confidentiality agreements, or produce patents
that
would materially and adversely affect our business, prospects, financial
condition, and results of operations.
We
will rely upon licensed patents to protect our technology. We may be unable
to
obtain or protect such intellectual property rights, and we may be liable
for
infringing upon the intellectual property rights of
others.
Our
ability to compete effectively will depend on our ability to maintain the
proprietary nature of our technologies and the proprietary technology of
others
with which we have entered into licensing agreements. We have exclusively
licensed patent applications from TheraCour Pharma, Inc and expect to file
patents of our own in the coming years. There can be no assurance that any
of
these patent applications will ultimately result in the issuance of a patent
with respect to the technology owned by us or licensed to us. The patent
position of pharmaceutical or biotechnology companies, including ours, is
generally uncertain and involves complex legal and factual considerations.
The
standards that the United States Patent and Trademark Office use to grant
patents are not always applied predictably or uniformly and can change. There
is
also no uniform, worldwide policy regarding the subject matter and scope
of
claims granted or allowable in pharmaceutical or biotechnology patents.
Accordingly, we do not know the degree of future protection for our proprietary
rights or the breadth of claims that will be allowed in any patents issued
to us
or to others. Further, we rely on a combination of trade secrets, know-how,
technology and nondisclosure, and other contractual agreements and technical
measures to protect our rights in the technology. If any trade secret, know-how
or other technology not protected by a patent were to be disclosed to or
independently developed by a competitor, our business and financial condition
could be materially adversely affected.
We
do not
believe that any of the drug candidates we are currently developing infringe
upon the rights of any third parties nor are they infringed upon by third
parties; however, there can be no assurance that our technology will not
be
found in the future to infringe upon the rights of others or be infringed
upon
by others. In such a case, others may assert infringement claims against
us, and
should we be found to infringe upon their patents, or otherwise impermissibly
utilize their intellectual property, we might be forced to pay damages,
potentially including treble damages, if we are found to have willfully
infringed on such parties’ patent rights. In addition to any damages we might
have to pay, we may be required to obtain licenses from the holders of this
intellectual property, enter into royalty agreements, or redesign our drug
candidates so as not to utilize this intellectual property, each of which
may
prove to be uneconomical or otherwise impossible. Conversely, we may not
always
be able to successfully pursue our claims against others that infringe upon
our
technology and the technology exclusively licensed from the TheraCour Pharma
Inc. Thus, the proprietary nature of our technology or technology licensed
by us
may not provide adequate protection against competitors.
Moreover,
the cost to us of any litigation or other proceeding relating to our patents
and
other intellectual property rights, even if resolved in our favor, could
be
substantial, and the litigation would divert our management’s efforts.
Uncertainties resulting from the initiation and continuation of any litigation
could limit our ability to continue our operations.
Other
companies or organizations may assert patent rights that prevent us from
developing and commercializing our drug candidates.
We
are in
a relatively new scientific field that has generated many different patent
applications from organizations and individuals seeking to obtain important
patents in the field. Because the field is so new, very few of these patent
applications have been fully processed by government patent offices around
the
world, and there is a great deal of uncertainty about which patents will
issue,
when, to whom, and with what claims. It is likely that there will be significant
litigation and other proceedings, such as interference proceedings in various
patent offices, relating to patent rights in the field. Others may attempt
to
invalidate our patents or other intellectual property rights. Even if our
rights
are not directly challenged, disputes among third parties could lead to the
weakening or invalidation of those intellectual property
rights.
Thus,
it
is possible that one or more organizations will hold patent rights to which
we
will need a license. Any license required under any patent may not be made
available on commercially acceptable terms, if at all. In addition, such
licenses are likely to be non-exclusive and, therefore, our competitors may
have
access to the same technology licensed to us. If we fail to obtain a required
license and are unable to design around a patent, we may be unable to
effectively market some of our technology and drug candidates, which could
limit
our ability to generate revenues or achieve profitability and possibly prevent
us from generating revenue sufficient to sustain our operations.
We
are
dependent upon
TheraCour
Pharma Inc
.
for the
rights to develop the products we intend to sell.
Our
ability to develop, manufacture and sell the products the Company plans to
develop is derived from our “Material Licensing Agreement” with
TheraCour
Pharma Inc (“TheraCour”). While we hold the license in perpetuity, the Agreement
may be terminated by TheraCour as a result of: the insolvency or bankruptcy
proceedings by or against the Company, a general assignment by the Company
to is
creditors, the dissolution of the Company, cessation by the Company of business
operations for ninety (90) days or more or the commencement by the Company
or an
affiliate to challenge or invalidate the issued patents.
The
Company does not hold the rights to any other patents nor does the Company
conduct its own research and development to develop other products to
manufacture and sell. If the Company’s Agreement with TheraCour is terminated,
it is unlikely we will be able to commence revenue-generating operations
or that
the Company could continue operating at all
We
lack suitable facilities for clinical testing; reliance on third
parties
The
Company does not have facilities that could be used to conduct clinical testing.
We expect to contract with third parties to conduct all clinical testing
required to obtain approvals for any drugs that we might develop. We currently
outsource all clinical testing to KARD scientific and the Vietnamese National
Institute of Hygiene and Epidemiology (NIHE), and are reliant on the services
of
these third parties to conduct studies on our behalf. KARD is not under contract
to perform studies for us and NIHE may discontinue their collaboration at
any
time. If we are unable to continue with KARD Scientific or NIHE, or retain
third
parties for these purposes on acceptable terms, we may be unable to successfully
develop our proposed products. In addition, any failures by third parties
to
adequately perform their responsibilities may delay the submission of our
proposed products for regulatory approval, impair our ability to deliver
our
products on a timely basis or otherwise impair our competitive position.
(The
agreement with NIHE is filed as an Exhibit to this 10SB).
We
have limited manufacturing experience
The
Company has never manufactured products in the highly regulated environment
of
pharmaceutical manufacturing. There are numerous regulations and requirements
that must be maintained to obtain licensure and permitting required to commence
manufacturing, as well as additional requirements to continue manufacturing
pharmaceutical products. We do not own or lease facilities currently that
could
be used to manufacture any products that might be developed by the Company,
nor
do we have the resources at this time to acquire or lease suitable facilities.
We
have no sales and marketing personnel.
We
are an
early stage development Company with limited resources. We do not currently
have
any products available for sale, so have not secured sales and marketing
staff
at this early stage of operations. We cannot generate sales without sales
or
marketing staff and must rely on officers to provide any sales or marketing
services until such staff are secured, if ever.
Even
if we were to successfully develop approvable drugs, we will not be able
to sell
these drugs if we or our third party manufacturers fail to comply with
manufacturing regulations.
If
we
were to successfully develop approvable drugs, before we can begin selling
these
drugs, we must obtain regulatory approval of our manufacturing facility and
process or the manufacturing facility and process of the third party or parties
with whom we may outsource our manufacturing activities. In addition, the
manufacture of our products must comply with the FDA's current Good
Manufacturing Practices regulations, commonly known as GMP regulations. The
GMP
regulations govern quality control and documentation policies and procedures.
Our manufacturing facilities, if any in the future, and the manufacturing
facilities of our third party manufacturers will be continually subject to
inspection by the FDA and other state, local and foreign regulatory authorities,
before and after product approval. We cannot guarantee that we, or any potential
third party manufacturer of our products, will be able to comply with the
GMP
regulations or other applicable manufacturing regulations.
We
license our core technology from
TheraCour
Pharma Inc.
and
we are dependent upon them as they have exclusive development
rights.
If we lose the right to utilize any of the proprietary information that is
the
subject of this license agreement, we may incur substantial delays and costs
in
development of our drug candidates.
The
Company has entered into a Material License Agreement with TheraCour Pharma,
Inc. (“TheraCour”) (an approximately 31% shareholder of the Company’s common
stock) whereby TheraCour has exclusive rights to develop exclusively for
us, the
materials that comprise the core drugs of our planned business. TheraCour
is a
development stage company with limited financial resources and needs the
Company’s progress payments to further the development of the
nanoviricides
.
See
Also
Item 7. Certain Relationships and Related Transactions.
We
depend
on TheraCour and other third parties to perform manufacturing activities
effectively and on a timely basis. If these third parties fail to perform
as
required, this could impair our ability to deliver our products on a timely
basis or cause delays in our clinical trials and applications for regulatory
approval, and these events could harm our competitive position and adversely
affect our ability to commence revenue generating operations. The manufacturing
process for pharmaceutical products is highly regulated, and regulators may
shut
down manufacturing facilities that they believe do not comply with regulations.
We and our manufacturers are subject to the FDA’s current Good Manufacturing
Practices, which are extensive regulations governing manufacturing processes,
stability testing, record-keeping and quality standards and similar regulations
are in effect in other countries. In addition, our manufacturing operations
are
subject to routine inspections by regulatory agencies.
Our
collaborative relationships with third parties could cause us to expend
significant resources and incur substantial business risk with no assurance
of
financial return.
We
anticipate substantial reliance upon strategic collaborations for marketing
and
the commercialization of our drug candidates and we may rely even more on
strategic collaborations for R&D of our other drug candidates. Our business
depends on our ability to sell drugs to both government agencies and to the
general pharmaceutical market. Offering our drug candidates for non-medical
applications to government agencies does not require us to develop new sales,
marketing or distribution capabilities beyond those already existing in the
company. Selling antiviral drugs, however, does require such development.
We
plan to sell antiviral drugs through strategic partnerships with pharmaceutical
companies. If we are unable to establish or manage such strategic collaborations
on terms favorable to us in the future, our revenue and drug development
may be
limited. To date, we have not entered into any strategic collaborations with
third parties capable of providing these services. In addition, we have not
yet
marketed or sold any of our drug candidates or entered into successful
collaborations for these services in order to ultimately commercialize our
drug
candidates.
If
we
determine to enter into R&D collaborations during the early phases of drug
development, our success will in part depend on the performance of our research
collaborators. We will not directly control the amount or timing of resources
devoted by our research collaborators to activities related to our drug
candidates. Our research collaborators may not commit sufficient resources
to
our programs. If any research collaborator fails to commit sufficient resources,
our preclinical or clinical development programs related to this collaboration
could be delayed or terminated. Also, our collaborators may pursue existing
or
other development-stage products or alternative technologies in preference
to
those being developed in collaboration with us. Finally, if we fail to make
required milestone or royalty payments to our collaborators or to observe
other
obligations in our agreements with them, our collaborators may have the right
to
terminate those agreements.
Manufacturers
producing our drug candidates must follow current GMP regulations enforced
by
the FDA and foreign equivalents. If a manufacturer of our drug candidates
does
not conform to the current GMP regulations and cannot be brought up to such
a
standard, we will be required to find alternative manufacturers that do conform.
This may be a long and difficult process, and may delay our ability to receive
FDA or foreign regulatory approval of our drug candidates and cause us to
fall
behind on our business objectives.
Establishing
strategic collaborations is difficult and time-consuming. Our discussion
with
potential collaborators may not lead to the establishment of collaborations
on
favorable terms, if at all. Potential collaborators may reject collaborations
based upon their assessment of our financial, regulatory or intellectual
property position. Even if we successfully establish new collaborations,
these
relationships may never result in the successful development or
commercialization of our drug candidates or the generation of sales revenue.
To
the extent that we enter into collaborative arrangements, our drug revenues
are
likely to be lower than if we directly marketed and sold any drugs that we
may
develop.
Management
of our relationships with our collaborators will require:
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significant
time and effort from our management team;
|
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|
coordination
of our marketing and R&D programs with the marketing and R&D
priorities of our collaborators;
and
|
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effective
allocation of our resources to multiple projects.
|
We
employ the use of certain chemical and biological agents and compounds that
may
be deemed hazardous and we are therefore subject to various environmental
laws
and regulations. Compliance with these laws and regulations may result in
significant costs, which could materially reduce our ability to become
profitable.
We
use
hazardous materials, including chemicals and biological agents and compounds
that could be dangerous to human health and safety or the environment. As
appropriate, we safely store these materials and wastes resulting from their
use
at our laboratory facility pending their ultimate use or disposal. We contract
with a third party to properly dispose of these materials and wastes. We
are
subject to a variety of federal, state and local laws and regulations governing
the use, generation, manufacture, storage, handling and disposal of these
materials and wastes. We may incur significant costs complying with
environmental laws and regulations adopted in the future.
If
we use biological and hazardous materials in a manner that causes injury,
we may
be liable for damages.
Our
R&D and manufacturing activities will involve the use of biological and
hazardous materials. Although we believe our safety procedures for handling
and
disposing of these materials comply with federal, state and local laws and
regulations, we cannot entirely eliminate the risk of accidental injury or
contamination from the use, storage, handling or disposal of these materials.
We
carry $1,000,000 casualty and general liability insurance policies. Accordingly,
in the event of contamination or injury, we could be held liable for damages
or
penalized with fines in an amount exceeding our resources and insurance
coverage, and our clinical trials or regulatory approvals could be
suspended.
We
may not be able to attract and retain highly skilled
personnel.
Our
ability to attract and retain highly skilled personnel is critical to our
operations and expansion. We face competition for these types of personnel
from
other pharmaceutical companies and more established organizations, many of
which
have significantly larger operations and greater financial, technical, human
and
other resources than us. We may not be successful in attracting and retaining
qualified personnel on a timely basis, on competitive terms, or at all. If
we
are not successful in attracting and retaining these personnel, our business,
prospects, financial condition and results of operations will be materially
and
adversely affected.
We
depend upon our senior management and their loss or unavailability could
put us
at a competitive disadvantage.
We
currently depend upon the efforts and abilities of our management team. The
loss
or unavailability of the services of any of these individuals for any
significant period of time could have a material adverse effect on our business,
prospects, financial condition and results of operations. We have not obtained,
do not own, nor are we the beneficiary of key-person life
insurance.
The
Company believes the following persons are critical to the success of the
Company as well as the terms of the employment agreements between them and
the
Company:
On
September 23, 2005, the Company entered into employment agreements with its
three executive officers, Eugene Seymour, Chief Executive Officer, Anil Diwan,
President and Chairman of the Board of Directors, and Leo Ehrlich, Chief
Financial Officer. All three agreements provide a minimum annual base salary
of
$200,000 for a term of three years. This base salary will increase to $250,000
per year upon closing of a financing to the Company with minimum gross proceeds
of $5,000,000. The Company is also obligated to pay health and life insurance
benefits and reimburse expenses incurred by the officers on behalf of the
company. Each
executive, if terminated by the Company without cause, would be entitled
to six
months severance pay in the amount of $100,000
.
There
are conflicts of interest among our officers, directors and
stockholders.
Certain
of our executive officers and directors and their affiliates are engaged
in
other activities and have interests in other entities on their own behalf
or on
behalf of other persons. Neither we nor any of our stockholders will have
any
rights in these ventures or their income or profits. In
particular:
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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.
|
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|
Our
executive officers or directors or their affiliates have interests
in
entities that
provide
products or services to us.
|
In
any of
these cases:
|
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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.
|
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|
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.
|
Leo
Ehrlich, our Chief Financial Officer and Director devotes only a portion
of his
time to the operation of our business, which may result in limited growth
and
success of our business. Additionally, Mr. Ehrlich and Anil Diwan own
collectively 75% of the capital stock of
TheraCour
Pharma, Inc. an approximately thirty-one percent (31%) shareholder and holder
of
the intellectual property rights the Company uses to conduct its
operations.
While
the
Company is not aware of any conflict that has arisen to date, Messrs. Diwan
and
Ehrlich may have conflicting fiduciary duties between the Company and TheraCour.
Currently, the Company does not have any policy in place to deal with such
should such a conflict arise.
We
may enter into contracts with various U.S. government agencies which have
special contracting requirements that give the government agency various
rights
or impose on the other party various obligations that can make the contracts
less favorable to the non-government party. Consequently, if a large portion
of
our revenue is attributable to these contracts, our business may be adversely
affected should the governmental parties exercise any of these additional
rights
or impose any of these additional obligations.
We anticipate
entering into contracts with various U.S. government agencies. In
contracting with government agencies, we will be subject to various federal
contract requirements. Future sales to U.S. government agencies will depend,
in
part, on our ability to meet these requirements, certain of which we may
not be
able to satisfy.
U.S.
government contracts typically contain unfavorable termination provisions
and
are subject to audit and modification by the government at its sole discretion,
which subjects us to additional risks. These risks include the ability of
the
U.S. government to unilaterally:
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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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|
terminate
our existing contracts;
|
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|
reduce
the scope and value of our existing contracts;
|
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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.
|
The
U.S.
government may terminate any of its contracts with us either for its convenience
or if we default by failing to perform in accordance with the contract schedule
and terms. Termination for convenience provisions generally enable us to
recover
only our costs incurred or committed, and settlement expenses and profit
on the
work completed prior to termination. Termination for default provisions do
not
permit these recoveries and make us liable for excess costs incurred by the
U.S.
government in procuring undelivered items from another source.
As
a U.S.
government contractor, we may become subject to periodic audits and reviews.
Based on the results of these audits, the U.S. government may adjust our
contract-related costs and fees, including allocated indirect costs. As part
of
any such audit or review, the U.S. government may review the adequacy of,
and
our compliance with, our internal control systems and policies, including
those
relating to our purchasing, property, compensation and/or management information
systems. In addition, if an audit or review uncovers any improper or illegal
activity, we may be subject to civil and criminal penalties and administrative
sanctions, including termination of our contracts, forfeiture of profits,
suspension of payments, fines and suspension or prohibition from doing business
with the U.S. government. We could also suffer serious harm to our reputation
if
allegations of impropriety were made against us. In addition, under U.S.
government purchasing regulations, some of our costs, including most financing
costs,
amortization of intangible assets, portions of our R&D costs and some
marketing expenses, may not be reimbursable or allowed under our contracts.
Further, as a U.S. government contractor, we may become subject to an increased
risk of investigations, criminal prosecution, civil fraud, whistleblower
lawsuits and other legal actions and liabilities to which purely private
sector
companies are not.
We
may fail to obtain contracts to supply the U.S. government, and we may be
unable
to commercialize our drug candidates.
The
U.S.
government has undertaken commitments to help secure improved countermeasures
against bio-terrorism. The process of obtaining government contracts is lengthy
and uncertain, and we must compete for each contract. Moreover, the award
of one
government contract does not necessarily secure the award of future contracts
covering the same drug. If the U.S. government makes significant future contract
awards for the supply of its emergency stockpile to our competitors, our
business will be harmed and it is unlikely that we will be able to ultimately
commercialize our competitive drug candidate.
In
addition, the determination of when and whether a drug is ready for large
scale
purchase and potential use will be made by the government through consultation
with a number of government agencies, including the FDA, the NIH, the CDC
and
the Department of Homeland Security. Congress has approved measures to
accelerate the development of bio-defense drugs through NIH funding, the
review
process by the FDA and the final government procurement contracting authority.
While this may help speed the approval of our drug candidates, it may also
encourage competitors to develop their own drug candidates
.
The
market for government stockpiling of H5N1 medicines is fairly new and
uncertain.
At
the
present many governments have already stockpiled influenza medicines for
H5N1.
We cannot predict with certainty the size of the market, if any. Consequently,
we cannot predict whether sales, if any, to governments will be sufficient
to
fund our business plan and commence revenue generating operations.
If
the U.S. government fails to continue funding bio-defense drug candidate
development efforts or fails to purchase sufficient quantities of any future
bio-defense drug candidate, we may be unable to generate sufficient revenues
to
continue operations.
We
hope
to receive funding from the U.S. government for the development of our
bio-defense drug candidates. Changes in government budgets and agendas, however,
may result in future funding being decreased and de-prioritized, and government
contracts typically contain provisions that permit cancellation in the event
that funds are unavailable to the government agency. Furthermore, we cannot
be
certain of the timing of any future funding, and substantial delays or
cancellations of funding could result from protests or challenges from third
parties. If the U.S. government fails to continue to adequately fund R&D
programs, we may be unable to generate sufficient revenues to continue
operations. Similarly, if we develop a drug candidate that is approved by
the
FDA, but the U.S. government does not place sufficient orders for this drug,
our
future business may be harmed.
Risks
Related to the Biotechnology/Biopharmaceutical Industry
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition. We may be unable
to
compete with enterprises equipped with more substantial resources than
us.
