UNITED
STATES


SECURITIES
AND EXCHANGE COMMISSION


WASHINGTON,
D.C. 20549








FORM
10-K





S ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE


SECURITIES
EXCHANGE ACT OF 1934





FOR THE
FISCAL YEAR ENDED JUNE 30, 2008





OR





£ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE


SECURITIES
EXCHANGE ACT OF 1934


FOR THE
TRANSITION PERIOD FROM _____ TO __________








COMMISSION
FILE NO. 0-29015





NANOVIRICIDES,
INC.


(Name of
Business Issuer in Its Charter)





NEVADA
                  
                  76-0674577(State
      or other jurisdiction of incorporation or organization)
                  
                  (I.R.S.
      Employer
Identification No.)








135 WOOD
STREET, SUITE 205





WEST
HAVEN, CONNECTICUT 06516





(Address
of principal executive offices)





203-937-6137





(Issuer's
telephone number, including area code)





SECURITIES
REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE





SECURITIES
REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:





COMMON
      STOCK, PAR VALUE $.001 PER SHARE
                  
                  NONE(Title
      of Class)
                  
                  (Name
      of exchange on which
registered)





Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.


Yes £No S







1
 Table of Contents




Indicate
by a check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act.
 
 Yes    £      No    S
 
 Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
 
 Yes    S      No    £
 
 Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K.  S
  Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definitions of “large accelerated filer”, “accelerated filer”, or “smaller
reporting company in Rule 12b-2 of the Exchange Act (check one):
 
 Large
      accelerated filer    £
                
                Accelerated
      filer    £Non-accelerated
      filer    £
                
                Smaller
      reporting Company    S
 
 Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act.).
 
 Yes    £      No    S
 
 As of
October 8, 2008, there were 122,651,981 shares of common stock of the
registrant issued and outstanding.
 
 The
aggregate market value of the voting stock held on June 30, 2008 by
non-affiliates of the registrant was $90,942,934 based on the closing price of
$1.38 per share as reported on the OTC Bulletin Board on June 30, 2008, the last
business day of the registrant's most recently completed fiscal year (calculated
by excluding all shares held by executive officers, directors and holders known
to the registrant of five percent or more of the voting power of the
registrant's common stock, without conceding that such persons are "affiliates"
of the registrant for purposes of the federal securities
laws).





2




TABLE OF CONTENTS





PART
      IItem
      1.
                
                Description of Business
                
                4Item
      1A
                
                Risk
      Factors
                
                30Item
      1B
                
                Unresolved Staff Comments
                
                49Item
      2.
                
                Properties
                
                49Item
      3.
                
                Legal
      Proceedings
                
                50Item
      4.
                
                Submission of Mattersto a Vote of Security
      Holders
                
                50PART
      IIItem
      5.
                
                Market for the
      Registrant’s Common Equity, Related Stockholder
      Matters and Issuer Purchases of Equity
    Securities
                
                50Item
      6.
                
                Selected Financial Data
                
                53Item
      7.
                
                Management’s Discussion
      and Analysis of Plan of Operation
                
                53Item
      7A
                
                Quantitative and Qualitative Disclosures About Market
      Risk
                
                65Item
      8.
                
                Financial Statements
      and Supplementary Data
                
                65Item
      9.
                
                Changes in and Disagreements with
      Accountants on Accounting and Financial
    Disclosure
                
                65Item
      9A(T)
                
                Controls and
      Procedures
                
                67Item
      9B.
                
                Other
      InformationPART
      IIIItem
      10.
                
                Directors, Executive Officers,
      Promoters and Control Persons, Compliance with Section 16(A) of the
      Exchange Act.
                
                67Item
      11.
                
                Executive
      Compensation
                
                68Item
      12.
                
                Security Ownership of Certain
      Beneficial Owners and Management and Related Stockholder
      Matters
                
                70Item
      13.
                
                Certain Relationships and Related Transactions and
      Director independence
                
                72Item
      14.
                
                Principal Accountant Fees and
      Services
                
                73PART
      IVItem
      15.
                