The
biotechnology and biopharmaceutical industries are characterized by rapid
technological developments and a high degree of competition based primarily
on
scientific and technological factors. These factors include the availability
of
patent and other protection for technology and products, the ability to
commercialize technological developments and the ability to obtain government
approval for testing, manufacturing and marketing.
Our
drugs
in development for influenza,
Flucide,
AviFluCide and FluCide HP would compete with neuraminidase inhibitors Tamiflu
and Relenza, anti-influenza drugs that are sold by Roche and Glaxo SmithKline
(GSK), respectively. Generic competitors include amantadine and rimantadine,
both oral tablets that only inhibit the replication of the influenza A virus.
BioCryst Pharmaceuticals, Inc. is developing injectable formulations of
peramivir, an influenza neuraminidase inhibitor, for the treatment of influenza,
which is currently in preclinical trials.
Our
HCV
and HIV drugs are at the earliest stage of development. There are a growing
number of anti-HIV and HVC drugs being sold or are in advanced stages of
clinical development. Companies with HCV and HIV products include Bristol-Myers
Squibb Company (BMS), Roche, Boehringer Ingelheim, Merck & Co., Inc.
(Merck), Abbott Laboratories, and Schering Plough, in addition to several
other
pharmaceutical and biotechnology firms.
We
compete with specialized biopharmaceutical firms in the United States, Europe
and elsewhere, as well as a growing number of large pharmaceutical companies
that are applying biotechnology to their operations. Many biopharmaceutical
companies have focused their development efforts in the human therapeutics
area,
including cancer. Many major pharmaceutical companies have developed or acquired
internal biotechnology capabilities or made commercial arrangements with
other
biopharmaceutical companies. These companies, as well as academic institutions,
government agencies and private research organizations, also compete with
us in
recruiting and retaining highly qualified scientific personnel and consultants.
Our ability to compete successfully with other companies in the pharmaceutical
field will also depend to a considerable degree on the continuing availability
of capital to us.
We
are
aware of numerous products under development or manufactured by competitors
that
are used for the prevention or treatment of certain diseases we have targeted
for drug development. Various companies are developing biopharmaceutical
products that potentially directly compete with our drug candidates even
though
their approach to such treatment is different.
We
expect
that our drug candidates under development and in clinical trials will address
major markets within the anti-viral sector. Our competition will be determined
in part by the potential indications for which drugs are developed and
ultimately approved by regulatory authorities. Additionally, the timing of
the
market introduction of some of our potential drugs or of competitors’ products
may be an important competitive factor. Accordingly, the relative speed with
which we can develop drugs, complete pre-clinical testing, clinical trials,
approval processes and
supply
commercial quantities to market are important competitive factors. We expect
that competition among drugs approved for sale will be based on various factors,
including product efficacy, safety, reliability, availability, price and
patent
protection.
The
successful development of biopharmaceuticals is highly uncertain. A variety
of
factors including, pre-clinical study results or regulatory approvals, could
cause us to abandon development of our drug
candidates.
Successful
development of biopharmaceuticals is highly uncertain and is dependent on
numerous factors, many of which are beyond our control. Products that appear
promising in the early phases of development may fail to reach the market
for
several reasons including:
·
|
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;
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·
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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;
|
·
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manufacturing
costs, pricing or reimbursement issues, or other factors that make
the
product not economical; and
|
·
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the
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
|
Success
in pre-clinical and early clinical studies does not ensure that large-scale
clinical studies will be successful. Clinical results are frequently susceptible
to varying interpretations that may delay, limit or prevent regulatory
approvals. The length of time necessary to complete clinical studies and
to
submit an application for marketing approval for a final decision by a
regulatory authority varies significantly from one product to the next, and
may
be difficult to predict.
Risks
Related to the Securities Markets and Investments in Our Common
Stock
Because
our common stock is traded on the "pink sheets," your ability to sell your
shares in the secondary trading market may be
limited.
Our
common stock is currently quoted on the National Quotation Bureau's "Pink
Sheets" and we expect that after the effectiveness of this registration
statement, our common stock will also be quoted in the over-the-counter market
on the OTC Electronic Bulletin Board. Consequently, the liquidity of our
common
stock is impaired, not only in the number of shares that are bought and sold,
but also through delays in the timing of transactions, and coverage by security
analysts and the news media, if any, of our company. As a result, prices
for
shares of our common stock may be lower than might otherwise prevail if our
common stock was quoted and traded on Nasdaq or a national securities
exchange.
Because
our shares are "penny stocks," you may have difficulty selling them in the
secondary trading market.
Federal
regulations under the Securities Exchange Act of 1934 regulate the trading
of
so-called "penny stocks," which are generally defined as any security not
listed
on a national securities exchange or Nasdaq, priced at less than $5.00 per
share
and offered by an issuer with limited net tangible assets and revenues. Since
our common stock currently is quoted on the "Pink Sheets" at less than $5.00
per
share, our shares are "penny stocks" and may not be traded unless a disclosure
schedule explaining the penny stock market and the risks associated therewith
is
delivered to a potential purchaser prior to any trade.
In
addition, because our common stock is not listed on Nasdaq or any national
securities exchange and currently is quoted at and trades at less than $5.00
per
share, trading in our common stock is subject to Rule 15g-9 under the Securities
Exchange Act. Under this rule, broker-dealers must take certain steps prior
to
selling a "penny stock," which steps include:
|
·
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obtaining
financial and investment information from the
investor;
|
|
·
|
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.
|
If
these
penny stock rules are not followed by the broker-dealer, the investor has
no
obligation to purchase the shares. The application of these comprehensive
rules
will make it more difficult for broker-dealers to sell our common stock and
our
shareholders, therefore, may have difficulty in selling their shares in the
secondary trading market.
Our
stock price may be volatile and your investment in our common stock could
suffer
a decline in value.
As
of
January 11, 2007, the last trade price of our common stock, as quoted on
the
"Pink Sheets", was $0.84. The price may fluctuate significantly in response
to a
number of factors, many of which are beyond our control. These factors
include:
|
·
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progress
of our products through the regulatory
process;
|
|
·
|
results
of preclinical studies and clinical
trials;
|
|
·
|
announcements
of technological innovations or new products by us or our
competitors;
|
|
·
|
government
regulatory action affecting our products or our competitors' products
in
both the United States and foreign
countries;
|
|
·
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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;
|
|
·
|
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.
|
A
registration of a significant amount of our outstanding restricted stock
may
have a negative effect on the trading price of our
stock.
At
September 30, 2006, shareholders of the Company had approximately 90 million
shares of restricted stock, or 80.3% of the outstanding common stock. If
we were
to file a registration statement including all of these shares, and the
registration is allowed by the SEC, these shares would be freely tradable
upon
the effectiveness of the planned registration statement. If investors holding
a
significant number of freely tradable shares decide to sell them in a short
period of time following the effectiveness of a registration statement, such
sales could contribute to significant downward pressure on the price of our
stock.
Our
directors and executive officers own or control a sufficient number of shares
of
our common stock to control our company, which could discourage or prevent
a
takeover, even if an acquisition would be beneficial to our
shareholders.
At
September 30, 2006, our directors and executive officers own or control
approximately 56% of our outstanding voting power. Accordingly, these
shareholders, individually and as a group, may be able to influence the outcome
of shareholder votes, involving votes concerning the election of directors,
the
adoption or amendment of provisions in our articles of incorporation and
bylaws
and the approval of certain mergers or other similar transactions, such as
sales
of substantially all of our assets. Such control by existing shareholders
could
have the effect of delaying, deferring or preventing a change in control
of our
company.
We
do not intend to pay any cash dividends in the foreseeable future and,
therefore, any return on your investment in our capital stock must come from
increases in the fair market value and trading price of the capital
stock.
We
have
not paid any cash dividends on our common stock and do not intend to pay
cash
dividends on our common stock in the foreseeable future. We intend to retain
future earnings, if any, for reinvestment in the development and expansion
of
our business. Any credit agreements, which we may enter into with institutional
lenders, may restrict our ability to pay dividends. Whether we pay cash
dividends in the future will be at the discretion of our board of directors
and
will be dependent upon our financial condition, results of operations, capital
requirements and any other factors that the board of directors decides is
relevant. Therefore, any return on your investment in our capital stock must
come from increases in the fair market value and trading price of the capital
stock.
We
may issue additional equity shares to fund the Company’s operational
requirements which would dilute your share
ownership.
The
Company's continued viability depends on its ability to raise capital. Changes
in economic, regulatory or competitive conditions may lead to cost increases.
Management may also determine that it is in the best interest of the Company
to
develop new services or products. In any such case additional financing is
required for the Company to meet its operational requirements. There can
be no
assurances that the Company will be able to obtain such financing on terms
acceptable to the Company and at times required by the Company, if at all.
In
such event, the Company may be required to materially alter its business
plan or
curtail all or a part of its operational plans as detailed further in
Management’s Discussion and Analysis in this Form 10-SB. While the Company
currently has no offers to sell it securities to obtain financing, sale or
the
proposed sale of substantial amounts of our common stock in the public markets
may adversely affect the market price of our common stock and our stock price
may decline substantially. In the event that the Company is unable to raise
or
borrow additional funds, the Company may be required to curtail significantly
its operational plans as further detailed in Requirements for Additional
Capital
in the Management Discussion and Analysis of this Form 10-SB.
The
Company is authorized to issue up to 300,000,000 total shares of Common Stock
without additional approval by shareholders. As of September 30, 2006, we
had
112,417,502 of common stock outstanding, and warrants and options convertible
to
5,445,000 shares of common stock outstanding.
Because
our common stock is traded only on the pink sheets, your ability to sell
your
shares in the secondary trading market may be
limited.
Our
common stock is quoted only on the Pink Sheets. Consequently, the liquidity
of
our common stock is impaired, not only in the number of shares that are bought
and sold, but also through delays in the timing of transactions, and coverage
by
security analysts and the news media, if any, of our company. As a result,
prices for shares of our common stock may be different than might otherwise
prevail if our common stock was quoted or traded on a national securities
exchange such as the New York Stock Exchange.
Large
amounts of our common stock will be eligible for resale under Rule 144.
As
of
January 11, 2007, approximately 90,311,770 of 112,417,502 issued and outstanding
shares of the Company’s common stock are restricted securities as defined under
Rule 144 of the Securities Act of 1933, as amended (the “Act”) and under certain
circumstances may be resold without registration pursuant to Rule 144.
Approximately
23,666,770 shares of our restricted shares of common stock are held by
non-affiliates who may avail themselves of the public information requirements
and sell their shares in accordance with Rule 144. As a result, some or all
of
these shares may be sold in accordance with Rule 144 potentially causing
the
price of the Company’s shares to decline.
In
general, under Rule 144, a person (or persons whose shares are aggregated)
who
has satisfied a one-year holding period may, under certain circumstances,
sell
within any three-month period a number of securities which does not exceed
the
greater of 1% of the then outstanding shares of common stock or the average
weekly trading volume of the class during the four calendar weeks prior to
such
sale. Rule 144 also permits, under certain circumstances, the sale of
securities, without any limitation, by a person who is not an Affiliate,
as such
term is defined in Rule 144(a)(1), of the Company and who has satisfied a
two-year holding period. Any substantial sale of the Company's common stock
pursuant to Rule 144 may have an adverse effect on the market price of the
Company’s shares. This filing will satisfy certain public information
requirements necessary for such shares to be sold under Rule 144.
The
requirements of complying with the Sarbanes-Oxley act may strain our resources
and distract management
We
are
subject to the reporting requirements of the Securities Exchange Act of 1934,
as
amended (the “Exchange Act”), and the Sarbanes-Oxley Act of 2002. the costs
associated with these requirements may place a strain on our systems and
resources. The Exchange Act requires that we file annual, quarterly and current
reports with respect to our business and financial condition. The Sarbanes-Oxley
Act requires that we maintain effective disclosure controls and procedures
and
internal controls over financial reporting. Historically, as a private company
we have maintained a small accounting staff, but in order to maintain and
improve the effectiveness of our disclosure controls and procedures and internal
control over financial reporting, significant additional resources and
management oversight will be required. This includes, among other things,
retaining independent public accountants. This effort may divert management’s
attention from other business concerns, which could have a material adverse
effect on our business, financial condition, results of operations and cash
flows. In addition, we may need to hire additional accounting and financial
persons with appropriate public company experience and technical accounting
knowledge, and we cannot assure you that we will be able to do so in a timely
fashion.
Our
executive officers, directors and principal stockholders control our business
and may make decisions that are not in our stockholders’ best
interests.
As
of
January
11, 2007
,
our
officers, directors, and principal stockholders, and their affiliates, in
the
aggregate, beneficially owned approximately 75% of the outstanding shares
of our
common stock on a fully diluted basis. As a result, such persons, acting
together, have the ability to substantially influence all matters submitted
to
our stockholders for approval, including the election and removal of directors
and any merger, consolidation or sale of all or substantially all of our
assets,
and to control our management and affairs. Accordingly, such concentration
of
ownership may have the effect of delaying, deferring or preventing a change
in
discouraging a potential acquirer from making a tender offer or otherwise
attempting to obtain control of our business, even if such a transaction
would
be beneficial to other stockholders.
Sales
of additional equity securities may adversely affect the market price of
our
common stock and your rights in the Company may be
reduced.
We
expect
to continue to incur drug development and selling, general and administrative
costs, and in order to satisfy our funding requirements, we may need to sell
additional equity securities. Our stockholders may experience substantial
dilution and a reduction in the price that they are able to obtain upon sale
of
their shares. Also, any new securities issued may have greater rights,
preferences or privileges than our existing common stock which may adversely
affect the market price of our common stock and our stock price may decline
substantially.
ITEM
2:
Management
Discussion and Analysis of Plan of Operation
The
following discussion contains forward-looking statements that involve risks
and
uncertainties.
Our
actual results could differ materially from those anticipated by the
forward-looking information. Factors that may cause such differences include,
but are not limited to, availability and cost of financial resources, results
of
our R&D efforts and clinical trials, product demand, market acceptance and
other factors discussed in this Form 10-SB under the heading “Risk Factors” This
managements discussion and analysis or plan of operation, should be read
in
conjunction with our financial statements and the related notes included
elsewhere in this Form 10-SB.
Introduction
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25,
2000
as Edot-com.com, Inc
.
and
was
organized for the purpose of conducting internet retail sales. On April 1,
2005,
Edot-com.com, Inc.
was
incorporated under the laws of the State of Nevada for the purpose of
re-domiciling the Company as a Nevada corporation, Edot-com.com (Nevada).
On
April 15, 2005, the Company and Edot-com.com (Nevada) were merged and
Edot-com.com, Inc.,
a
Nevada
corporation, became the surviving entity.
On
June
1, 2005, the Company acquired NanoViricide, Inc., a privately owned Florida
corporation (“NVI”), pursuant to an Agreement and Plan of Share Exchange (the
“Exchange”). NVI was incorporated under the laws of the State of Florida on May
12, 2005 and its sole asset was comprised of a licensing agreement with
TheraCour Pharma, Inc. (an approximately 31% shareholder of the Company)
for
rights to develop and commercialize novel and specifically targeted drugs
based
on TheraCour's targeting technologies, against a number of human viral diseases.
Upon consummation of the Exchange, the Company adopted the business plan
of NVI.
Pursuant
to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate
of
80,000,000 newly issued shares of ECMM common stock, resulting in an aggregate
of 100,000,000 shares of ECMM common stock issued and outstanding. As a result
of the Exchange, NVI became a wholly-owned subsidiary of ECMM. The ECMM shares
were issued to the NVI Shareholders on a pro rata basis, on the basis of
4,000
shares of the Company’s Common Stock for each share of NVI common stock held by
such NVI Shareholder at the time of the Exchange.
On
June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, Edot-com.com, Inc. changed
its name to NanoViricides, Inc. and its stock symbol on the Pink Sheets to
“NNVC”, respectively.
For
financial accounting purposes, this acquisition was a reverse acquisition
of the
Company by NanoViricide (NVI), under the purchase method of accounting, and
was
treated as a recapitalization with NanoViricide as the acquirer. Accordingly,
our historical financial statements have been prepared to give retroactive
effect to May 12, 2005 (date of inception), of the reverse acquisition completed
on June 1, 2005, and represent the operations of NanoViricides. With the
acquisition of NanoViricide, we no longer remained an inactive entity and
entered the pharmaceuticals business.
The
Company is considered a development stage company at this time.
Management’s
Plan of Operation
The
Company’s drug development business model was formed in May 2005 with a license
to the patents and intellectual property held by Theracour Pharma, Inc.,
that
enabled creation of drugs engineered specifically to combat viral diseases
in
humans. T
his
exclusive license from Theracour Pharma serves as a foundation for our
intellectual property.
The
Company was granted a worldwide exclusive perpetual license to this technology
for several drugs with specific targeting mechanisms
in
perpetuity
for the treatment of the following human viral diseases: Human Immunodeficiency
Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies,
Herpes Simplex Virus (HSV), Influenza and Asian Bird Flu Virus.
To
date,
we have engaged in organizational activities; sourcing compounds and materials;
and experimentation with studies on cell cultures and animals. We have generated
funding through the issuances of debt and private placement of common stock.
W
e
have
not generated any revenues and we do not expect to generate revenues in the
near
future. We may not be successful in developing our drugs and start selling
our
products when planned, or that we will become profitable in the future. We
have
incurred net losses in each fiscal period since inception of our
operations.
In
December 2005, we closed a $1,000,000 investment via a private placement
of
convertible debt to accredited investors which was converted in July 2006
into
3,333,333 shares of the Company’s common stock; in December 2005 we secured a
$1,370,000 investment via a private placement to accredited investors of
2,740,000 shares of the Company’s common stock; and in June 2006 we secured a
$1,875,000 investment via a private placement to accredited investors of
1,875,000 shares of the Company’s common stock. (See Part II, Item
4)
I
n
December 2005, the Company signed a Memorandum of Understanding with the
National Institute of Hygiene and Epidemiology in Hanoi (NIHE), a unit of
the
Vietnamese Government’s Ministry of Health. This Memorandum of Understanding
calls for cooperation in the development and testing of certain nanoviricides.
The parties agreed that the initial target would be the development of drugs
against H5N1 (avian influenza). NIHE thereafter requested that we develop
a drug
for rabies, a request to which we agreed. The initial phase of this agreement
called first for laboratory testing, followed by animal testing of several
drug
candidates developed by the Company. Preliminary laboratory testing of
FluCide™-I, AviFluCide-I™ and AviFluCide-HP™ were successfully performed at the
laboratories of the National Institute of Hygiene and Epidemiology in Hanoi
(NIHE). The second phase of the project, animal testing of the Influenza
and
H5N1 candidates as well as that of RabiCide-I™, the company’s rabies drug, is
expected to commence during the first quarter of 2007. The H5N1 testing will
utilize the NIHE’s BSL3 (biological safety laboratory level 3) laboratory that
is at the NIHE. Rabies testing can safely be done at their BSL2 facility.
A copy
of the Memorandum of Understanding is attached as an Exhibit to this Form
10-SB/A.
Management
believes that it has achieved significant milestones in the development of
anti-influenza drugs for human influenza (H1N1) and bird flu (H5N1).
Management’s beliefs are based on results of pre-clinical cell culture studies
and in vivo animal studies using mice.
Preclinical
Safety And Efficacy Studies
We
have
completed initial safety studies on the major constituent of our anti-viral
drug, FluCide-I™. The polymer, which is unique and proprietary to NanoViricides,
was tested for any toxic symptoms or for any ill effects in laboratory animals.
The preliminary results were successful. Additional laboratory data from
the
safety studies on the base polymer material were performed. This data included
blood test results, as well as histological (microscopic) examinations of
various organs. These studies showed that the polymer used to construct the
nanomicelle caused no organic damage to the test animals. All results were
within safe limits.
As
a test
case, we have developed and evaluated nanoviricides against influenza and
H5N1
(one of the highly pathogenic avian influenza subtypes for safety and efficacy.
In vitro (laboratory) evaluation of 14 substances, including controls, for
protection of mammalian cells against infection by the H5N1 subtype. These
assays were conducted in Vietnam under the auspices of the National Institute
of
Hygiene and Epidemiology, Hanoi (NIHE) under the VietNam Ministry of Health.
We
identified four different nanoviricides as being highly effective against
H5N1
using two different assays (both involving cell culture, one using the plaque
reduction method and the other involving microscopic examination to determine
the extent of cytopathic events (CPE) reduction. All of these were effective
at
extremely low concentrations and thus are expected to be drug
candidates.
The
best
of these was a nanoviricide based on an antibody fragment as the targeting
ligand, which led to near complete suppression of
cytopathic
effects
(CPE) at
an extraordinarily low concentration level. This is being developed as
AviFluCide-I™, a drug highly specific to H5N1 that is being developed against
the Vietnam strain and is expected to also work against the Indonesian strain
(although further studies will be required to determine its efficacy against
various other highly pathogenic strains of avian influenza).
Another
nanoviricide which is based on a ligand that we designed in-house to be specific
to the group of all or a majority of highly pathogenic avian influenza viruses,
also showed a very high efficacy (group-level specificity). This is being
developed as “AviFluCide-HP™”, a drug that is group-specific against emergent
and existing highly pathogenic influenza viruses (including H5N1, H7Nx and
others).
A
third
nanoviricide based on a ligand that we designed for attacking all influenza
A
viruses (type-level specificity) showed strong efficacy against H5N1 as well.
This is being developed as “FluCide-I™”, a drug designed primarily for use
against serious cases of human influenza.
It
should
be noted that all of our studies to date were preliminary. Thus, the evidence
we
have developed is indicative, but not considered confirmative, of the
capabilities of the nanoviricides technology's potential. With the success
of
these preliminary studies, the Company has decided to perform further
pre-clinical studies that validate safety and efficacy of its materials and
its
anti-viral drugs FluCide™ and AviFluCide™. Management intends to use capital and
debt financing to enable the completion of these goals.
Requirement
for Additional Capital
We
currently do not have sufficient cash reserves to meet all of our anticipated
obligations for the next twelve months and we may not be able to obtain the
necessary financing.
As
of
September 30, 2006 we have a cash balance of approximately $1,777,000 which
can
support operations through March 2007. We expect we will require in excess
of
$5,000,000 to execute the first part of our business plan which covers twelve
months of operations.
Assuming
that we are successful in raising additional financing, we anticipate that
we
will incur the following expenses over the next twelve months:
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™,
AviFluCide™, FluCide HP™, and Rabies planned for Q1 2007. 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 Hepatitis
C
(HCV) for which we have budgeted $300,000.
|
|
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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 first calendar quarter of 2007 show improvement
over
present treatments.
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|
4
|
Staffing
costs of $1,500,000: The Company expects to incur these costs if
the
planned trials in the first calendar quarter of 2007 show improvement
over
the present baseline treatments. 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.
|
The
Company will be unable to proceed with its planned drug development, meet
its
administrative expense requirements, capital costs, or staffing costs without
obtaining additional financing of approximately $3,000,000 to meet its
$5,000,000 budget. The Company does not have any arrangements at this time
for
equity or other financings. If we are unable to obtain additional financing,
our
business plan will be significantly delayed.
Research
and Development Costs
The
Company does not maintain separate accounting line items for each project
in
development. The Company maintains aggregate expense records for all research
and development conducted, and allocates expenses across all projects at
each
period-end for purposes of providing accounting basis for each project as
required under Section VIII-for Companies Engaged in Research and Development
Activities. The following expenses were incurred during the periods presented
in
this Form 10-SB.
|
|
Three
Months
Ended
September
30, 2006
|
|
Three
Months
Ended
September
30, 2005
|
|
For
the Cumulative
Period
From
May 12, 2005
(Inception)
through
September
30, 2006
|
|
Research
and development
|
|
|
184,885
|
|
|
125,088
|
|
|
1,115,547
|
|
|
|
Year
Ended
June
30. 2006
|
|
For
the Period
From
May 12,
2005
(Inception)
through
June
30,
2005
|
|
For
the Cumulative
Period
From
May 12, 2005
(Inception)
through
June
30, 2006
|
|
Research
and development
|
|
|
899,891
|
|
|
30,771
|
|
|
930,662
|
|
Time
Schedules, Milestones and Development Costs
In
the
event that funding can be achieved, we shall endeavor to achieve completion
of
the following events within the next twelve months:
The
status of each of our major research and development projects is as
follows:
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 on 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 first calendar
quarter of 2007.
|
Nature,
timing and estimated costs
|
We
expect to know by the end of March 2007 whether we will continue
with
FluCide-I as a drug candidate. The Company has budgeted approximately
$300,000 for the material development, production and testing of
this drug
during the first calendar quarter of 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 $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.
|
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 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. 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
first
calendar quarter of 2007.
|
Nature,
timing and estimated costs
|
We
expect to know by the end of March 2007 whether we will continue
with
AviFluCide as a drug candidate. The Company has budgeted approximately
$300,000 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 $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.
|
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 bind to cells. This mechanism involves the hemagglutinin
coat protein of influenza virus binding to sialic acids on cell
surfaces.
FluCideHP has been tested in cell cultures 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) during the first calendar quarter of
2007.
|
Nature,
timing and estimated costs
|
We
expect to know by the end of March 2007 whether we will continue
with
FluCide-I as a drug candidate. The Company has budgeted approximately
$300,000 for the material development, production and testing of
this drug
during the first calendar quarter of 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
$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.
|
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 influenza viruses bind to cells. This mechanism involves
the
hemagglutinin coat protein of influenza virus binding to sialic
acids on
cell surfaces.
RabiCide
has never been tested. 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
the first calendar quarter of 2007.
|
Nature,
timing and estimated costs
|
We
expect to know by the end of March 2007 whether we will continue
with
RabiCide
as
a drug candidate. The Company has budgeted approximately $300,000
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 $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.
|
Other
drug nanoviricides for HCV and HIV diseases are at a very early stage of
research and development and involve a substantial amount of uncertainty
as to
the development of these drugs. At this time, very little resources have
been
allocated to these drugs. However should the clinical trials at NIHE in the
first calendar quarter of 2007 of our influenza and rabies drugs meet
managements expectations, HCV and HIV will become a major priority for
development in the following year.
The
Company has limited experience with pharmaceutical drug development. Thus,
our
budget estimates are not based on experience, but rather based on advice
given
by our associates and consultants. As such these budget estimates may not
be
accurate. In addition, the actual work to be performed is not known at this
time, other than a broad outline, as is normal with any scientific work.
As
further work is performed, additional work may become necessary or change
in
plans or workload may occur. Such changes may have an adverse impact on our
estimated budget. Such changes may also have an adverse impact on our projected
timeline of drug development.
The
Company is currently engaged in a national search for an R&D as well as
manufacturing facility. The manufacturing portion of the facility will
eventually need to be certified by the FDA in order for the Company to produce
experimental materials that can be sent to outside scientists for
pharmaco-kinetic, pharmaco-dynamic and toxicology studies. These three sets
of
studies must be completed prior to the Company filing an IND with the FDA
to
begin the human safety and efficacy trials (Phase I , II and III ).
The
work-plan we have developed for the next twelve months is expected to enable
us
to file an investigational new drug application in our 2007-2008 fiscal year.
This work-plan is expected to reduce certain risks of drug development. We
believe that this coming year's work-plan will lead us to obtain certain
information about the safety and efficacy of some of the drugs under development
in animal models. If our studies are not successful, we will have to develop
additional drug candidates and perform further studies. If our studies are
successful, then we expect to be able to undertake further studies in animal
models to obtain necessary data regarding the pharmaco-kinetic and
pharmaco-dynamic profiles of our drug candidates. We believe these data will
then enable us to file an Investigational New Drug (IND) application, towards
the goal of obtaining FDA approval for testing the drugs in human patients.
Most
pharmaceutical companies expect 4 to 10 years of study to be needed before
a
drug candidate reaches the IND stage. We believe that because we are working
in
the infectious agents area, our studies will have objective response end
points,
and will be of relatively short durations. Our business plan is based on
these
assumptions. If we find that we have underestimated the time duration of
our
studies, or we have to undertake additional studies, due to various reasons
within or outside of our control, this will grossly and adversely impact
both
our timelines and our financing needs.
Management
intends to use capital and debt financing, as required, to fund the Company’s
operations. There can be no assurance that the Company will be able to obtain
the additional capital resources necessary to fund its anticipated obligations
for the next twelve months.
The
Company is considered to be a development stage company and will continue
in the
development stage until generating revenues from the sales of its products
or
services. As a result, the report of the independent registered public
accounting firm on our financial statements as of June 30, 2006, contains
an
explanatory paragraph regarding a substantial doubt about our ability to
continue as a going concern.
Critical
Accounting Policies
Our
management’s discussion and analysis or plan of operation is based upon our
financial statements, which have been prepared in accordance with generally
accepted accounting principles in the United States, or GAAP. The preparation
of
these financial statements requires us to make estimates and judgments that
affect the reported amounts of our assets, liabilities, revenues, expenses
and
other reported disclosures. We base our estimates on historical experience
and
on various other assumptions that we believe are reasonable under the
circumstances.
The
notes
to our financial statements include disclosure of our significant accounting
policies. While all decisions regarding accounting policies are important,
we
believe that the following policies could be considered
critical.
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.
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.
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 three months
ended September 30, 2006, and year ended June 30, 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).
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 as they were for
past
services, or expensed over the service period for future services.
Recent
Accounting Pronouncements
The
FASB
has issued Interpretation No. 46 (FIN-46R) (Revised December 2003),
Consolidation
of Variable Interest Entities
.
FIN-46R
clarifies the application of Accounting Research Bulletin No. 51, “Consolidated
Financial Statements,” to certain entities in which equity investors do not have
the characteristics of a controlling financial interest or do not have
sufficient equity at risk for the entity to finance its activities without
additional subordinated financial support from other parties. It separates
entities into two groups: (1) those for which voting interests are used to
determine consolidation and (2) those for which variable interests are used
to
determine consolidation (the subject of FIN-46R). FIN-46R clarifies how to
identify a variable interest entity and how to determine when a business
enterprise should include the assets, liabilities, non-controlling interests,
and results of activities of a variable interest entity in its consolidated
financial statements.
FIN-46R
requires that a variable interest entity to be consolidated by its “Primary
Beneficiary.” The Primary Beneficiary is the entity, if any, that stands to
absorb a majority of the variable interest entity’s expected losses, or in the
event that no entity stands to absorb a majority of the expected losses,
then
the entity that stands to receive a majority of the variable interest entity’s
expected residual returns. If it is reasonably possible that an enterprise
will
consolidate or disclose information about a variable interest entity when
FIN-
46R becomes effective, the enterprise is required to disclose in all financial
statements initially issued after December 31, 2003, the nature, purpose,
size,
and activities of the variable interest entity and the enterprise’s maximum
exposure to loss as a result of its involvement with the variable interest
entity. For all periods presented, the Company evaluated its relationship
with
TheraCour Pharma, Inc. for purposes of FIN-46R, and concluded that it is
not a
variable interest entity that is subject to consolidation in the Company’s
financial statements
under
FIN-46R.
In
December 2004, the FASB issued Statement of Financial Accounting Standards
("SFAS") No. 123 (revised 2004), Share-Based Payment ("SFAS No. 123-R").
SFAS
No.123-R is a revision of SFAS No. 123, as amended, Accounting for Stock-Based
Compensation, and supersedes Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees. SFAS No.123-R eliminates the
alternative to use the intrinsic value method of accounting that was provided
in
SFAS No. 123, which generally resulted in no compensation expense recorded
in
the financial statements related to the issuance of equity awards to employees.
SFAS No. 123-R requires that the cost resulting from all share based payment
transactions be recognized in the financial statements. SFAS No. 123-R
establishes fair value as the measurement objective in accounting for
share-based payment arrangements and requires all companies to apply a
fair-value-based measurement method in accounting for generally all share-based
payment transactions with employees. The Company adopted this statement using
the modified prospective transition method for awards made to employee and
directors, which required the application of the accounting standard as of
May
12, 2005 (date of inception).
In
May
2005, the FASB issued Statement No. 154, "Accounting Changes and Error
Corrections", a replacement of Accounting Principles Board Opinion No. 20,
"Accounting Changes", and Statement No. 3, "Reporting Accounting Changes
in
Interim Financial Statements" ("SFAS 154"). SFAS 154 changes the requirements
for the accounting for, and reporting of, a change in accounting principle.
Previously, voluntary changes in accounting principles were generally required
to be recognized by way of a cumulative effect adjustment within net income
during the period of the change. SFAS 154 requires retrospective application
to
prior periods' financial statements, unless it is impracticable to determine
either the period of specific effects or the cumulative effect of the change.
SFAS 154 is effective for accounting changes made in fiscal years beginning
after December 15, 2005; however, the statement does not change the transition
provisions of any existing accounting pronouncements. The Company does not
believe adoption of SFAS 154 will have a material effect on its financial
position, cash flows or results of operations.
In
February 2006, the FASB issued Statement of Financial Accounting Standards
No.
155, "Accounting for Certain Hybrid Financial Instruments" ("SFAS 155"),
which
amends SFAS No. 133, "Accounting for Derivatives Instruments and Hedging
Activities" ("SFAS 133") and SFAS No. 140, "Accounting for Transfers and
Servicing of Financial Assets and Extinguishment of Liabilities" ("SFAS 140").
SFAS 155 amends SFAS 133 to narrow the scope exception for interest-only
and
principal-only strips on debt instruments to include only such strips
representing rights to receive a specified portion of the contractual interest
or principle cash flows. SFAS 155 also amends SFAS 140 to allow qualifying
special-purpose entities to hold a passive derivative financial instrument
pertaining to beneficial interests that itself is a derivative instruments.
The
Company is currently evaluating the impact this new Standard, but believes
that
it will not have a material impact on the Company's financial
position.
In
September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (“SFAS No.
157”). SFAS No.157 defines fair value, establishes a framework for measuring
fair value and expands disclosures about fair value measurements. SFAS No.
157
is effective for the Company beginning with fiscal year 2009. The Company
is in
the process of assessing the effect SFAS No. 157 may have on its financial
statements.
On
September 29, 2006, the FASB issued FASB Statement No. 158, "Employers'
Accounting for Defined Benefit Pension and Other Postretirement Plans --
An
Amendment of FASB Statements No. 87, 88, 106, and 132R" ("SFAS 158"). This
new
standard requires an employer to: (a) recognize in its statement of financial
position an asset for a plan's overfunded status or a liability for a plan's
underfunded status; (b) measure a plan's assets and its obligations that
determine its funded status as of the end of the employer's fiscal year (with
limited exceptions); and (c) recognize changes in the funded status of a
defined
benefit postretirement plan in the year in which the changes occur. Those
changes will be reported in comprehensive income. The requirement to recognize
the funded status of a benefit plan and the disclosure requirements are
effective for the Company's fiscal year ending June 30, 2007. The requirement
to
measure plan assets and benefit obligations as of the date of the employer's
fiscal year-end statement of financial position is effective for fiscal years
ending after December 15, 2008. The Company has determined that the effect,
of
the adoption of SFAS 158 will not be material to the Company’s financial
position and results of operations.
On
July
13, 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty
in
Income Taxes—an interpretation of FASB Statement No. 109. Interpretation 48
clarifies the accounting for uncertainty in income taxes recognized in an
entity’s financial statements in accordance with Statement 109 and prescribes a
recognition threshold and measurement attribute for financial statement
disclosure of tax positions taken or expected to be taken on a tax return.
Additionally, Interpretation 48 provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. Interpretation 48 is effective for fiscal years
beginning after December 15, 2006, with early adoption permitted. We are
currently evaluating whether the adoption of Interpretation 48 will have
a
material effect on our consolidated financial position, results of operations
or
cash flows.
Off-Balance
Sheet Arrangements
We
have
not entered into any off-balance sheet arrangements as of September 30, 2006.
ITEM
3.
DESCRIPTION OF PROPERTY.
Description
of Property
The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 1,500 square feet of office
space
at a base monthly rent of $1,875. The lease expires February 2007.
We
subcontract the laboratory research and development work to TheraCour Pharma,
Inc. which has a 2,500 square foot laboratory in the same building. Management
believes that the space is sufficient for the Company to monitor the
developmental progress at its subcontractors.
The
company is currently engaged in a national search for an R&D as well as
manufacturing facility. The manufacturing portion of the facility will
eventually have to be certified by the FDA in order for the Company to produce
experimental materials that can be sent to outside scientists for
pharmaco-kinetic, pharmaco-dynamic and toxicology studies. These three sets
of
studies must be completed prior to the Company filing an IND with the FDA
to
begin the human safety and efficacy trials (Phase I and Phase II).
ITEM
4.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT.
The
following table sets forth information relating to the beneficial ownership
of
the Company's common stock by those persons beneficia1ly holding more than
5% of
the Company's common stock, by the Company's directors and executive officers,
and by all of the Company's directors and executive officers as a group as
of
September 30, 2006.
Name
and Address of Beneficial Owner
|
Amount
and Nature of Beneficial Owner (1)
|
Percent
of Class (2)
|
Theracour
Pharma, Inc.(3) (4)
135
Wood Street
West
Haven, CT 06516
|
35,370,000
|
31.46%
|
Anil
Diwan (3) (4)
135
Wood Street
West
Haven, CT 06516
|
10,333,333
|
9.16%
|
Eugene
Seymour (5)
135
Wood Street
West
Haven, Connecticut 06516
|
8,750,000
|
7.77%
|
Leo
Ehrlich (4) (6)
135
Wood Street
West
Haven, Connecticut 06516
|
9,100,000
|
8.08%
|
Total
Business Services, Inc. (7)
c/o
Levy & Boonshoft, P.C.
477
Madison Avenue
New
York, New York 10022
|
8,834,000
|
7.86%
|
All
Directors and Executive
Officers
as a Group (3 persons) (8)
|
63,553,333
|
56.12%
|
(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 112,417,502 shares of Common Stock outstanding as of
September
30 2006, 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
333,333 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. Leo Ehrlich, the Company’s Chief
Financial Officer, serves as TheraCour’s Director and owns 10% of the
outstanding capital stock of TheraCour. Anil Diwan has 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 Mr. Seymour
and
250,000 shares of NanoViricides common stock issuable upon exercise
of
options held by Mr. Seymour that are currently exercisable or will
become
exercisable within 60 days.
|
(6)
|
Leo
Ehrlich, Chief Financial Officer and Director. Includes 5,850,000
shares
of NanoViricides common stock held by Mr. Ehrlich and includes
3,000,000
shares of NanoViricides common stock held by the wife and children
of Leo
Ehrlich, and 250,000 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
3,000,000 shares of Common Stock owned by the children of John
Flynn, the
sole officer and director of Total Businesses Services,
Inc.
|
(8)
|
Includes
3,000,000 shares of Common Stock indirectly owned by certain of
the
Executive Officers and Directors as a group but excludes non vested
options to acquire an additional 1,166,667 shares of Common Stock
by
Executive Officers and Directors, as a
group.
|
ITEM
5. DIRECTORS AND EXECUTIVE OFFICERS, PROMOTERS AND CONTROL
PERSONS.
Name
|
Age
|
Title
|
|
|
|
Anil
Diwan, PhD.
|
47
|
President;
Chairman of the Board
|
Eugene
Seymour, MD, MPH
|
65
|
Chief
Executive Officer; Director
|
Leo
Ehrlich, CPA
|
48
|
Chief
Financial Officer; Director
|
The
Company’s executive officers and directors are elected annually and serve until
the next annual meeting of stockholders.
Eugene
Seymour, MD, MPH,
age 65,
has been Chief Executive Officer (CEO) and a director of the Company since
consummation of the merger on June 1, 2005. From 1996 until May 2005 he has
been
a private investor and has held no corporate positions. During this period
he
formed a non-profit foundation which funded both testing and training programs
for health workers in Asia and Africa. He was a consultant to the UN Global
Program on AIDS and was sent to several countries, (Lithuania, Latvia, Estonia
and Russia) to interact with local physicians and assist them in setting
up
testing programs. Dr. Seymour obtained a Master's degree in the Epidemiology
of
Infectious Diseases at UCLA in addition to his medical degree. He began clinical
practice in Internal Medicine and joined the UCLA Medical School faculty.
He
left UCLA after two years and joined the USC faculty as Associate Professor.
Dr.
Seymour served in the Medical Corps of US Army Reserve during the Vietnam
era
and attained the rank of Major. In 1986, he was requested by the US government
to establish a testing laboratory and run a large-scale surveillance program
for
HIV prevalence in the Hispanic population in Los Angeles. His laboratory
ended
up testing over 50,000 people. In 1989, he founded StatSure Diagnostic Systems,
Inc. (SDS) (formerly Saliva Diagnostic Systems, Inc.), raised capital and
developed the rapid HIV antibody blood test (Hema-Strip). He took the company
public in 1993 as CEO and President. He left SDS in 1996. Dr. Seymour holds
8
issued patents, and is married with three children, two of whom are physicians.