                Exhibits, Financial Statement
      Schedules
                
                74SIGNATURES
                
                75




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 Table of Contents





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., (“TheraCour,” 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 submitted a Form-10SB to the SEC
to become a reporting company on November 14, 2006. The Company’s filing status
became effective in March, 2007.  On June 28, 2007, the company became
quotedable on The OTC Bulletin Board under the symbol NNVC.OB. The Company is
considered a development stage company at this time.





4
 Table of Contents





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. Additionally, TheraCour has permitted
the Company to use its nanomaterials to develop a treatment against Dengue Fever
viruses, Ebola/Marburg viruses, and viruses causing certain eye diseases. The
Company anticipates negotiating with TheraCour an amendment to the Licensing
Agreement to include those of these additional viruses that the Company
determines it wants to follow for further development. 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 $9,207,737 at June 30, 2008. For the year ended
June 30, 2008 the Company had a net loss of $2,738,337. 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 F-1 through F-24 of this Form 10-K
have been prepared assuming that the Company will continue as a going concern
that contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. Accordingly, they do not reflect 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.





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.





Nanoviricide(TM)– is an agent which is
made by attaching ligands against a certain virus or family of viruses to a
nanomicelle based on the Company's patent-pending and proprietary
technologies.





Ligand- is a short peptide or
chemical molecule fragment 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
polymeric micelle forms from a polymer whose chemical constitution is such that
even a single chain of the polymer forms a micelle. A pendant polymer is a
polymer that 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, and naturally form
exceptionally well-defined, self-assembling, globular micelles with a core-shell
architecture.





Mutations- The ability (of a
virus) to change its genetic structure to avoid the body’s natural defenses.
Mutants are viruses created from a parent virus strain through a process of
natural selection under pressure as it replicates in a host.





P-Value: In statistical hypothesis
testing, the p-valueis the probability of
obtaining a result at least as extreme as that obtained, assuming that the null
hypothesis is true; wherein the truth of the null hypothesis states that the
finding was the result of chance alone. The fact that p-values are based on this
assumption is crucial to their correct interpretation. The smaller the p-value,
the greater is the probability that the observed study results and the
comparison control are distinct, and therefore that the study results are not a
result of chance alone.





5
 Table of Contents





More
technically, the p-value of an observed value observed of some random
variable T used as a test statistic is the probability that, given that the null
hypothesis true, T will assume a value as or more unfavorable to the null
hypothesis as the observed value observed. “More unfavorable
to the null hypothesis” can in some cases mean greater than, in some cases less
than and in some cases further away from a specified center value.





The NanoViricideConcept





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 its genome (RNA/DNA).





Background:
The NanoViricides Technology and Approach





The
NanoViricides Technology and Approach





Nanoviricide
drugs, which are presently in a preclinical stage of development, are designed
to lead to reduction in viremia by a set of novel, 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. Most existing anti-viral agents act inside human cells. It
      is believed that this mechanism leads to significant opportunities for
      non-specific effects against host cells. Nanoviricides, on the other hand,
      are designed to work directly against virus particles in bodily fluids.
      The Company believes that this approach may make nanoviricides inherently
      safer than existing approaches.








2
            A
      nanoviricide is designed to seek and attach to a specific virus particle,
      engulfing the virus particle in the process, thereby rendering it
      incapable of infecting new cells, and disabling it completely. This
      suggested mechanism of action comprises much more than what the current
      entry and fusion inhibitors are expected to do. The fusion and entry
      inhibitors do not completely cover the virus particle and likely block
      only a few sites on the virus particle, which means the virus particle may
      still be capable of infecting cells using its unblocked attachment sites.
      In contrast, a nanoviricide is expected to engulf the virus particle
      completely, because of its larger size and flexible nature, thus disabling
      it completely. The action of a nanoviricide, if it works as designed, in
      this regard may be expected to be superior to antibody agents that attack
      viruses as well. Antibodies, being large, are expected to block relatively
      greater portions of the virus particle surface compared to small molecule
      entry inhibitors. However, antibodies depend upon the human immune system
      responses for clearing up the virus particle. In contrast, nanoviricides
      are thought to be capable of acting as completely programmed chemical
      robots that finish their task of destroying the virus particle on their
      own.