Anil
Diwan, PhD,
age 47,
has been President and the Chairman of the Board of Directors of the Company
since consummation of the merger on June 1, 2005. Dr. Diwan simultaneously
therewith and since its formation, has also served as the Chief Executive
Officer and Director of All Excel, Inc.
(from
1995 to the present)
and
TheraCour Pharma, Inc. (from 2004 to the present) and is the original inventor
of the technologies licensed to NanoViricides Inc, as well as the TheraCour
polymeric micelle technologies and products based on them. Since 1992, he
has
researched and developed TheraCour nanomaterials. Dr. Diwan was the first
to
propose the development of novel pendant polymers for drug delivery that
led to
an explosion of research in pharmacological applications of polymeric micelles.
Anil has won over 12 NIH SBIR grants. Dr. Diwan holds two patents, one issued
and one applied for, and has made intellectual property depositions of four
additional patentable discoveries with the patent attorney. Dr. Diwan has
held
several scholastic distinctions, including an All-India 9th rank on the Joint
Entrance Examination of all IIT’s. He holds a Ph.D. in Biochemical Engineering
from Rice University (1986) and B.S. in Chemical Engineering from Indian
Institute of Technology (IIT) Bombay (1980).
Leo
Ehrlich, CPA,
age 48,
has been Chief Financial Officer (CFO) and a director of the Company since
consummation of the merger on June 1, 2005
.
From
October 8, 1999 to the present time, Mr. Ehrlich has been a Director at StatSure
Diagnostic Systems, Inc. and has held different executive officer positions
at
that company including CEO, President, and his current title of CFO. From
January 1998 to September 1999, he was president of Immmu Inc., a privately
held
vitamin company. Mr. Ehrlich is a Certified Public Accountant and received
his
BBA from Bernard Baruch College of the City University of New York.
AUDIT
COMMITTEE
Although
its By-laws provide for the appointment of one, the Company is not yet required
to have an Audit Committee as a result of the fact that our common stock
is not
considered a “listed security” as defined in Rule 10A-3 of the Exchange Act.
There are currently no audit committee members that meet the criteria of
“Financial Expert”, however the company is actively working to appoint a
“Financial Expert” in the current year.
CODE
OF ETHICS
We
have
adopted a code of ethics meeting the requirements of Section 406 of the
Sarbanes-Oxley Act of 2002. We believe our code of ethics is reasonably designed
to deter wrongdoing and promote honest and ethical conduct; provide full,
fair,
accurate, timely and understandable disclosure in public reports; comply
with
applicable laws; ensure prompt internal reporting of violations; and provide
accountability for adherence to the provisions of the code of ethic. Our
code of
ethics is filed as an exhibit to this Form 10-SB.
ITEM
6.
EXECUTIVE COMPENSATION
.
The
following table reflects all forms of compensation for the year ended June
30,
2006 and for the period from May 12, 2005 (date of inception) through June
30,
2005. No other person received salary or bonus in excess of $100,000 for
any of
these fiscal years.
Summary
Compensation Table
|
|
|
|
Annual
Compensation
|
|
Long-Term
Compensation
|
|
|
|
|
|
Name
and Principal Position
|
|
Year
|
|
Salary
|
|
Bonus
|
|
Other
Annual Compensation
|
|
Restricted
Stock Award(s) ($)
|
|
Securities
Underlying Options/SARs (#)
|
|
LP
Payouts
($)
|
|
All
Other Compensation($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eugene
Seymour,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CEO,
Director
|
|
|
2006
|
|
$
|
150,000
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
500,000
|
|
|
|
|
$
|
-
|
|
|
|
|
2005
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
-
|
|
|
|
|
$
|
-
|
|
|
|
|
2004
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
-
|
|
|
|
|
$
|
-
|
|
Anil
Diwan,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
President,
Director
|
|
|
2006
|
|
$
|
150,000
|
|
$
|
211,000
|
|
$
|
-
|
|
$
|
-
|
|
|
1,000,000
|
|
|
|
|
$
|
-
|
|
|
|
|
2005
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
-
|
|
|
|
|
$
|
-
|
|
|
|
|
2004
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
-
|
|
|
|
|
$
|
-
|
|
Leo
Ehrlich
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CFO,
Director
|
|
|
2006
|
|
$
|
150,000
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
500,000
|
|
|
|
|
$
|
-
|
|
|
|
|
2005
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
-
|
|
|
|
|
$
|
-
|
|
|
|
|
2004
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
-
|
|
|
|
|
$
|
-
|
|
The
following table sets forth certain information regarding stock options granted
to the named executive officers from May 12, 2005 (date of inception) through
June 30, 2005. No options were granted to officers for the three month period
ending September 30, 2006.
Individual
Grants
|
Name
|
Number
of
Securities
Underlying
Options/SARs
Granted
(#)
|
Percentage
of
Total
ptions/SARs
Outstanding
|
Exercise
or
Base
Price
(#/Sh)
|
Expiration
Date
|
Eugene
Seymour
|
500,000
(1)
|
25%
|
0.10
|
9/26/15
|
Anil
Diwan
|
1,000,000
(2)
|
50%
|
0.10
|
9/26/15
|
Leo
Ehrlich
|
500,000
(3)
|
25%
|
0.10
|
9/26/15
|
(1)
Stock
Option Agreement, dated September 26, 2005, between the Company and Dr. Seymour
for a purchase price of $0.10 per share.
(2)
Stock
Purchase Agreement, dated September 26, 2005 between the Company and Dr.
Diwan
for a purchase price of $0.10 per share.
(3)
Stock
Purchase Agreement, dated September 26, 2005 between the Company and Mr.
Erhlich
for a purchase price of $0.10 per share.
There
were no options exercised by the named executive officers in the last fiscal
year.
EMPLOYMENT
AGREEMENTS
On
September 26, 2005, the Company entered into employment agreements with its
three executive officers, Eugene Seymour, Chief Executive Officer, Anil Diwan,
President and Chairman of Board, and Leo Ehrlich, Chief Financial Officer.
All
three agreements provide a minimum annual base salary of $200,000 for a term
of
three years. This base salary will increase to $250,000 per year upon closing
of
a financing to the Company with minimum gross proceeds of $5,000,000. The
Company is also obligated to pay health and life insurance benefits and
reimburse expenses incurred by the officers on behalf of the company.
Each
executive, if terminated by the Company without cause, would be entitled
to six
months severance pay in the amount of $100,000
.
Additionally the agreements provided the following stock options:
|
·
|
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
(333,333
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.
|
|
·
|
Leo
Ehrlich 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.
|
COMPENSATION
OF DIRECTORS
At
this
time, directors receive no remuneration for their services as directors of
the
Company, nor does the Company reimburse directors for expenses incurred in
their
service to the Board of Directors. The Company does not expect to pay any
fees
to its directors for the 2007 fiscal year.
COMPENSATION
OF SCIENTIFIC ADVISORY BOARD
The
Company anticipates holding four Scientific Advisory Board meetings per annum.
As compensation, each member of the Scientific Advisory Board (SAB) will
be
granted each quarter 10,000 warrants to purchase the Company’s common stock at
120% of the Company’s closing stock quote on the day following the meeting.
Should the Company not call a quarterly meeting, quarterly options will be
granted on May 15, August 15, November 15, and February 15. The warrants
will
have a four year expiration date. In addition the Company will reimburse
each
SAB member for travel and other out-of-pocket expenses incurred in the course
of
performing their services. Through September 30, 2006, the SAB was granted
a
total of 200,000 stock warrants exercisable into common shares at prices
from
$0.18 to $2.20 per share.
ITEM
7. CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS
Currently,
we have no independent directors on our Board of Directors, and therefore
have
no formal procedures in effect for reviewing and pre-approving any transactions
between us, our directors, officers and other affiliates. We will use our
best
efforts to insure that all transactions are on terms at least as favorable
to
the Company as we would negotiate with unrelated third parties.
TheraCour
Pharma, Inc.
On
May
12, 2005, the Company entered into an Material License Agreement, amended
as of
January 8, 2007 (the “License”) we entered into with TheraCour Pharma, Inc.,
(“TheraCour”), our largest shareholder. As of the present, TheraCour granted the
Company an exclusive license in perpetuity for technologies developed by
TheraCour for six virus types: HIV, HCV, Herpes, Rabies, Asian (bird) flu
and
Influenza. In consideration for obtaining this exclusive license, we agreed:
(1)
that TheraCour can charge its costs (direct and indirect) plus no more than
30%
of direct costs as a development fee and such development fees shall be due
and
payable in periodic installments as billed, (2) to pay $25,000 per month
for
usage of lab supplies and chemicals from existing stock held by TheraCour;
(3)
to pay the greater of $2,000 or actual costs, for other general and
administrative expenses incurred by TheraCour on our behalf (4) to make royalty
payments of 15% (calculated as a percentage of net sales of the licensed
drugs)
to TheraCour; (5) that TheraCour Pharma, Inc. shall retain the exclusive
right
to develop and synthesize nanomicelle(s), a small (approximately twenty
nanometers in size) long chain polymer based chemical structure, as component
elements of the Licensed Products. TheraCour agreed that it will develop
and
synthesize such nanomicelle exclusively for NanoViricides, and unless such
license is terminated, will not develop or synthesize such nanomicelle for
its
own sake or for others; and (6) to pay an advance payment equal to twice
the
amount of the previous months invoice to be applied as a prepayment towards
expenses.
Development
costs charged by and paid to TheraCour Pharma, Inc. was $877,777 since inception
through September 30, 2006; $184,885 and $125,088 for the three months ended
September 30, 2006 and 2005, respectively; and $692,892 and $30,771 for the
years ended June 30, 2006 and 2005, respectively. No royalties are due or
have
been paid from inception through September 30, 2006.
TheraCour
may
terminate the License upon a material breach by us as specified in the
agreement. However, the Company has the opportunity to cure the breach within
90
days of receipt of notice to terminate the License.
As
of
December 31, 2006, TheraCour owns 35,370,000 shares of the Company’s outstanding
common stock.
Anil
Diwan, the Company’s President and Chairman, also serves as the CEO and Director
of TheraCour and owns approximately 65% of the outstanding capital stock
of
TheraCour. Leo Ehrlich, the Company’s Chief Financial Officer, serves as
TheraCour’s Director and owns approximately 10% of the outstanding capital stock
of TheraCour.
KARD
Scientific, Inc.
In
June
2005, the Company engaged KARD Scientific to conduct pre clinical
human
influenza animal (mouse) studies
and
provide the Company with a full history of the study and final report with
the
data collected. This project is on-going. NanoViricides has a fee for service
arrangement with KARD. We do not have an exclusive arrangement with KARD;
we do
not have a contract with Kard; and all work performed by Kard must have prior
approval of the executive officers of NanoViricides. Dr. Krishna Menon, the
Company’s Chief Regulatory Officer, a non-executive officer position, is also an
officer and principal owner of KARD Scientific. Lab fees charged by KARD
Scientific for services for the years ended June 30, 2006 and 2005, were
$206,499 and $0 respectively. For the three months ended September 30, 2006,
we
did not incur any charges by KARD. The Company has paid KARD a $50,000 advance
payment towards future fees.
ITEM
8: DESCRIPTION OF SECURITIES
COMMON
STOCK
Number
of Authorized and Outstanding Shares
.
The
Company's Articles of Incorporation authorizes the issuance of 300,000,000
shares of Common Stock, $.001 par value per share, of which 112,417,502 shares
were outstanding on December 31, 2006.
Voting
Rights
.
Holders
of shares of Common Stock are entitled to one vote for each share on all
matters
to be voted on by the stockholders. Holders of Common Stock have no cumulative
voting rights. Accordingly, the holders of in excess of 50% of the aggregate
number of shares of Common Stock outstanding will be able to elect all of
the
directors of the Company and to approve or disapprove any other matter submitted
to a vote of all stockholders.
Other
.
No
shareholder has any preemptive right or other similar right to purchase or
subscribe for any additional securities issued by the Company, and no
shareholder has any right to convert the common stock into other securities.
No
shares of common stock are subject to redemption or any sinking fund provisions.
All the outstanding shares of the Company's common stock are fully paid and
non-assessable. Subject to the rights of the holders of the preferred stock,
if
any, the Company's shareholders of common stock are entitled to dividends
when,
as and if declared by the Board from funds legally available therefore and,
upon
liquidation, to a pro-rata share in any distribution to shareholders. The
Company does not anticipate declaring or paying any cash dividends on the
common
stock in the foreseeable future.
Preferred
Stock
The
Company's Articles of Incorporation does not provide for the issuance of
Preferred Stock.
Common
Stock Purchase Warrants
As
of
September 30, 2006, there were 3,445,000 Common Stock Purchase Warrants
outstanding. Each warrant is exercisable to purchase one share of the Company’s
common stock under the following terms:
|
Ÿ
|
200,000
warrants exercisable at $0.25 per share, and expire on July 31,
2006.
These warrants were issued in connection with the $100,000 Series
A
Convertible Debenture Financing and were exercised in July 2006
and
resulted in proceeds to the Company of $50,000 and the issuance
of 200,000
common shares.
|
|
Ÿ
|
1,370,000
warrants exercisable at $1.00 per share, and expire on December
31, 2008.
These warrants were issued in connection with the $1,370,000 Stock
Subscription Offering closed in December
2005.
|
|
Ÿ
|
1,875,000
warrants exercisable at $2.50 per share, and expire on June 15,
2009.
These warrants were issued in connection with the $1,875,000 Stock
Subscription Offering closed in June
2006.
|
|
Ÿ
|
40,000
warrants exercisable at $0.18 per share, and expire on August 15,
2009.
These warrants were issued as compensation to our Scientific Advisory
Board.
|
|
Ÿ
|
40,000
warrants exercisable at $1.14 per share, and expire on November
15, 2009.
These warrants issued as compensation to our Scientific Advisory
Board.
|
|
Ÿ
|
40,000
warrants exercisable at $2.18 per share, and expire on February
15, 2010.
These warrants were issued as compensation to our Scientific Advisory
Board.
|
|
Ÿ
|
40,000
warrants exercisable at $2.20 per share, and expire on May 15,
2010. These
warrants were issued as compensation to our Scientific Advisory
Board.
|
|
Ÿ
|
40,000
warrants exercisable at $1.36 per share, and expire on August 15,
2010.
These warrants were issued as compensation to our Scientific Advisory
Board.
|
Stock
Options
As
of
September 30, 2006, the Company had outstanding an aggregate of 2,000,000
stock
options held by the Company’s officers. Each option is exercisable to purchase
one share of the Company’s Common Stock at $.10 per share. 833,333 of the
options are presently exercisable and 1,166,667 options, vest upon the holder
meeting certain employment conditions. The options expire September 26,
2015.
Convertible
Debentures
As
of
September 30, 2006, the Company has no outstanding debentures.
As
of
June 30, 2006, the Company had sold an aggregate of $1,000,000 of 9% Series
A
convertible debentures maturing July 31, 2006. The debentures accrued interest
at the rate of 9%, interest payable quarterly in an amount of shares of Common
Stock equal to the average closing price for the preceding fifteen trading
days
prior to the close of the respective quarterly period. The principal balance
of
the Debentures may be repaid, at the debenture holders' option in cash, or,
with
a number of shares of common stock equal to the lower of seventy percent
of the
average closing price of the fifteen trading days prior to maturity or $.30
per
share.
In
July
2006, all outstanding debentures were converted by the debenture holders
into
3,333,333 shares of the Company’s common stock.
Transfer
Agent
Shares
of
Common Stock are registered at the transfer agent and are transferable at
such
office by the registered holder (or duly authorized attorney) upon surrender
of
the Common Stock certificate, properly endorsed. No transfer shall be registered
unless the Company is satisfied that such transfer will not result in a
violation of any applicable federal or state securities laws. The Company's
transfer agent for its Common Stock is Empire Stock Transfer, Inc.,
2470
Saint Rose Pkwy, Suite 304 Henderson, NV 89074, telephone (702)
818-5898.
Penny
Stock
The
Commission has adopted rules that define a “penny stock” as equity securities
under $5.00 per share which are not listed for trading on Nasdaq (unless
the
issuer (i) has a net worth of $2,000,000 if in business for more than three
years or $5,000,000 if in business for less than three years or (ii) has
had
average annual revenue of $6,000,000 for the prior three years). The Company’s
securities are characterized as penny stock, and therefore broker-dealers
dealings in the securities are subject to the disclosure rules of transactions
involving penny stock which require the broker-dealer, among other things,
to
(i) determine the suitability of purchasers of the securities and obtain
the
written consent of purchasers to purchase such securities and (ii) disclose
the
best (inside) bid and offer prices for such securities and the price at which
the broker-dealer last purchased or sold the securities. The additional
requirements imposed upon broker-dealers discourage them from e
ngaging
in transactions in penny stocks, which reduces the liquidity of the Company’s
securities.
Provisions
Having A Possible Anti-Takeover Effect
We
are
subject to the State of Nevada's business combination statute. In general,
the
statute prohibits a publicly held Nevada corporation from engaging in a business
combination with a person who is an interested shareholder for a period of
three
years after the date of the transaction in which that person became an
interested shareholder, unless the business combination is approved in a
prescribed manner. A business combination includes a merger, asset sale or
other
transaction resulting in a financial benefit to the interested shareholder.
An
interested shareholder is a person who, together with affiliates, owns, or,
within three years prior to the proposed business combination, did own 15%
or
more of our voting stock. The statute could prohibit or delay mergers or
other
takeovers or change in control attempts and accordingly, may discourage attempts
to acquire our Company.
PART
II
Item
1. Market Price of and Dividends on the Registrant's Common
Equity and Other Shareholder Matters
Market
for Common Equity and Related Stockholder Matters
The
Company’s Common Stock currently trades on the Pink Sheets under the symbol
NNVC. The table below sets forth the high and low prices for the Company’s
Common Stock for the quarters included within 2005 and 2006. Quotations reflect
inter-dealer prices, without retail mark-up, mark-down commission, and may
not
represent actual transactions. Since the Company's common stock trades
sporadically, there is not an established active public market for its common
stock. No assurance can be given that an active market will exist for the
Company's common stock and the Company does not expect to declare dividends
in
the foreseeable future since the Company intends to utilize its earnings,
if
any, to finance its future growth, including possible acquisitions.
Quarter
ended
|
|
Low
price
|
|
High
price
|
|
|
|
|
|
|
|
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
The
Company is filing this Registration Statement on Form 10-SB for the purpose
of
enabling its common stock to commence trading on the NASD OTC Bulletin Board.
The Company's Registration Statement on Form 10 must be declared effective
by
the SEC prior to it being approved for trading on the NASD OTC Bulletin Board,
and until such time as this Form 10- SB is declared effective, the Company's
common stock will continue to be quoted on the "Pink Sheets." The Company's
market makers must make an application to the National Association of Securities
Dealers, Inc., or NASD, following the effective date of this Form 10-SB in
order
to have the common stock quoted on the NASD OTC Bulletin Board.
Number
of Shareholders
.
As
of
September 30, 2006, a total of 112,417,502 the Company’s common stock (shares)
are outstanding and held by approximately 110 shareholders of record. Of
this
amount, 22,105,732 shares are unrestricted. Approximately 23,666,770 shares
are
restricted securities held by non-affiliates, and the remaining 66,645,000
shares are restricted securities held by affiliates. These shares may only
be
sold in accordance with Rule 144. As of September 30, 2006, there were
3,445,000
warrants
and 2,000,000 stock options to purchase the Company’s Common Stock outstanding.
Dividends
.
The
Company has not paid any dividends since its inception. The Company currently
intends to retain any earnings for use in its business, and therefore does
not
anticipate paying dividends in the foreseeable future.
LONG-TERM
INCENTIVE PLANS AWARDS IN LAST FISCAL YEAR
None
Item
2. Legal Proceedings.
There
are
no other legal proceedings against the Company to the best of the Company’s
knowledge as of the date hereof and to the Company’s knowledge, no action, suit
or proceeding has been threatened against the Company.
Item
3. Changes in and Disagreements with
Accountants.
On
May
11, 2006, our Board of Directors voted to replace Bloom & Co., LLP ("Bloom")
as its independent registered public accounting firm, and to retain Holtz
Rubenstein Reminick LLP as our principal public accounting firm. On June
2,
2006, we notified Bloom. While Bloom did not complete its audit of the Company,
nor issue any reports to the Company, there were no disagreements with Bloom
on
any matter of accounting principles or practices, financial statement
disclosure, or auditing scope or procedure.
Prior
to
retaining Holtz Rubenstein Reminick LLP, management did not consult Holtz
Rubenstein Reminick LLP regarding the application of accounting principles
to a
specific completed or contemplated transaction or the type of audit opinion
that
might be rendered, nor concerning any matter that was the subject of any
disagreement or event.
Item
4.
Recent sales of Unregistered
Securities.
Set
forth
below is information regarding common stock issued, warrants issued and stock
options granted by the Company within the past three (3) years. Also included
is
the consideration, if any, received and information related to the provision
of
the Securities Act under which an exemption from registration was
claimed
:
|
1.
|
On
May 12, 2005, prior to the Company’s reverse acquisition by NanoViricide,
Inc., the Company issued 13,750,000 shares of common stock in connection
with a forward split of the Company’s common stock on a 3.2 for 1
basis.
|
|
2.
|
On
June 1, 2005, in connection with the Company’s reverse acquisition by
NanoViricide, Inc., the Company issued 80,000,000 shares of common
stock
to the shareholders of NanoViricide,
Inc.
|
|
3.
|
On
June 1, 2005, Allan Marshall and Robert Weidenbaum, stockholders
who were
instrumental in the negotiation, execution, and consummation of
the
acquisition by Edotcom.com of Nanoviricide, Inc., each received
options to
purchase 1,000,000 shares of NVI Common Stock at a price of $.05
per
share, expiring May 31, 2008. The fair value of these options in
the
amount of $107,028 was charged to additional paid in capital. In
May 2006,
options were converted into 1,800,000 shares of common stock resulting
in
proceeds to the Company of $90,000. The remaining 200,000 options
were
cancelled pursuant to an agreement between the parties. The fair
value of
cancelled options of $10,703 was reversed against additional paid
in
capital.
|
|
4.
|
On
June 1, 2005, MJT Consulting, Inc., another party that was instrumental
in
the negotiation, execution, and consummation of the acquisition
by ECMM of
NVI, was granted an option to purchase 1,000,000 shares of NVI
Common
Stock at a price of $2.50 per share, expiring in May 2006. The
fair value
of these options was immaterial. These options were not converted
and have
expired.
|
|
5.
|
On
May 13, 2005, the Company's Board of Directors established a Scientific
Advisory Board. As compensation, each member of the Scientific
Advisory
Board (SAB) is to be granted quarterly 10,000 warrants to purchase
the
Company’s common stock at 120% of the Company’s closing stock price on the
day following the meeting. Through September 30, 2006, the SAB
was granted
a total of 200,000 stock warrants exercisable into common shares
at prices
from $0.18 to $2.20 per share. These warrants, if not exercised
will
expire on various dates through August 2010.
The
fair value of these warrants in the amount of $160,268 was recorded
as
consulting expense.
|
|
6.
|
On
September 23, 2005, the Company issued 2,200,000 shares of Common
Stock to
Jayant Tatake (200,000 shares) and Ann Onton (2,000,000 shares)
for
scientific consulting compensation for development work on the
Company’s
anti viral compounds. Based upon the fair market value of the common
stock
on the commitment date, the Company recorded a consulting expense
of
$178,200.
|
|
7.
|
On
September 23, 2005, the Company issued 100,000 shares of Common
Stock to
David F. Gencarelli, an outside consultant, for advising the Company
on
government procurements. Based upon the fair market value of the
common
stock on the commitment date, the Company recorded a consulting
expense of
$8,100.
|
|
8.
|
On
September 30, 2005, the Company issued 48,177 shares of Common
Stock to
the Series A Debenture Holders in lieu of interest on the Series
A
Debentures. The Company recorded an interest expense of
$4,315.
|
|
9.
|
From
November 28, 2005 through December 30, 2005, the Company closed
a private
equity financing for net proceeds of $1,370,000. The Company sold
2,740,000 shares of common stock at $.50 per share. These investors
also
received warrants for the purchase of 1,370,000 common shares at
$1.00 per
share. These warrants expire on various dates through December
2008.
The Company allocated a relative fair value of $483,610 to these
$1.00
warrants by using the Black-Scholes option pricing
model.
|
|
10.
|
On
December 06, 2005, the Company issued 20,000 shares of Common Stock,
to
Joseph Sansone, an outside consultant advising the Company on government
procurements. Based upon the fair market value of the common stock
on the
commitment date, the Company recorded a consulting expense of $19,000.
|
|
11.
|
On
December 15, 2005, the Company issued 50,000 shares of Common Stock,
to
Paul Taublieb for consulting services rendered. Based upon the
fair market
value of the common stock on the commitment date, the Company recorded
a
deferred financing cost of $49,000, which is being amortized using
the
straight-line method over the term of the debenture.
|
|
12.
|
On
December 31, 2005, the Company granted 19,476 shares of its common
stock
with a restrictive legend, to the debenture holders in lieu of
interest on
debentures. The Company recorded an interest expense of
$17,340.
|
|
13.
|
On
January 9, 2006, the Company issued 3,425 shares of Common Stock
to an
outside consultant for services. Based upon the fair market value
of the
common stock on the commitment date, the Company recorded a consulting
expense of $5,001.
|
|
14.
|
On
March 31, 2006, the Company granted 7,921 shares of its common
stock with
a restrictive legend, to the debenture holders in lieu of interest
on
debentures. The Company recorded an interest expense of
$22,192
|
|
15.
|
On
June 15, 2006, the Company closed a private equity financing for
net
proceeds of $1,875,000 with several accredited investors pursuant
to
Regulation D of the Securities Act. The Company sold 1,875,000
shares of
common stock at $1.00 per share. These investors also received
warrants
for the purchase of 1,875,000 common shares at $2.50 per share.
These
warrants expire in June 2009.
The
Company allocated a relative fair value of $779,022 of these warrants
by
using the Black-Scholes option pricing
model.
|
|
16.
|
From
July 13, 2005 through November 19, 2005, the Company issued $1,000,000
of
9% Series A Convertible Debentures and 200,000 warrants to purchase
the
Company’s Common Stock, exercisable at a price per common share of $.25.
Interest on these debentures were payable quarterly in common stock
and
resulted in the issuance of 90,000 shares of common stock. The
warrants on
these debentures were exercised in July 2006 and resulted in proceeds
to
the Company of $50,000 and the issuance of 200,000 common shares.
In July
2006, the convertible debentures were all converted into common
stock,
resulting in the issuance of 3,333,333 common
shares.
|
|
17.
|
On
September 26, 2005,
500,000
stock options were granted to Eugene Seymour, our CEO under an
employment
agreement. The options expire in September 2015.
Based on fair market value of these options, $25,579 was recognized
as
stock based compensation expense from inception through September
30,
2006, and $6,172
will
be recorded over the remaining vested
period.
|
|
18.
|
On
September 26, 2005, 1,000,000 stock options were granted to Anil
Diwan,
our Chairman and President under an employment agreement. The options
expire in September 2015.
Based
on fair market value of these options, $47,860 was recognized as
stock
based compensation expense from inception through September 30,
2006, and
$16,179 will be recorded over the remaining vesting
period.
|
|
19.
|
On
September 26, 2005, 500,000 stock options were granted to Leo Ehrlich,
our
CFO under an employment agreement. The options expire in September
2015.
Based on fair market value of these options, $25,579 was recognized
as
stock based compensation expense from inception through September
30,
2006, and $6,172 will be recorded over the remaining vesting
period.
|
|
20.
|
On
June 30, 2006, the Company granted 14,426 shares of its common
stock with
a restrictive legend, to the debenture holders in lieu of interest
on
debentures.
The
Company recorded an interest expense of
$22,438.
|
All
of
the securities set forth above were issued by the Company pursuant to Section
4(2) of the Securities Act of 1933, as amended, or the provisions of Rule
504 of
Regulation D promulgated under the Securities Act. All such shares issued
contained a restrictive legend and the holders confirmed that they were
acquiring the shares for investment and without intent to distribute the
shares.
All of the purchasers were friends or business associates of the Company’s
management and all were experienced in making speculative investments,
understood the risks associated with investments, and could afford a loss
of the
entire investment. The Company has never utilized an underwriter for an offering
of its securities.
Item
5.
Indemnification of Directors and
Officers.
Neither
our Articles of Incorporation nor Bylaws prevent us from indemnifying our
officers, directors and agents to the extent permitted under the Nevada Revised
Statute ("NRS"). NRS Section 78.7502, provides that a corporation shall
indemnify any director, officer, employee or agent of a corporation against
expenses, including attorneys’ fees, actually and reasonably incurred by him in
connection with any the defense to the extent that a director, officer, employee
or agent of a corporation has been successful on the merits or otherwise
in
defense of any action, suit or proceeding referred to Section 78.7502(1)
or
78.7502(2), or in defense of any claim, issue or matter therein. NRS 78.7502(1)
provides that a corporation may indemnify any person who was or is a party
or is
threatened to be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative,
except an action by or in the right of the corporation, by reason of the
fact
that he is or was a director, officer, employee or agent of the corporation,
or
is or was serving at the request of the corporation as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust
or
other enterprise, against expenses, including attorneys’ fees, judgments, fines
and amounts paid in settlement actually and reasonably incurred by him in
connection with the action, suit or proceeding if he: (a) is not liable pursuant
to NRS 78.138; or (b) acted in good faith and in a manner which he reasonably
believed to be in or not opposed to the best interests of the corporation,
and,
with respect to any criminal action or proceeding, had no reasonable cause
to
believe his conduct was unlawful.
NRS
Section 78.7502(2) provides that a corporation may indemnify any person who
was
or is a party or is threatened to be made a party to any threatened, pending
or
completed action or suit by or in the right of the corporation to procure
a
judgment in its favor by reason of the fact that he is or was a director,
officer, employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise against
expenses, including amounts paid in settlement and attorneys’ fees actually and
reasonably incurred by him in connection with the defense or settlement of
the
action or suit if he: (a) is not liable pursuant to NRS 78.138; or (b) acted
in
good faith and in a manner which he reasonably believed to be in or not opposed
to the best interests of the corporation.
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
Index
to Financial Statements
Financial
Statements For June 30, 2006
|
|
|
|
|
67
|
|
|
Financial
Statements
|
|
|
|
|
|
|
68
|
|
|
|
|
|
69
|
|
|
|
|
|
70
|
|
|
|
|
|
73
|
|
|
|
|
75
|
|
|
Financial
Statements For September 30, 2006
|
|
|
|
|
87
|
|
|
|
88
|
|
|
|
89
|
|
|
|
92
|
|
|
|
94
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the
Board of Directors and
Shareholders
of NanoViricides, Inc.
We
have
audited the accompanying balance sheets of NanoViricides, Inc. (a development
stage company) as of June 30, 2006 and 2005, and the related statements of
operations, shareholders’ equity (deficit) and cash flows for the year ended
June 30, 2006, the period from May 12, 2005 (date of inception) through June
30,
2005 and the cumulative period from May 12, 2005 (date of inception) through
June 30, 2006. These financial statements are the responsibility of the
company’s management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit also includes examining,
on a test basis, evidence supporting the amounts and disclosures in the
financial statements, assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In
our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of NanoViricides, Inc. as of June
30,
2006 and 2005, and the results of its operations and its cash flows for the
year
ended June 30, 2006, the period from May 12, 2005 (date of inception) through
June 30, 2005 and the cumulative period from May 12, 2005(date of inception)
through June 30, 2006 in conformity with accounting principles generally
accepted in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 2 to the financial
statements, the Company has no viable operations, has suffered significant
operating losses and is dependent upon its stockholders to provide sufficient
working capital to meet its obligations and sustain its operations. These
circumstances raise substantial doubt about the Company’s ability to continue as
a going concern. Management’s plans regarding those matters are also described
in Note 2. The accompanying financial statements do not contain any adjustments
that might result from the outcome of these uncertainties.
|
/s/
Holtz Rubenstein Reminick LLP
|
|
|
|
New
York, New York
|
October
10, 2006
|
|
(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEETS
|
|
June
30, 2006
|
|
June
30, 2005
|
|
|
|
(RESTATED)
|
|
(RESTATED)
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
2,507,102
|
|
$
|
-
|
|
Prepaid
expenses
|
|
|
213,728
|
|
|
-
|
|
Total
current assets
|
|
|
2,720,830
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
2,054
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Deferred
expenses, net
|
|
|
6,714
|
|
|
-
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$
|
2,729,598
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Accounts
payable - trade
|
|
$
|
$44,076
|
|
$
|
10,174
|
|
Accounts
payable - related parties
|
|
|
203,045
|
|
|
38,307
|
|
Accrued
expenses
|
|
|
90,831
|
|
|
17,524
|
|
Accrued
payroll to officers and related payroll tax expense
|
|
|
232,282
|
|
|
-
|
|
Other
payroll taxes payable
|
|
|
3,826
|
|
|
-
|
|
TOTAL
CURRENT LIABILITIES
|
|
|
574,060
|
|
|
66,005
|
|
|
|
|
|
|
|
|
|
LONG
TERM DEBT:
|
|
|
|
|
|
|
|
Debentures,
net
|
|
|
917,082
|
|
|
-
|
|
TOTAL
LIABILITIES
|
|
|
1,491,142
|
|
|
66,005
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’
EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value; 300,000,000 shares authorized at June
30, 2006
and 2005
;
issued and outstanding: 108,878,425 (2006) and 100,000,000
(2005)
|
|
|
108,878
|
|
|
100,000
|
|
Additional
paid-in capital
|
|
|
4,480,035
|
|
|
(99,980
|
)
|
Stock
subscription receivable
|
|
|
(20
|
)
|
|
(20
|
)
|
Deficit
accumulated during the development stage
|
|
|
(3,350,437
|
)
|
|
(66,005
|
)
|
TOTAL
SHAREHOLDERS’ EQUITY (DEFICIT)
|
|
|
1,238,456
|
|
|
(66,005
|
)
|
TOTAL
LIABILITIES AND
SHAREHOLDERS’
EQUITY (DEFICIT)
|
|
$
|
2,729,598
|
|
$
|
-
|
|
The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF OPERATIONS
|
|
Year
Ended
June
30. 2006
|
|
For
the Period From
May
12, 2005
(Inception)
through
June
30,
2005
|
|
For
the Cumulative Period
From
May 12, 2005
(Inception)
through
June
30, 2006
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
899,891
|
|
|
30,771
|
|
|
930,662
|
|
General
and administrative (of this amount $427,703, $0, and $427,703 was
for
stock and option based compensation to consultants and officers
for each
period presented)
|
|
|
1,695,957
|
|
|
35,234
|
|
|
1,731,191
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
2,595,848
|
|
|
66,005
|
|
|
2,661,853
|
|
Loss
from operations
|
|
|
(2,595,848
|
)
|
|
(66,005
|
)
|
|
(2,661,853
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expenses):
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
7,863
|
|
|
-
|
|
|
7,863
|
|
Non
cash interest on convertible debentures
|
|
|
(66,286
|
)
|
|
-
|
|
|
(66,286
|
)
|
Non
cash interest expense on beneficial conversion feature of convertible
debentures
|
|
|
(630,161
|
)
|
|
-
|
|
|
(630,161
|
)
|
Total
other expenses
|
|
|
(688,584
|
)
|
|
-
|
|
|
(688,584
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(3,284,432
|
)
|
$
|
(66,005
|
)
|
$
|
(3,350,437
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share: basic and diluted
|
|
$
|
(0.03
|
)
|
$
|
(0.00
|
)
|
$
|
(0.03
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding: basic and diluted
|
|
|
103,591,691
|
|
|
100,000,000
|
|
|
103,327,328
|
|
The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIT)
FOR
THE CUMULATIVE PERIOD MAY 12, 2005 (INCEPTION) THROUGH JUNE 30, 2006
(RESTATED)
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
Number
of
Shares
|
|
Par
Value
$.001
|
|
Additional
Paid-in
Capital
|
|
Stock
Subscription
Receivable
|
|
Accumulated
Deficit
|
|
Total
Shareholders'
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
|
)
|
|
-
|
|
|
-
|
|
|
-
|
|
Options
granted in connection with reverse acquisition
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Net
loss period ended June 30, 2005
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(66,005
|
)
|
|
(66,005
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at June 30, 2005 (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
|
|
Options
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
|
|
The
accompanying notes are an integral part of these financial
statements.
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
Number
of
Shares
|
|
Par
Value
$.001
|
|
Additional
Paid-in
Capital
|
|
Stock
Subscription
Receivable
|
|
Accumulated
Deficit
|
|
Total
Shareholders'
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
|
|
Options
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
|
|
The
accompanying notes are an integral part of these financial
statements.
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
Number
Of
Shares
|
|
Par
Value
$.001
|
|
Additional
Paid-in
Capital
|
|
Stock
Subscription
Receivable
|
|
Accumulated
Deficit
|
|
Total
Shareholders'
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
|
|
Options
issued to Scientific Advisory Board on February 15, 2006
|
|
|
-
|
|
|
-
|
|
|
49,067
|
|
|
-
|
|
|
-
|
|
|
49,067
|
|
Options
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 (Restated)
|
|
|
108,878,425
|
|
$
|
108,878
|
|
$
|
4,480,035
|
|
$
|
(20
|
)
|
$
|
(3,350,437
|
)
|
$
|
1,238,456
|
|
The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS
|
|
Year
Ended
June
30. 2006
|
|
For
the Period From
May
12, 2005
(Inception)
through
June
30,
2005
|
|
For
the Cumulative
Period
From
May 12, 2005
(Inception)
through
June
30, 2006
|
|
|
|
|
|
|
|
|
|
OPERATING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(3,284,432
|
)
|
$
|
(66,005
|
)
|
$
|
(3,350,437
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
Shares
issued for services rendered
|
|
|
210,301
|
|
|
-
|
|
|
210,301
|
|
Warrants
granted to scientific advisory board
|
|
|
130,084
|
|
|
-
|
|
|
130,084
|
|
Options
issued to officers as compensation
|
|
|
87,318
|
|
|
-
|
|
|
87,318
|
|
Depreciation
|
|
|
94
|
|
|
-
|
|
|
94
|
|
Amortization
of deferred financing expenses
|
|
|
44,461
|
|
|
-
|
|
|
44,461
|
|
Non
cash interest on convertible debentures
|
|
|
66,286
|
|
|
-
|
|
|
66,286
|
|
Non
cash interest expense on beneficial conversion feature of convertible
debentures
|
|
|
630,161
|
|
|
-
|
|
|
630,161
|
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(213,728
|
)
|
|
-
|
|
|
(213,728
|
)
|
Deferred
expenses
|
|
|
(2,175
|
)
|
|
-
|
|
|
(2,175
|
)
|
Accounts
payable- trade
|
|
|
33,902
|
|
|
10,174
|
|
|
44,076
|
|
Accounts
payable -related parties
|
|
|
164,738
|
|
|
38,307
|
|
|
203,045
|
|
Accrued
expenses
|
|
|
73,307
|
|
|
17,524
|
|
|
90,831
|
|
Accrued
payroll to officers and related payroll tax expense
|
|
|
232,282
|
|
|
-
|
|
|
232,282
|
|
Other
payroll taxes payable
|
|
|
3,826
|
|
|
-
|
|
|
3,826
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(1,823,575
|
)
|
|
-
|
|
|
(1,823,575
|
)
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Purchases
of property and equipment
|
|
|
(2,148
|
)
|
|
-
|
|
|
(2,148
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(2,148
|
)
|
|
-
|
|
|
(2,148
|
)
|
|
|
|
|
|
|
|
|
|
|
|
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 exercise of stock options
|
|
|
90,000
|
|
|
-
|
|
|
90,000
|
|
Payment
of legal expenses related to private placement
|
|
|
(2,175
|
)
|
|
-
|
|
|
(2,175
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
4,332,825
|
|
|
-
|
|
|
4,332,825
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
2,507,102
|
|
|
-
|
|
|
2,507,102
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, BEGINNING
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, ENDING
|
|
$
|
2,507,102
|
|
$
|
-
|
|
$
|
2,507,102
|
|
The
accompanying notes are an integral part of these financial
statements.