3
            A
      nanoviricide is designed to be capable of encapsulating an active
      pharmaceutical ingredient (API) in its core, or “belly”. This is expected
      to reduce toxic effects of the API. Such encapsulating methods are
      currently being used in anti-cancer therapy and have shown reduced
      toxicity as well as increased efficacy (see http://nihroadmap.nih.gov/nanomedicine/)
      . Our goal, which we can give no assurance that we will achieve, is for
      NanoViricides, Inc. to become the premier company developing nanomedicines
      for anti-viral therapy.




6
 Table of Contents




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 may contain 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. SeePart
I,Preclinical
Safety And Efficacy Studies.





It is
important to realize that the flexible nanoviricides nanomedicines show
substantial advantages over hard sphere nanoparticles in this antiviral drug
application. Hard sphere nanomaterials such as dendritic materials (dendrimers),
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 towards US FDA
and international regulatory approvals. Our long-term research efforts are aimed
at augmenting the nanoviricides that we currently have in development with
additional therapeutic agents to produce further improved anti-viral agents in
the future.





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”) and International regulatory
agencies for these drugs. The Company 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 early stage of pre-clinical development, has significantly advanced through
the US FDA regulatory process. If and as these advances occur, the Company may
attempt to partner with more established pharmaceutical companies to advance the
various drugs through the approval process.





7
 Table of Contents





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.,
(TheraCour) 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.  In addition, TheraCour has permitted
the Company to use its nanomaterials to develop a treatment against Dengue
viruses (including Dengue Hemorrhagic Fever), Ebola/Marburg viruses, and viruses
causing certain eye diseases.





We
currently have, in early, active development, products against HIV, H5N1 and
other Highly Pathogenic Avian Influenzas (H5N, H7N, H9N HPAI, Bird Flu), common
Human Influenzas, Rabies, Dengue, , and Adnoviral Epidemic Kerato-Conjunctivitis
(EKC).  EKC is a severe pink eye disease that may lead to blurry
vision in certain patients after recovery. 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. The Company will negotiate with TheraCour to obtain licenses for
additional viral diseases as necessary.








Background: Preclinical
Safety And Efficacy Studies





The
discussions in this section and throughout this Form 10-K describe the tests
that have been conducted and the results obtained. These results do not provide
sufficient evidence regarding efficacy or safety to support an Investigational
New Drug (IND) application with the FDA. Additional studies will need to be
conducted. It must be noted that subsequent results may or may not corroborate
earlier results.





Preliminary
Safety Studies In Vitro




We have
conducted limited initial animal safety studies on one of the core TheraCour(TM)
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.





Several
additional animal studies have been conducted in which the effect of a
nanoviricide in the context of a disease was evaluated using histopathological
techniques. Mice infected with influenza virus (H1N1) in a lethality type of
study were treated with nanoviricides. The histological effects observed to date
have been mild and explained by the disease state and there do not appear to be
any deleterious effects of any significance that related to the nanoviricides
drugs.  Systematic studies for evaluating the safety or toxicity
threshold will be performed in the future.





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.





8
 Table of Contents





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 1/50th 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.





We have
also performed studies in vitro in which a murine cytomegalovirus (CMV)
preparation was subjected to dilute solutions of two different nanoviricides and
the resulting solutions were studied by electron micrography to evaluate
morphological changes in the virus. The nanoviricide treatments led to complete
loss of the virus's lipid coat, resulting in the virion capsids spilling out.
The virion capsids of CMV lack the coat proteins required for attachment to
cells and are non-infectious.  Electron micrographs depicting this can
be found on our web site at http://www.nanoviricides.com/action_small.html.





Preliminary
Efficacy Study against Common Influenza





The
preclinical animal testing, performed to study the efficacy (effectiveness) of
the test nanoviricide (anti-human influenza, H1N1) substances, revealed
potential for development as drugs for the reasons delineated below.
Several separate and distinct sets of experiments were performed to address
different questions regarding efficacy.





Certain
sets of experiments were conducted to determine the destruction/protection of
the animal organs. There were ten animals per group and positive and negative
controls were employed. Lethal infectious challenges of H1N1 influenza virus
were administered, followed by treatment with nanoviricides after a significant
delay. The active substances appeared to have protected the organs so that
there were no histological (microscopic tissue) changes to the internal
organs of the treated animals. Highly significant tissue damage was found in the
internal organs of the unprotected (no nanoviricide treatment)
groups.