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS (CONTINUED)
SUPPLEMENTAL
DISCLOSURE OF NON-CASH ACTIVITY
During
the year ended June 30, 2006, the Company had the following non cash activity:
2,200,000
shares of common stock issued for services rendered.
|
|
$
|
178,200
|
|
|
|
|
|
|
100,000
shares of common stock issued for legal services rendered.
|
|
|
8,100
|
|
|
|
|
|
|
2,000,000
stock options issued to the officers as compensation
|
|
|
87,318
|
|
|
|
|
|
|
20,000
shares of common stock issued for services rendered
|
|
|
19,000
|
|
|
|
|
|
|
50,000
shares of common stock issued in connection with debenture
offering
|
|
|
49,000
|
|
|
|
|
|
|
3,425
shares of common stock issued for services rendered
|
|
|
5,001
|
|
|
|
|
|
|
90,000
shares issued for interest on debentures
|
|
|
66,286
|
|
|
|
|
|
|
160,000
stock warrants granted to scientific advisory board
|
|
|
130,084
|
|
|
|
|
|
|
3,245,000
warrants issued in connection with private placements
|
|
|
1,262,632
|
|
|
|
|
|
|
Debt
discount related to beneficial conversion feature of convertible
debt
|
|
|
713,079
|
|
The
accompanying notes are an integral part of these financial
statements
.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
JUNE
30, 2006 AND 2005
Note
1. Organization and Nature of Business
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25,
2000
as Edot-com.com, Inc
.
and
was
organized for the purpose of conducting internet retail sales. On April 1,
2005,
Edot-com.com, Inc
.
was
incorporated under the laws of the State of Nevada for the purpose of
re-domiciling the Company as a Nevada corporation. On May 12, 2005, the
Corporations were merged and Edot-com.com, Inc
.,
a
Nevada
corporation, (the Company), became the surviving entity.
On
June
1, 2005, Edot-com.com, Inc. (“ECMM”) acquired Nanoviricide, Inc., a privately
owned Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share
Exchange (the “Exchange”). Nanoviricide, Inc. was incorporated under the laws of
the State of Florida on May 12, 2005.
Pursuant
to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate
of
80,000,000 newly issued shares of ECMM common stock resulting in an aggregate
of
100,000,000 shares of ECMM common stock issued and outstanding. NVI then
became
a wholly-owned subsidiary of ECMM. The ECMM shares were issued to the NVI
Shareholders on a pro rata basis, on the basis of 4,000 shares of the Company’s
Common Stock for each share of NVI common stock held by such NVI Shareholder
at
the time of the Exchange.
As
a
result of the Exchange Transaction the former NVI stockholders held
approximately 80% of the voting capital stock of the Company immediately
after
the Exchange Transaction. For financial accounting purposes, this acquisition
was a reverse acquisition of the Company by NVI, under the purchase method
of
accounting, and was treated as a recapitalization with NVI as the acquirer.
Accordingly, the financial statements have been prepared to give retroactive
effect to May 12, 2005 (date of inception), of the reverse acquisition completed
on June 01, 2005, and represent the operations of NVI.
On
June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, Edot-com.com, Inc. changed
its name to NanoViricides, Inc. and its stock symbol to “NNVC”, respectively.
The Company is considered a development stage company at this time.
NanoViricides,
Inc. (the “Company”), is a nano-biopharmaceutical company whose business goals
are to discover, develop and commercialize therapeutics to advance the care
of
patients suffering from life-threatening viral infections. We are a development
stage company with several drugs in various stages of early development.
Our
drugs are based on several patents, patent applications, provisional patent
applications, and other proprietary intellectual property held by TheraCour
Pharma, Inc., to which we have the necessary licenses in perpetuity for the
treatment of the following human viral diseases: Human Immunodeficiency Virus
(HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex
Virus (HSV), Influenza and Asian Bird Flu Virus. We focus our research and
clinical programs on specific anti-viral solutions. We are seeking to add
to our
existing portfolio of products through our internal discovery and clinical
development programs and through an in-licensing strategy.
To date,
the Company has not developed any commercial products.
Restatement
In
response to the SEC comment letter, dated December 11, 2006, regarding their
review of the 10-SB registration statement filed November 14, 2006, certain
reclassification adjustments were reflected on the Balance Sheets as of June
30,
2006 and 2005, and Statements of Changes in Shareholder’s Equity (Deficit) for
the cumulative period from May 12, 2005 (date of inception) through June
30,
2006. These reclassifications had no effect on net loss, loss per share,
total
assets, total liabilities, or total shareholder’s equity (deficit).
The
table
below details the items affected by the restatement.
|
|
June
30, 2006
|
|
June
30, 2005
|
|
|
|
As
Reported
|
|
As
Restated
|
|
As
Reported
|
|
As
Restated
|
|
Balance
Sheets:
|
|
|
|
|
|
|
|
|
|
Additional
paid in capital
|
|
$
|
4,620,238
|
|
$
|
4,480,035
|
|
$
|
-
|
|
$
|
(99,980
|
)
|
Deferred
compensation
|
|
|
(40,223
|
)
|
|
-
|
|
|
-
|
|
|
-
|
|
Deficit
accumulated during the development stage
|
|
|
(3,450,417
|
)
|
|
(3,350,437
|
)
|
|
(165,985
|
)
|
|
(66,005
|
)
|
Total
Shareholder’s Equity (Deficit)
|
|
|
1,238,456
|
|
|
1,238,456
|
|
|
(66,005
|
)
|
|
(66,005
|
)
|
The
restatements above were also reflected on Statements of Changes in Shareholder’s
Equity (Deficit).
Note
2 -
Substantial
Doubt Regarding Ability to Continue as a Going Concern
Since
May
2005, the Company has been engaged exclusively in research and development
activities focused on developing targeted nano viral drugs. The Company has
not
yet commenced any product commercialization. The Company has incurred
significant operating losses since its inception, resulting in an accumulated
deficit of $3,350,417 at June 30, 2006. Such losses are expected to continue
for
the foreseeable future and until such time, if ever, as the Company is able
to
attain sales levels sufficient to support its operations. There can be no
assurance that the Company will achieve or maintain profitability in the
future.
Despite the Company’s financings in 2006 and 2005 (See Notes 7 and 8) and a cash
balance of $2,507,102 at June 30, 2006, substantial additional financing
will be
required in future periods, as the Company believes it will require in excess
of
$5,000,000 to fund its operations during the next twelve months.
We
have
planned in-vivo and in-vitro studies during the first quarter of 2007.
Thereafter, we plan to release the data from these studies and seek
substantial
additional financing
to
meet
our planned cash requirements through private placements of our common stock
and/or incurring debt. No assurances can be given that financing will be
available or be sufficient to meet our capital needs. If we are unable to
obtain
financing to meet our working capital requirements, then we may be required
to
modify our operations, including curtailing our business significantly or
ceasing operations altogether.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern which contemplates the realization of assets
and the satisfaction of liabilities in the normal course of business.
Accordingly, they do not include any adjustments relating to the realization
of
the carrying value of assets or the amounts and classification of liabilities
that might be necessary should the company be unable to continue as a going
concern. The Company's significant operating losses and significant capital
requirements, however, raise substantial doubt about the Company's ability
to
continue as a going concern.
Note
3. Summary of Significant Accounting Policies
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.
|
Property
and 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
year ended June 30, 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).
|
The
fair
value of the Company’s option-based awards granted to executive officers for the
year ended June 30, 2006 were estimated using the Black-Scholes option-pricing
model with following assumptions.
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%
|
Computation
of expected volatility for the year ended June 30, 2006, is based on the
equity
volatilities of four comparable companies. The computation of expected life
is
as stated in employment contracts. The risk free interest rates used in the
valuations of the fair value are based on risk free bond rates of similar
time
periods as the expected life of the stock options. Because the Company has
no
historical forfeiture rates, the stock option expense is not adjusted by
an
estimate for forfeiture as required under FASB 123(R).
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 for
past
services or expensed over the service period for future
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.
|
Basis
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, 2006 and 2005 were 5,605,000 and
3,000,000
respectively.
|
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, 2006 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
|
The
FASB
has issued Interpretation No. 46 (FIN-46R) (Revised December 2003),
Consolidation
of Variable Interest Entities
.
FIN-46R
clarifies the application of Accounting Research Bulletin No. 51, “Consolidated
Financial Statements,” to certain entities in which equity investors do not have
the characteristics of a controlling financial interest or do not have
sufficient equity at risk for the entity to finance its activities without
additional subordinated financial support from other parties. It separates
entities into two groups: (1) those for which voting interests are used to
determine consolidation and (2) those for which variable interests are used
to
determine consolidation (the subject of FIN-46R). FIN-46R clarifies how to
identify a variable interest entity and how to determine when a business
enterprise should include the assets, liabilities, non-controlling interests,
and results of activities of a variable interest entity in its consolidated
financial statements.
FIN-46R
requires that a variable interest entity to be consolidated by its “Primary
Beneficiary.” The Primary Beneficiary is the entity, if any, that stands to
absorb a majority of the variable interest entity’s expected losses, or in the
event that no entity stands to absorb a majority of the expected losses,
then
the entity that stands to receive a majority of the variable interest entity’s
expected residual returns. If it is reasonably possible that an enterprise
will
consolidate or disclose information about a variable interest entity when
FIN-
46R becomes effective, the enterprise is required to disclose in all financial
statements initially issued after December 31, 2003, the nature, purpose,
size,
and activities of the variable interest entity and the enterprise’s maximum
exposure to loss as a result of its involvement with the variable interest
entity. At June 30, 2006, the Company evaluated its relationship with TheraCour
Pharma, Inc. for purposes of FIN-46R, and concluded that it is not a variable
interest entity that is subject to consolidation in the Company’s financial
statements
under
FIN-46R.
In
December 2004, the FASB issued Statement of Financial Accounting Standards
("SFAS") No. 123 (revised 2004), Share-Based Payment ("SFAS No. 123-R").
SFAS
No.123-R is a revision of SFAS No. 123, as amended, Accounting for Stock-Based
Compensation, and supersedes Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees. SFAS No.123-R eliminates the
alternative to use the intrinsic value method of accounting that was provided
in
SFAS No. 123, which generally resulted in no compensation expense recorded
in
the financial statements related to the issuance of equity awards to employees.
SFAS No. 123-R requires that the cost resulting from all share based payment
transactions be recognized in the financial statements. SFAS No. 123-R
establishes fair value as the measurement objective in accounting for
share-based payment arrangements and requires all companies to apply a
fair-value-based measurement method in accounting for generally all share-based
payment transactions with employees. The Company adopted this statement using
the modified prospective transition method for awards made to employee and
directors, which required the application of the accounting standard as of
May
12, 2005 (date of inception).
In
May
2005, the FASB issued Statement No. 154, "Accounting Changes and Error
Corrections", a replacement of Accounting Principles Board Opinion No. 20,
"Accounting Changes", and Statement No. 3, "Reporting Accounting Changes
in
Interim Financial Statements" ("SFAS 154"). SFAS 154 changes the requirements
for the accounting for, and reporting of, a change in accounting principle.
Previously, voluntary changes in accounting principles were generally required
to be recognized by way of a cumulative effect adjustment within net income
during the period of the change. SFAS 154 requires retrospective application
to
prior periods' financial statements, unless it is impracticable to determine
either the period of specific effects or the cumulative effect of the change.
SFAS 154 is effective for accounting changes made in fiscal years beginning
after December 15, 2005; however, the statement does not change the transition
provisions of any existing accounting pronouncements. The Company does not
believe adoption of SFAS 154 will have a material effect on its financial
position, cash flows or results of operations.
In
February 2006, the FASB issued Statement of Financial Accounting Standards
No.
155, "Accounting for Certain Hybrid Financial Instruments" ("SFAS 155"),
which
amends SFAS No. 133, "Accounting for Derivatives Instruments and Hedging
Activities" ("SFAS 133") and SFAS No. 140, "Accounting for Transfers and
Servicing of Financial Assets and Extinguishment of Liabilities" ("SFAS 140").
SFAS 155 amends SFAS 133 to narrow the scope exception for interest-only
and
principal-only strips on debt instruments to include only such strips
representing rights to receive a specified portion of the contractual interest
or principle cash flows. SFAS 155 also amends SFAS 140 to allow qualifying
special-purpose entities to hold a passive derivative financial instrument
pertaining to beneficial interests that itself is a derivative instruments.
The
Company is currently evaluating the impact this new Standard, but believes
that
it will not have a material impact on the Company's financial
position.
In
September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (“SFAS No.
157”). SFAS No.157 defines fair value, establishes a framework for measuring
fair value and expands disclosures about fair value measurements. SFAS No.
157
is effective for the Company beginning with fiscal year 2009. The Company
is in
the
process
of assessing the effect SFAS No. 157 may have on its financial
statements.
On
September 29, 2006, the FASB issued FASB Statement No. 158, "Employers'
Accounting for Defined Benefit Pension and Other Postretirement Plans --
An
Amendment of FASB Statements No. 87, 88, 106, and 132R" ("SFAS 158"). This
new
standard requires an employer to: (a) recognize in its statement of financial
position an asset for a plan's overfunded status or a liability for a plan's
underfunded status; (b) measure a plan's assets and its obligations that
determine its funded status as of the end of the employer's fiscal year (with
limited exceptions); and (c) recognize changes in the funded status of a
defined
benefit postretirement plan in the year in which the changes occur. Those
changes will be reported in comprehensive income. The requirement to recognize
the funded status of a benefit plan and the disclosure requirements are
effective for the Company's fiscal year ending June 30, 2007. The requirement
to
measure plan assets and benefit obligations as of the date of the employer's
fiscal year-end statement of financial position is effective for fiscal years
ending after December 15, 2008. The Company has determined that there is
no
effect the adoption of SFAS 158 will have on the Company’s financial position
and results of operations.
On
July
13, 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty
in
Income Taxes—an interpretation of FASB Statement No. 109. Interpretation 48
clarifies the accounting for uncertainty in income taxes recognized in an
entity’s financial statements in accordance with Statement 109 and prescribes a
recognition threshold and measurement attribute for financial statement
disclosure of tax positions taken or expected to be taken on a tax return.
Additionally, Interpretation 48 provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. Interpretation 48 is effective for fiscal years
beginning after December 15, 2006, with early adoption permitted. We are
currently evaluating whether the adoption of Interpretation 48 will have
a
material effect on our consolidated financial position, results of operations
or
cash flows.
Note
4. Significant Alliances and Related Parties
TheraCour
Pharma, Inc.
Pursuant
to a Material License Agreement we entered into with TheraCour Pharma, Inc.,
(TheraCour), effective as of May 12, 2005 and amended on January 8, 2007,
the
Company was granted an exclusive license in perpetuity for technologies
developed by TheraCour for the five virus types: HIV, HCV, Herpes, Asian
(bird)
flu and Influenza. In consideration for obtaining this exclusive license,
we
agreed: (1) that TheraCour can charge its costs (direct and indirect) plus
no
more than 30% of direct costs as a Development Fee and such development fees
shall be due and payable in periodic installments as billed. (2) we will
pay
$25,000 per month for usage of lab supplies and chemicals from existing stock
held by TheraCour, (3) we will pay $2,000 or actual costs, whichever is higher
for other general and administrative expenses incurred by TheraCour on our
behalf (4) make royalty payments (calculated as a percentage of net sales
of the
licensed drugs) of 15% to TheraCour Pharma, Inc. (5) agreed that TheraCour
Pharma, Inc. retains the exclusive right to develop and synthesize the
licensed drugs. TheraCour Pharma, Inc. agreed that it will manufacture the
licensed drugs exclusively for NanoViricides, and unless such license is
terminated, will not manufacture such product for its own sake or for others,
(6) TheraCour may request and NanoViricides, Inc. will pay an advance payment
equal to twice the amount of the previous months invoice to be applied as
a
prepayment towards expenses.
TheraCour
Pharma, Inc.,
may
terminate the license upon a material breach by us as specified in the
agreement. However, we may avoid such termination if within 90 days of receipt
of such termination notice we cure the breach.
Development
costs charged by and paid to TheraCour Pharma, Inc. was $692,892 and $30,771
for
the years ended June 30, 2006 and 2005, respectively. No royalties have been
paid through the year ended June 30, 2006.
TheraCour
Pharma, Inc., is affiliated with the Company through the common control of
it
and our Company by Anil Diwan, President, and Leo Ehrlich, CFO, who are
directors of each corporation, and own approximately75% of the capital stock
of
TheraCour Pharma, Inc., which itself owns approximately 31% of the capital
stock
of the Company.
TheraCour
Pharma, Inc. owns 35,370,000 share of the Company’s outstanding common stock as
of June 30, 2006.
KARD
Scientific, Inc.
In
June
2005, the Company engaged KARD Scientific to conduct pre clinical
human
influenza animal (mouse) studies
and
provide the Company with a full history of the study and final report with
the
data collected. This project is on-going. NanoViricides has a fee for service
arrangement with KARD. We do not have an exclusive arrangement with KARD;
we do
not have a contract with Kard; and all work performed by Kard must have prior
approval of the executive officers of NanoViricides. Dr. Krishna Menon, the
Company’s Chief Regulatory Officer, a non-executive officer position, is also an
officer and principal owner of KARD Scientific. Lab fees charged by KARD
Scientific for services for the years ended June 30, 2006 and 2005, were
$206,499 and $0 respectively. The Company has paid KARD a $50,000 advance
payment towards future fees.
Note
5. Prepaid Expenses
Prepaid
expenses at June 30 are summarized as follows:
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
TheraCour
Pharma, Inc.
|
|
$
|
163,728
|
|
$
|
-
|
|
Kard
Scientific, Inc.
|
|
|
50,000
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
$
|
213,728
|
|
$
|
-
|
|
(See
Note
4. Significant Alliances and Related Parties)
Note
6. Deferred Financing Expenses
Deferred
Financing Expenses represent the value of cash payments and common stock
issued
for attorney fees and to an investor as consideration for debt financing
during
the year. As of June 30, 2006, net deferred financing cost was $6,714, which
is
being amortized on a straight-line basis over the term of the debenture.
Amortization expense for the years ended 2006 and 2005 was $44,461 and $
0,
respectively.
Note
7. Convertible Notes Payable
In
July
2005 the Company’s board of directors authorized the issuance and sale of up to
one million dollars of convertible debentures. These debentures mature July
31,
2006 and carry an interest rate of 9% per year and are convertible into common
stock at the lower of 70% of the average closing price of the common stock
during the 15 days trading days preceding the Maturity Date or $.30 per share.
In accordance with EITF Issue 98-5 “Accounting for Convertible Securities with
Beneficial Conversion Features or Contingently Adjustable Conversion Ratios”, as
amended by EITF 00-27 “Application of Issue No. 98-5 to certain Convertible
Instruments”, the Company had evaluated that the convertible debt had a
beneficial conversion feature as the conversion price was less than the fair
value of the Company's common stock on the measurement date. Accordingly,
the
Company recognized this beneficial conversion feature by recording debt discount
and corresponding additional paid in capital, in the amount of $713,079.
The
debt discount is being amortized on a straight-line basis over the term of
these
debentures. Amortization expense for the years ended June 30, 2006 and 2005
was
$630,161 and $0, respectively.
As
of
June 30, 2006; the Company issued an aggregate of $1,000,000 in convertible
debentures.
In
July
2006, subsequent to the balance sheet date, the debentures holders converted
all
outstanding debentures. As a result of these conversions, the amounts to
be
converted ($1,000,000) which existed at June 30, 2006, have been reflected
as
long-term liabilities on the Company's June 30, 2006 balance sheet. Also,
as a
result of these conversions, the Company is obligated to issue an aggregate
total of 3,333,333 shares of the Company's $.001 par value common
stock.
For
the
year ended June 30, 2006, interest expense on the convertible notes in the
amount of $66,286, was paid with 90,000 shares of the Company’s common stock.
Note
8. Stock Transactions
Pursuant
to the terms of the reverse acquisition of Nanoviricide, Inc. an aggregate
of
100,000,000 shares of common stock were issued and outstanding as of June
1,
2005, the date of the reverse acquisition. Of this amount, 80,000,000
represented founders shares of Nanoviricide, Inc. and 20,000,000 represented
shares held by shareholders of Edotcom.com (see Note 1).
In
June
2005, Allan Marshall and Robert Weidenbaum, stockholders who were instrumental
in the negotiation, execution, and consummation of the acquisition by
Edotcom.com of Nanoviricide, Inc., each received options to purchase 1,000,000
shares of NVI Common Stock at a price of $.05 per share, expiring May 31,
2008.
The fair value of these options in the amount of $107,028 was charged to
additional paid in capital. In May 2006, options were converted into 1,800,000
shares of common stock resulting in proceeds to the Company of $90,000. The
remaining 200,000 options were cancelled pursuant to an agreement between
the
parties. The fair value of cancelled options of $10,703 was reversed against
additional paid in capital.
In
June
2005, MJT Consulting, Inc., another party that was instrumental in the
negotiation, execution, and consummation of the acquisition by ECMM of NVI,
was
granted an option to purchase 1,000,000 shares of NVI Common Stock at a price
of
$2.50 per share, expiring in May 2006. The fair value of these options was
immaterial. These options were not converted and have expired.
In
May
2005, the Company's Board of Directors established a Scientific Advisory
Board.
As compensation, each member of the Scientific Advisory Board (SAB) is to
be
granted quarterly 10,000 warrants to purchase the Company’s common stock at 120%
of the Company’s closing stock price on the day following the meeting. Through
June 30, 2006, the SAB was granted a total of 160,000 stock warrants exercisable
into common shares at prices from $0.18 to $2.20 per share. These warrants,
if
not exercised will expire on various dates through February 2010.
The
fair
value of these warrants in the amount of $130,084 was recorded as consulting
expense.
In
September 2005, the Company's Board of Directors authorized the issuance
of
2,200,000 shares of its common stock with a restrictive legend, as scientific
consulting compensation for development work on the Company’s anti viral
compounds. Based upon the fair market value of the common stock on the
commitment date, the Company recorded a consulting expense of $178,200.
In
September 2005, the Company's Board of Directors authorized the issuance
of
100,000 shares of its common stock with a restrictive legend, to an outside
consultant advising the Company on government procurements. Based upon the
fair
market value of the common stock on the commitment date, the Company recorded
a
consulting expense of $8,100
In
September 2005, the Company's Board of Directors authorized the issuance
of
48,177 shares of its common stock with a restrictive legend, to the debenture
holders in lieu of interest on debentures as set forth in the contract. The
Company recorded an interest expense of $4,315.
In
November and December 2005, the Company closed a private equity financing
for
proceeds of $1,370,000. The Company sold 2,740,000 shares of its common stock
at
$.50 per share. These investors also received warrants for the purchase of
1,370,000 common shares at $1.00 per share. These warrants expire on various
dates through December 2008.
The
Company allocated a relative fair value of $483,610 to these $1.00 warrants
by
using the Black-Scholes option pricing model.
In
December 2005, the Company's Board of Directors authorized the issuance of
20,000 shares of its common stock with a restrictive legend to an outside
consultant advising the Company on government procurements. Based upon the
fair
market value of the common stock on the commitment date, the Company recorded
a
consulting expense of $19,000.
In
December 2005, the Company's Board of Directors authorized the issuance of
50,000 shares of its common stock with a restrictive legend, to an investor
in
connection with debt financing. Based upon the fair market value of the common
stock on the commitment date, the Company recorded a deferred financing cost
of
$49,000, which is being amortized using the straight-line method over the
term
of the debenture.
In
December 2005, the Company's Board of Directors authorized the issuance of
19,476 shares of its common stock with a restrictive legend, to the debenture
holders in lieu of interest on debentures as set forth in the contract. The
Company recorded an interest expense of $17,340.
From
July
through December 2005, the Company issued $1,000,000 of 9% Series A convertible
debentures with warrants attached to purchase 200,000 shares of common stock
exercisable at a price per common share of $.25 (See Note 7). Interest on
these
debentures was payable quarterly in common stock and resulted in the issuance
of
90,000 shares of common stock. As of June 30, 2006 the Company recorded an
interest expense of $66,286 for the issuance of these shares. The warrants
on
these debentures were exercised in July 2006 (subsequent to the Balance Sheet
date) and resulted in proceeds to the Company of $50,000 and the issuance
of
200,000 common shares.
In
January 2006, the Company's Board of Directors authorized the issuance of
3,425
shares of its common stock with a restrictive legend, to an outside consultant
for services. Based upon the fair market value of the common stock on the
commitment date, the Company recorded a consulting expense of $5,001.
In
March
2006, the Company's Board of Directors authorized the issuance of 7,921 shares
of its common stock with a restrictive legend, to the debenture holders in
lieu
of interest on debentures as set forth in the contract. The Company recorded
an
interest expense of $22,192.
In
June
2006, the Company closed a private equity financing for proceeds of $1,875,000.
The Company sold 1,875,000 shares of its common stock. These investors also
received warrants for the purchase of 1,875,000 common shares at $2.50 per
share. These warrants expire in June 2009.
The
Company allocated a relative fair value of $779,022 of these warrants by
using
the Black-Scholes option pricing model.
In
June
2006, the Company's Board of Directors authorized the issuance of 14,426
shares
of its common stock with a restrictive legend, to the debenture holders in
lieu
of interest on debentures as set forth in the contract. The Company recorded
an
interest expense of $22,438.
Options
Granted To Officers
In
September 2005, 500,000 stock options were granted to Eugene Seymour, our
CEO
under an employment agreement. Of these options, 250,000 are vested immediately
and are exercisable from September 2005 until September 2015, and the remaining
options vest annually in two equal amounts.
In
September 2005, 1,000,000 stock options were granted to Anil Diwan, our Chairman
and President under an employment agreement. Of these options, 333,333 are
vested immediately and are exercisable from September 2005 until September
2015,
and the remaining options vest annually in two equal amounts.
In
September 2005, 500,000 stock options were granted to Leo Ehrlich, our CFO
under
an employment agreement. Of these options, 250,000 are vested immediately
and
are exercisable from September 2005 until September 2015, and the remaining
options vest annually in two equal amounts.
The
Company has accounted for these options granted to officers under the provisions
of Financial Accounting Standard No. 123 and SFAS 123R, "Accounting for Stock
Based Compensation."
Based
on
fair market value of these options, $87,318 was recognized as stock based
compensation expense, and $40,223 will be expensed over the remaining employment
term.
Note
9. Stock Options And Warrants
Stock
Options
The
following table presents the combined activity of stock options issued for
the
years ended June 30, as follows:
Stock
Options
|
|
Number
of
Shares
|
|
Weighted
Average
Exercise
Price
per
share
($)
|
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
|
Aggregate
Intrinsic
Value
($)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at May 12, 2005 (Inception)
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
3,000,000
|
|
$
|
0.86
|
|
|
2.33
|
|
$
|
-
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Expired
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Canceled
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
$
|
2,980,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
at June 30, 2006
|
|
|
833,333
|
|
$
|
0.10
|
|
|
9.25
|
|
$
|
1,241,666
|
|
As
of
June 30, 2006, there was $40,223 of unrecognized compensation cost, related
to
non-vested options granted under employment contracts, which is expected
to be
recognized over a weighted average period of 2 years.
Stock
Warrants
The
following table presents the combined activity of stock warrants issued for
the
years ended June 30, as follows:
Stock
Warrants
|
|
Number
of
Shares
|
|
Weighted
Average
Exercise
Price
per
share
($)
|
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
|
Aggregate
Intrinsic
Value
($)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at May 12, 2005 (Inception)
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
-
|
|
$
|
-
|
|
|
-
|
|
$
|
-
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Expired
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Canceled
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2005
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Granted
|
|
|
3,605,000
|
|
|
1.72
|
|
|
2.87
|
|
|
-
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Expired
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Canceled
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2006
|
|
|
3,605,000
|
|
$
|
1.72
|
|
|
2.65
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
at June 30, 2006
|
|
|
3,605,000
|
|
$
|
1.72
|
|
|
2.65
|
|
$
|
-
|
|
Of
above
warrants, 200,000 expire in fiscal year ending June 30, 2007, 3,245,000 in
fiscal year ending June 30, 2009, and 160,0000 expire in fiscal year ending
June
30, 2010.
Note
10. Income Taxes
There
was
no current or deferred income tax provision for the year ended June 30, 2006
or
for the period from May 12, 2005 (Inception) to June 30, 2005.
The
Company's deferred tax assets as of June 30 is as follows:
|
|
2006
|
|
2005
|
|
Net
operating loss carryforwards
|
|
$
|
710,800
|
|
$
|
14,900
|
|
Research
and development credit
|
|
|
234,000
|
|
|
-
|
|
Other
|
|
|
363,700
|
|
|
-
|
|
Gross
deferred tax assets
|
|
|
1,308,500
|
|
|
14,900
|
|
Valuation
allowances
|
|
|
(1,308,500
|
)
|
|
(14,900
|
)
|
Deferred
tax assets
|
|
$
|
-
|
|
$
|
-
|
|
At
June
30, 2006, the Company had potentially utilizable Federal and state net operating
loss tax carryforwards of approximately $2,417,000 which will begin to expire
in
the year 2026, if not utilized. The utilization of the Company's net operating
losses may be subject to a substantial limitation due to the "change of
ownership provisions" under Section 382 of the Internal Revenue Code and
similar
state provisions. Such limitation may result in the expiration of the net
operating loss carryforwards before their utilization. A valuation allowance
is
provided when it is more likely than not than some portion or all of the
deferred tax assets will not be realized. The net change in the total valuation
allowance for the year ended June 30, 2006 and the period from May 12, 2005
(Inception) to June 30, 2005 was an increase of $1,308,500 and $14,900,
respectively. The tax benefit assumed using the Federal statutory tax rate
of
34% and Connecticut statutory rate of 7.5% has been reduced to an actual
benefit
of zero due principally to the aforementioned valuation
allowance.
Note
11. Commitments and Contingencies
The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 1500 square feet of office
space
at a base monthly rent of $1,875. The lease expires February 2007.
The
Company is
dependent
upon its license agreement with TheraCour Pharma, Inc. (See Note 4). If it
losses the right to utilize any of the proprietary information that is the
subject of the TheraCour Pharma license agreement on which it depends, the
Company will incur substantial delays and costs in development of its drug
candidates.
The
Company, in September 2005, signed employment agreements with its three
executive officers to pay minimum annual base salaries of $200,000 each for
three years. This base salary will increase to $250,000 per year upon closing
of
a financing to the company with gross proceeds of at least $5,000,000. In
addition to salary, the Company is obligated to pay health and life insurance
benefits and reimburse expenses incurred by the officers on behalf of the
company. The Company also granted stock options as part of these employment
agreements. (See Note 8.) Each
executive officer, if terminated by the Company without cause, would be entitled
six months salary ($100,000) as severance compensation.
While
no
legal actions are currently pending, the Company may be party to certain
claims
brought against it arising from certain contractual matters. It is not possible
to state the ultimate liability, if any, in these matters. In management’s
opinion, the ultimate resolution of any such claim will not have a material
adverse effect on the financial position of the Company.
Note
12. Subsequent Events
During
July 2006, convertible debentures in the amount of $1,000,000 were converted
into common stock, resulting in the issuance of 3,333,333 common shares.
(See
Note 7).
(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEETS
|
|
September
30, 2006
|
|
June
30, 2006
|
|
|
|
Unaudited
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
1,777,479
|
|
$
|
2,507,102
|
|
Prepaid
expenses
|
|
|
290,227
|
|
|
213,728
|
|
Total
current assets
|
|
|
2,067,706
|
|
|
2,720,830
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
1,942
|
|
|
2,054
|
|
|
|
|
|
|
|
|
|
Deferred
expenses, net
|
|
|
-
|
|
|
6,714
|
|
Trademarks,
net
|
|
|
3,185
|
|
|
-
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$
|
2,072,833
|
|
$
|
2,729,598
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Accounts
payable - trade
|
|
$
|
30,055
|
|
$
|
44,076
|
|
Accounts
payable - related parties
|
|
|
151,613
|
|
|
203,045
|
|
Accrued
expenses
|
|
|
73,108
|
|
|
90,831
|
|
Accrued
payroll to officers and related payroll tax expense
|
|
|
217,222
|
|
|
232,282
|
|
Other
payroll taxes payable
|
|
|
3,223
|
|
|
3,826
|
|
TOTAL
CURRENT LIABILITIES
|
|
|
475,221
|
|
|
574,060
|
|
|
|
|
|
|
|
|
|
LONG
TERM DEBT:
|
|
|
|
|
|
|
|
Debentures,
net
|
|
|
-
|
|
|
917,082
|
|
TOTAL
LIABILITIES
|
|
|
475,221
|
|
|
1,491,142
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’
EQUITY
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value; 300,000,000 shares authorized at September
30,
2006 and June 30,2006
;
issued and outstanding: 112,417,502 at September 30, 2006 and 108,878,425
at June 30, 2006.
|
|
|
112,417
|
|
|
108,878
|
|
Additional
paid-in capital
|
|
|
5,576,024
|
|
|
4,480,035
|
|
Stock
subscription receivable
|
|
|
(20
|
)
|
|
(20
|
)
|
Deficit
accumulated during the development stage
|
|
|
(4,090,809
|
)
|
|
(3,350,437
|
)
|
TOTAL
SHAREHOLDERS’ EQUITY
|
|
|
1,597,612
|
|
|
1,238,456
|
|
TOTAL
LIABILITIES AND
SHAREHOLDERS’
EQUITY
|
|
$
|
2,072,833
|
|
$
|
2,729,598
|
|
The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended September 30, 2006
|
|
Three
Months Ended September 30, 2005
|
|
For
the Cumulative Period
From
May 12, 2005 (Inception) through
September
30, 2006
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
184,885
|
|
|
125,088
|
|
|
1,115,547
|
|
General
and administrative (of this amount $41,884, $244,495, and $469,587
was for
stock and option based compensation to consultants and officers
for each
period presented)
|
|
|
488,109
|
|
|
325,653
|
|
|
2,219,300
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
672,994
|
|
|
450,741
|
|
|
3,334,847
|
|
Loss
from operations
|
|
|
(672,994
|
)
|
|
(450,741
|
)
|
|
(3,334,847
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expenses):
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
23,184
|
|
|
-
|
|
|
31,047
|
|
Non
cash interest on convertible debentures
|
|
|
(7,644
|
)
|
|
(4,315
|
)
|
|
(73,930
|
)
|
Non
cash interest expense on beneficial conversion feature
|
|
|
|
|
|
|
|
|
|
|
of
convertible debentures
|
|
|
(82,918
|
)
|
|
(1,975
|
)
|
|
(713,079
|
|
Total
other expenses
|
|
|
(67,378
|
)
|
|
(6,290
|
)
|
|
(755,962
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(740,372
|
)
|
$
|
(457,031
|
)
|
$
|
(4,090,809
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share: basic and diluted
|
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
$
|
(0.04
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding: basic and diluted
|
|
|
111,224,987
|
|
|
100,175,000
|
|
|
104,822,358
|
|
The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIT)
FOR
THE CUMULATIVE PERIOD MAY 12, 2005 (INCEPTION) THROUGH SEPTEMBER 30,
2006
(UNAUDITED)
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
Number
of
Shares
|
|
Par
Value
$.001
|
|
Additional
Paid-in
Capital
|
|
Stock
Subscription
Receivable
|
|
Accumulated
Deficit
|
|
Total
Shareholders'
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
|
)
|
|
-
|
|
|
-
|
|
|
-
|
|
Options
granted in connection with reverse acquisition
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Net
loss period ended June 30, 2005
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(66,005
|
)
|
|
(66,005
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at June 30, 2005
|
|
|
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
|
|
The
accompanying notes are an integral part of these financial
statements.
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
Number
of S
hares
|
|
Par
Value
$.001
|
|
Additional
Paid-in
Capital
|
|
Stock
Subscription
Receivable
|
|
Accumulated
Deficit
|
|
Total
Shareholders'
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
|
|
The
accompanying notes are an integral part of these financial
statements.
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
Number
Of
hares
|
|
Par
Value
$.001
|
|
Additional
Paid-in
Capital
|
|
Stock
Subscription
Receivable
|
|
Accumulated
Deficit
|
|
Total
Shareholders'
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
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
issued to Scientific Advisory Board on August 15, 2006
|
|
|
-
|
|
|
-
|
|
|
30,184
|
|
|
-
|
|
|
-
|
|
|
30,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
of deferred compensation
|
|
|
|
|
|
|
|
|
11,700
|
|
|
|
|
|
|
|
|
11,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss three months ended September 30, 2006.
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(740,372
|
)
|
|
(740,372
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at September 30, 2006
|
|
|
112,417,502
|
|
$
|
112,417
|
|
$
|
5,576,024
|
|
$
|
(20
|
)
|
$
|
(4,090,809
|
)
|
$
|
1,597,612
|
|
The
accompanying notes are an integral part of these financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS
(UNAUDITED)
|
|
Three
Months Ended September 30, 2006
|
|
Three
Months Ended September 30, 2005
|
|
For
the Cumulative Period
From
May 12, 2005 (Inception) through
September
30, 2006
|
|
|
|
|
|
|
|
|
|
OPERATING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(740,372
|
)
|
$
|
(457,031
|
)
|
$
|
(4,090,809
|
)
|
Adjustments
to reconcile net loss to net cash used
in
operating activities:
|
|
|
|
|
|
|
|
|
|
|
Shares
issued for services rendered
|
|
|
-
|
|
|
186,300
|
|
|
210,301
|
|
Warrants
granted to scientific advisory board
|
|
|
30,184
|
|
|
4,094
|
|
|
160,268
|
|
Options
issued to officers as compensation
|
|
|
11,700
|
|
|
52,601
|
|
|
99,018
|
|
Depreciation
and amortization
|
|
|
127
|
|
|
-
|
|
|
221
|
|
Amortization
of deferred financing expenses
|
|
|
6,714
|
|
|
363
|
|
|
51,175
|
|
Non
cash interest on convertible debentures
|
|
|
7,644
|
|
|
4,315
|
|
|
73,930
|
|
Non
cash interest expense on beneficial conversion feature of convertible
debentures
|
|
|
82,918
|
|
|
1,975
|
|
|
713,079
|
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(76,499
|
)
|
|
-
|
|
|
(290,227
|
)
|
Deferred
expenses
|
|
|
-
|
|
|
(2,175
|
|
|
(2,175
|
)
|
Accounts
payable- trade
|
|
|
(14,021
|
)
|
|
14,673
|
|
|
30,055
|
|
Accounts
payable -related parties
|
|
|
(51,432
|
)
|
|
22,865
|
|
|
151,613
|
|
Accrued
expenses
|
|
|
(17,723
|
)
|
|
(7,524
|
|
|
73,108
|
|
Accrued
payroll to officers and related payroll tax expense
|
|
|
(15,060
|
)
|
|
-
|
|
|
217,222
|
|
Other
payroll taxes payable
|
|
|
(603
|
)
|
|
-
|
|
|
3,223
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(776,423
|
)
|
|
(179,544
|
)
|
|
(2,599,998
|
)
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Purchases
of property and equipment
|
|
|
-
|
|
|
-
|
|
|
(2,148
|
)
|
Purchase
of trademarks
|
|
|
(3,200
|
)
|
|
-
|
|
|
(3,200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(3,200
|
)
|
|
-
|
|
|
(5,348
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of convertible debentures
|
|
|
-
|
|
|
275,000
|
|
|
1,000,000
|
|
Proceeds
from issuance of common stock and warrants in connection with private
placements of common stock - net of fees
|
|
|
-
|
|
|
-
|
|
|
3,242,825
|
|
Proceeds
from exercise of stock warrants attached to convertible
debentures
|
|
|
50,000
|
|
|
-
|
|
|
50,000
|
|
Proceeds
from exercise of stock options
|
|
|
-
|
|
|
-
|
|
|
90,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
50,000
|
|
|
275,000
|
|
|
4,382,825
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
(729,623
|
|
|
95,456
|
|
|
1,777,479
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, BEGINNING
|
|
|
2,507,102
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, ENDING
|
|
$
|
1,777,479
|
|
$
|
95,456
|
|
$
|
1,777,479
|
|
The
accompanying notes are an integral part of these financial
statements.
NANOVIRICIDES,
INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENTS
OF CASH FLOWS (CONTINUED)
SUPPLEMENTAL
DISCLOSURE OF NON-CASH ACTIVITY
(UNAUDITED)
During
the three months ended September 30, 2006 and 2005, the Company had the
following non-cash activity:
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
Common
stock issued for services rendered
|
|
$
|
-
|
|
$
|
178,200
|
|
|
|
|
|
|
|
|
|
Common
stock issued for legal services rendered
|
|
|
-
|
|
|
8,100
|
|
|
|
|
|
|
|
|
|
Stock
options issued to the officers as compensation
|
|
|
11,700
|
|
|
52,601
|
|
|
|
|
|
|
|
|
|
Stock
warrants granted to scientific advisory board
|
|
|
30,184
|
|
|
4,094
|
|
|
|
|
|
|
|
|
|
Common
stock issued for interest on debentures
|
|
|
7,644
|
|
|
4,315
|
|
|
|
|
|
|
|
|
|
Common
stock issued upon conversion of convertible debentures
|
|
|
1,000,000
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Debt
discount related to beneficial conversion feature of convertible
debt
|
|
|
-
|
|
|
10,579
|
|
The
accompanying notes are an integral part of these financial
statements
.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO FINANCIAL STATEMENTS
SEPTEMBER
30, 2006 AND 2005
(Unaudited)
Note
1. Basis of Presentation
The
unaudited financial statements included herein have been prepared pursuant
to
the rules and regulations of the Securities and
Exchange
Commission (“SEC”) for interim reporting, and in the opinion of management
reflect all adjustments, including those of a
normal
recurring nature, that are necessary for a fair presentation of financial
position and results of operations for the interim periods
presented.
As permitted under those requirements, certain footnotes or other financial
information that are normally required by
accounting
principles generally accepted in the United States of American have been
condensed or omitted.
Note
2. Organization and Nature of Business
NanoViricides,
Inc. was incorporated under the laws of the State of Colorado on July 25,
2000
as Edot-com.com, Inc
.
and
was
organized for the purpose of conducting internet retail sales. On April 1,
2005,
Edot-com.com, Inc
.
was
incorporated under the laws of the State of Nevada for the purpose of
re-domiciling the Company as a Nevada corporation. On May 12, 2005, the
Corporations were merged and Edot-com.com, Inc
.,
a
Nevada
corporation, (the Company), became the surviving entity.
On
June
1, 2005, Edot-com.com, Inc. (“ECMM”) acquired Nanoviricide, Inc., a privately
owned Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share
Exchange (the “Exchange”). Nanoviricide, Inc. was incorporated under the laws of
the State of Florida on May 12, 2005.
Pursuant
to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate
of
80,000,000 newly issued shares of ECMM common stock resulting in an aggregate
of
100,000,000 shares of ECMM common stock issued and outstanding. NVI then
became
a wholly-owned subsidiary of ECMM. The ECMM shares were issued to the NVI
Shareholders on a pro rata basis, on the basis of 4,000 shares of the Company’s
Common Stock for each share of NVI common stock held by such NVI Shareholder
at
the time of the Exchange.
As
a
result of the Exchange Transaction the former NVI stockholders held
approximately 80% of the voting capital stock of the Company immediately
after
the Exchange Transaction. For financial accounting purposes, this acquisition
was a reverse acquisition of the Company by NVI, under the purchase method
of
accounting, and was treated as a recapitalization with NVI as the acquirer.
Accordingly, the financial statements have been prepared to give retroactive
effect to May 12, 2005 (date of inception), of the reverse acquisition completed
on June 01, 2005, and represent the operations of NVI.
On
June
28, 2005, NVI was merged into its parent ECMM and the separate corporate
existence of NVI ceased. Effective on the same date, EDOT-COM.COM, Inc. changed
its name to NanoViricides, Inc. and its stock symbol to “NNVC”, respectively.
The Company is considered a development stage company at this time.
NanoViricides,
Inc. (the “Company”), is a nano-biopharmaceutical company whose business goals
are to discover, develop and commercialize therapeutics to advance the care
of
patients suffering from life-threatening viral infections. We are a development
stage company with several drugs in various stages of early development.
Our
drugs are based on several patents, patent applications, provisional patent
applications, and other proprietary intellectual property held by TheraCour
Pharma, Inc., to which we have the necessary licenses in perpetuity for the
treatment of the following human viral diseases: Human Immunodeficiency Virus
(HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex
Virus (HSV), Influenza, Rabies and Asian Bird Flu Virus. We focus our research
and clinical programs on specific anti-viral solutions. We are seeking to
add to
our existing portfolio of products through our internal discovery and clinical
development programs and through an in-licensing strategy.
To date,
the Company has not developed any commercial products.
Note
3 -
Substantial
Doubt Regarding Ability to Continue as a Going Concern
Since
May
2005, the Company has been engaged exclusively in research and development
activities focused on developing targeted nano viral drugs. The Company has
not
yet commenced any product commercialization. The Company has incurred
significant operating losses since its inception, resulting in an accumulated
deficit of $4,090,809 at September 30, 2006. Such losses are expected to
continue for the foreseeable future and until such time, if ever, as the
Company
is able to attain sales levels sufficient to support its operations. There
can
be no assurance that the Company will achieve or maintain profitability in
the
future. Despite the Company’s financings in 2006 and 2005 and a cash balance of
$1,777,479 at September 30, 2006, substantial additional financing will be
required in future periods, as the Company believes it will require in excess
of
$5,000,000 to fund its operations during the next twelve months.
We
have
planned in-vivo and in-vitro studies during the first quarter of 2007.
Thereafter, we plan to release the data from these studies and seek
substantial
additional financing
to
meet
our planned cash requirements through private placements of our common stock
and/or incurring debt. No assurances can be given that financing will be
available or be sufficient to meet our capital needs. If we are unable to
obtain
financing to meet our working capital requirements, then we may be required
to
modify our operations, including curtailing our business significantly or
ceasing operations altogether.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern which contemplates the realization of assets
and the satisfaction of liabilities in the normal course of business.
Accordingly, they do not include any adjustments relating to the realization
of
the carrying value of assets or the amounts and classification of liabilities
that might be necessary should the company be unable to continue as a going
concern. The Company’s significant operating losses and significant capital
requirements, however, raise substantial doubt about the Company’s ability to
continue as a going concern.
Note
4. Significant Alliances and Related Parties
TheraCour
Pharma, Inc.
Pursuant
to an Exclusive License Agreement we entered into with TheraCour Pharma,
Inc.,
(TheraCour), the Company was granted an exclusive licenses in perpetuity
for
technologies developed by TheraCour for the virus types: HIV, HCV, Herpes,
Asian
(bird) flu, Influenza and rabies. In consideration for obtaining this exclusive
license, we agreed: (1) that TheraCour can charge its costs (direct and
indirect) plus no more than 30% of direct costs as a Development Fee and
such
development fees shall be due and payable in periodic installments as billed.
(2) we will pay $25,000 per month for usage of lab supplies and chemicals
from
existing stock held by TheraCour, (3) we will pay $2,000 or actual costs,
whichever is higher for other general and administrative expenses incurred
by
TheraCour on our behalf (4) make royalty payments (calculated as a percentage
of
net sales of the licensed drugs) of 15% to TheraCour Pharma, Inc. (5) that
TheraCour Pharma, Inc. retain the exclusive right to develop and synthesize
nanomicelle(s), a small (approximately twenty nanometers in size) long chain
polymer based chemical structure, as component elements of the Licensed
Products. TheraCour Agreed that it will develop and synthesize such nanomicelle
exclusively for NanoViricides, and unless such license is terminated, will
not
develop or synthesize such nanomicelle for its own sake or for others; and
(6)
TheraCour may request and NanoViricides, Inc. will pay an advance payment
equal
to twice the amount of the previous months invoice to be applied as a prepayment
towards expenses.
TheraCour
Pharma, Inc.,
may
terminate the license upon a material breach by us as specified in the
agreement. However, we may avoid such termination if within 90 days of receipt
of such termination notice we cure the breach.
Development
costs charged by TheraCour Pharma, Inc. was $877,777 since inception through
September 30, 2006, and was $184,885 and $125,088 for the three months ended
September 30, 2006 and 2005, respectively. No royalties have been paid through
the year ended September 30, 2006.
TheraCour
Pharma, Inc., is affiliated with the Company through the common control of
it
and our Company by Anil Diwan, President, and Leo Ehrlich, CFO, who are
directors of each corporation, and own approximately 75% of the capital stock
of
TheraCour Pharma, Inc., which itself owns approximately 31% of the capital
stock
of the Company.
TheraCour
Pharma, Inc. owns 35,370,000 shares of the Company’s outstanding common stock as
of September 30, 2006.
KARD
Scientific, Inc.
In
June
2005, the Company engaged KARD Scientific to conduct pre clinical
human
influenza animal (mouse) studies
and
provide the Company with a full history of the study and final report with
the
data collected. This project is on-going. NanoViricides has a fee for service
arrangement with KARD. We do not have an exclusive arrangement with KARD;
we do
not have a contract with Kard; and all work performed by Kard must have prior
approval of the executive officers of NanoViricides. Dr. Krishna Menon, the
Company’s Chief Regulatory Officer, a non-executive officer position, is also an
officer and principal owner of KARD Scientific. Lab fees charged by KARD
Scientific for services from inception to September 30, 2006 amounted to
$206,499, and for the three months ended September 30, 2006 and 2005, were
$0
and $0 respectively. The Company also has paid KARD a $50,000 advance payment
towards future fees.
Note
5. Prepaid Expenses
Prepaid
expenses are summarized as follows:
|
|
September
30, 2006
|
|
June
30, 2006
|
|
|
|
|
|
|
|
TheraCour
Pharma, Inc. *
|
|
$
|
210,227
|
|
$
|
163,728
|
|
Kard
Scientific, Inc. *
|
|
|
50,000
|
|
|
50,000
|
|
Prepaid
Legal Fees
|
|
|
30,000
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
$
|
290,227
|
|
$
|
213,728
|
|
(*
See
Note 4. Significant Alliances and Related Parties)
Note
6. Equity Transactions
In
July
2006, the Company's Board of Directors authorized the issuance of 5,744 shares
of its common stock with a restrictive legend, to the debenture holders in
lieu
of interest on debentures as set forth in the contract. The Company recorded
an
interest expense of $7,644.
In
July
2006, warrants to purchase 200,000 shares of common stock exercisable at
a price
per common share of $.25 were exercised, and proceeds of $50,00 were
received.
In
July
2006, convertible debentures in the amount of $1,000,000 were converted into
common stock, resulting in the issuance of 3,333,333 common
shares.
In
August
2006, the Scientific Advisory Board (SAB) was granted a total of 40,000 warrants
exercisable into common shares at $1.36 per share. These warrants, if not
exercised will expire in August 2010.
The
fair
value of these warrants in the amount of $30,184, was recorded as consulting
expense.
Note
7. Stock Options And Warrants
Stock
Options
The
following table presents the combined activity of stock options issued for
the
three months ended September 30, 2006 as follows:
Stock
Options
|
|
Number
of
Shares
|
|
Weighted
Average
Exercise
Price
per share ($)
|
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
|
Aggregate
Intrinsic
Value
($)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2006
|
|
|
2,000,000
|
|
|
0.10
|
|
|
9.25
|
|
|
2,980,000
|
|
Granted
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Expired
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Canceled
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2006
|
|
|
2,000,000
|
|
$
|
0.10
|
|
|
9.00
|
|
$
|
2,180,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
at September 30, 2006
|
|
|
833,333
|
|
$
|
0.10
|
|
|
9.00
|
|
$
|
908,333
|
|
As
of
September 30, 2006, there was $28,523 of unrecognized compensation cost,
related
to non-vested options granted under employment contracts, which is expected
to
be recognized over a weighted average period of less than 2 years.
Stock
Warrants
The
following table presents the combined activity of stock warrants issued for
the
three months ended September 30, 2006 as follows:
Stock
Warrants
|
|
Number
of
Shares
|
|
Weighted
Average
Exercise
Price
per share ($)
|
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
|
Aggregate
Intrinsic
Value
($)
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2006
|
|
|
3,605,000
|
|
|
1.72
|
|
|
2.65
|
|
|
-
|
|
Granted
|
|
|
40,000
|
|
|
1.36
|
|
|
4.00
|
|
|
-
|
|
Exercised
|
|
|
(200,000
|
|
|
.25
|
|
|
-
|
|
|
-
|
|
Expired
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Canceled
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2006
|
|
|
3,445,000
|
|
$
|
1.84
|
|
|
2.52
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
at September 30, 2006
|
|
|
3,445,000
|
|
$
|
1.84
|
|
|
2.52
|
|
$
|
-
|
|
Of
above
warrants, 3,245,000 expire in fiscal year ending June 30, 2009, and 160,0000
expire in fiscal year ending June 30, 2010, 40,000 expire in fiscal year
ending
June 30, 2011.
Note
8. Income Taxes
There
was
no current or deferred income tax provision for the three months ended September
30, 2006 and 2005.
The
Company's deferred tax assets is summarized as follows:
|
|
September
30, 2006
|
|
June30,
2006
|
|
Net
operating loss carryforwards
|
|
$
|
856,000
|
|
$
|
710,800
|
|
Research
and development credit
|
|
|
325,000
|
|
|
234,000
|
|
Other
|
|
|
423,500
|
|
|
363,700
|
|
Gross
deferred tax assets
|
|
|
1,604,500
|
|
|
1,308,500
|
|
Valuation
allowances
|
|
|
(1,604,500
|
)
|
|
(1,308,500
|
)
|
Deferred
tax assets
|
|
$
|
-
|
|
$
|
-
|
|
At
September 30, 2006, the Company had potentially utilizable Federal and state
net
operating loss tax carryforwards of approximately $3,000,000 which will begin
to
expire in the year 2026, if not utilized. The utilization of the Company's
net
operating losses may be subject to a substantial limitation due to the "change
of ownership provisions" under Section 382 of the Internal Revenue Code and
similar state provisions. Such limitation may result in the expiration of
the
net operating loss carryforwards before their utilization. A valuation allowance
is provided when it is more likely than not than some portion or all of the
deferred tax assets will not be realized. The net change in the total valuation
allowance for the three months ended September 30, 2006 and the year ended
June
30, 2006 was an increase of $296,000 and $1,293,600, respectively. The tax
benefit assumed using the Federal statutory tax rate of 34% and Connecticut
statutory rate of 7.5% has been reduced to an actual benefit of zero due
principally to the aforementioned valuation allowance.
Note
9. Commitments and Contingencies
The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 1500 square feet of office
space
at a base monthly rent of $1,875. The lease expires February 2007.
The
Company is
dependent
upon its license agreement with TheraCour Pharma, Inc. (See Note 4). If it
losses the right to utilize any of the proprietary information that is the
subject of the TheraCour Pharma license agreement on which it depends, the
Company will incur substantial delays and costs in development of its drug
candidates.
The
Company, in September 2005, signed employment agreements with its three
executive officers to pay minimum annual base salaries of $200,000 each for
three years. This base salary will increase to $250,000 per year upon closing
of
a financing to the company with gross proceeds of at least $5,000,000. In
addition to salary, the Company is obligated to pay health and life insurance
benefits and reimburse expenses incurred by the officers on behalf of the
company. The Company also granted stock options as part of these employment
agreements. Each
executive officer, if terminated by the Company without cause, would be entitled
six months salary ($100,000) as severance compensation.
While
no
legal actions are currently pending, the Company may be party to certain
claims
brought against it arising from certain contractual matters. It is not possible
to state the ultimate liability, if any, in these matters. In management’s
opinion, the ultimate resolution of any such claim will not have a material
adverse effect on the financial position of the Company.
Note
10. Subsequent Events
On
January 8, 2007 TheraCour Pharma, Inc. and the Company amended their license
agreement and added rabies to other virus types to which a license in perpetuity
had been previously granted. In addition Paragraphs 2, 2.1 and 2.2 of
the license agreement pertaining to exclusive manufacturing rights by TheraCour
were amended and as follows:
The
license grant in paragraph 2 is amended and restated as follows:
1)
|
License
Grant. TheraCour hereby grants to Nano a limited, non-transferable,
exclusive license, subject to the provision of paragraph 2.2
amended
below, for the manufacture, use, sale, or offer of sale of the
Licensed
Product(s) in the Territory.
|
2)
|
Paragraph
2.1 of the said License Agreement is amended to include
“
Rabies
Virus
”
.
|
3)
|
Paragraph
2.2 of said License Agreement is clarified, superseded and replaced
by the
following paragraph:
|
“TheraCour
retains exclusive rights to develop and synthesize the different TheraCour
base
polymers used for making the various nanoviricides. A TheraCour base polymer
is
defined as a polymer that does not have the virus-specific ligand attached
to it
as yet and its structure is covered in one or more of the specified TheraCour
patents. TheraCour also retains the exclusive rights to research and develop
the
chemistries for attaching the virus-specific ligands to the base polymers.
A
“ligand” is defined herein as a chemical or biological moiety that is capable of
binding to some feature of the targeted virus particle, this enabling targeting
to a specific strain, subtype, type or class of virus, or broad or multiple
classes of viruses. A ligand itself may be a small chemical moiety, a peptide
moiety, a fragment of any antibody, an RNA or DNA “aptamer”, or another
chemically defined structure. A TheraCour base polymer is also referred to
herein as a “nanomicelle”. A nanomicelle is thus a component element of the
Licensed Products. Further, TheraCour agrees to identify, design, and develop
ligand(s) necessary for the development of the Licensed Products. As to any
Licensed Product, TheraCour retains the initial exclusive right to develop
and
synthesize the nanomicelles exclusively for Nano. In the event that Theracour
is
unable to supply the quantities of the nanomicelle(s) required for manufacture
of the Licensed Product(s), then upon notice and after any applicable cure
periods required under the License agreement, Nano can acquire the
nanomicelle(s) from other third party providers.
PART
III
Item
1.
Index to Exhibits
An
index
to and description of the financial statements filed as part of this Form
10-SB
is contained in the section above.
Exhibit
No.
|
|
Description
|
|
|
|
3.1*
|
|
Articles
of Incorporation, as amended, of the Registrant
|
3.2*
|
|
By-laws
of the Registrant
|
|
|
|
4.1*
|
|
Specimen
Stock Certificate of the Registrant
|
4.2*
|
|
Series
A Convertible Debenture
|
4.3*
|
|
Form
of Warrant
|
10.1*
|
|
Share
Exchange Agreement between NanoViricide, Inc. and the
Registrant
|
10.2*
|
|
Employment
agreement ES
|
10.3*
|
|
Employment
agreement AD
|
10.4*
|
|
Employment
agreement LE
|
10.5*
|
|
Form
of Scientific Advisory Board Agreement
|
10.6*
|
|
Amended
License Agreement with TheraCour Pharma, Inc.
|
10.7*
|
|
Lease
with landlord
|
10.8*
|
|
Form
of First Subscription Agreement
|
10.9*
|
|
Form
of Second Subscription Agreement
|
10.10*
|
|
Code
of Ethics
|
|
|
Amended
Material License Agreement #2 with TheraCour Pharma,
Inc.
|
10.12+
|
|
Memorandum
of Understanding with Vietnam’s National Institute of Hygiene and
Epidemiology (NIHE) dated December 23, 2005
|
|
|
Memorandum from
David F. Gencarelli (Confidential Treatment
Requested)
|
*
Incorporated by reference to the Company’s registration statement on Form 10-SB,
filed with the Securities Commission on November 14, 2006.
+
Filed
Herewith
SIGNATURES
Pursuant
to the requirements of Section 12 of the Securities and Exchange Act of 1934,
the Registrant has duly caused this registration statement to be signed on
its
behalf by the undersigned, thereunto duly authorized on January 16,
2007.
|
NANOVIRICIDES,
INC.
|
|
|
|
/s/
Eugene Seymour, MD
|
|
Eugene
Seymour, MD
|
|
Chief
Executive Officer
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Registration
Statement has been signed by the following persons in the capacities indicated
on January 16, 2007.
Signature
|
|
Title
|
|
|
|
|
|
|
/s/
Eugene Seymour, MD
|
|
Chief
Executive Officer
|
Eugene
Seymour, MD
|
|
|
|
|
|
/s/
Anil Diwan, Ph.D.
|
|
President,
Director
|
Anil
Diwan, Ph.D.
|
|
|
|
|
|
/s/
Leo Ehrlich
|
|
Chief
Financial Officer
|
Leo
Ehrlich
|
|
|
100