Another
set of experiments was performed, again on five separate groups each containing
ten animals where the viral load was determined in the animals. The findings
revealed that the viral load (number of viral particles per cubic millimeter) in
the treated animals was significantly lower than that found in the control
animals.




These
initial animal findings suggested that the test nanoviricide compound was an
effective treatment for human influenza in mice and that the concept of using a
nanoviricide as a treatment for certain viral illnesses was a valid one and was
deserving of further study. In more scientific terms, the statistical test was
met for validity of the findings and these findings could be considered
statistically significant. Thus, in statistical terms, one could say that the
null hypothesis, that is the statistical likelihood that the observed
result was due to chance and not the effect of the drug, was
rejected.





Preliminary
Cell Culture Studies Against H5N1 Avian Influenza, Clade 1 and Clade
2





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.





Four
different nanoviricides were selected on the basis of the statistical test
called the p-value, (explained below). The p-values for these four compounds
were p<.003 which meant that there was a high statistical probability that
these results were due to the effect of the test nanoviricides and not due to
chance. Thus the "null hypothesis" is rejected and the results can be considered
statistically significant.





9
 Table of Contents





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(TM), a drug highly specific to H5N1 that is being developed against
the Vietnam strain. We currently believe that it is very likely to work against
the Indonesian strain although further studies will be required to determine its
efficacy against various highly pathogenic stains of influenza. If it fails to
work against the Indonesian 2006 strain, further development may become
necessary.





Another
nanoviricide which is based on a ligand that we designed in-house, using
rational drug design strategy, 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 “FluCide-HP(TM)”, a drug designed to be
group-specific against emergent and existing highly pathogenic influenza viruses
(including H5N1, H7N, H9N and others). Non-H5N1 HPAI (non-pathogenic avian
influenza) strains could become a pandemic threat when their occurrences
increase, 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, re-assortment or recombination events leading to failure of vaccines
and existing drugs.





A third
nanoviricide is based on a ligand that we designed for attacking all influenza A
viruses (type-level specificity). This has shown strong efficacy against H5N1 as
well, as expected. This is being developed as “FluCide-I(TM)”, a drug designed
primarily for use against serious cases of human influenza.





Preliminary
analysis of the H5N1 preclinical in vitro studies performed in Vietnam showed
that many nanoviricide(TM) 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.





All of
the above studies have been repeated with the same as well as additional test
methodologies (for example, evaluation of CPE quantitatively by a cell viability
soluble dye assay) producing confirmatory results against this rgH5N1 Vietnam
strain (based on the Vietnam 2004/2005 H5N1 strain).





Additional
cell culture studies against the wild-type clade 2 H5N1 strain isolated in
Vietnam in late 2006 showed that FluCide-HP caused a 90% reduction in CPE as
measured by the dye assay, whereas FluCide-I gave a 70% reduction in CPE,
indicating that both of these broad-spectrum drugs are highly effective even
against different strains and different clades of H5N1.





The
Indonesia 2006 H5N1 strain also belongs to the clade 2 subgroup within H5N1
subtype.





Both of
these drug candidates were also highly effective in vivo against influenza A
H1N1 strain (see below). These studies provide a preliminary indication that the
various influenza viruses may have limited ability to escape these nanoviricides
drugs via mutations and other changes.  The choice of ligands we have
performed in such a fashion that the potential for a virus strain to mutate
and escape the nanoviricide drug and still remain a serious cause of disease, is
minimized.  Further studies are planned.





Preliminary
Efficacy Studies In Vivo - Common Influenza





100% of Mice Survived LongAfter All Mice
Treated With Oseltamivir Had Died.





All but
the antibody-based anti-influenza nanoviricides have been 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 substantially more
efficacious than oseltamivir (Tamiflu(R)). Initial unpublished data suggest that
FluCide-I may be as much as 8 to 10 times (800% to 1,000%) superior to Tamiflu
in common influenza.





Additional
studies have been performed in the same highly lethal mouse model with H1N1
infection wherein all the mice treated with oseltamivir died within 151.4±1.0
hours, at which point 100% of the mice treated with a nanoviricide using an
improved sialic-acid-based ligand (improved FluCide(tm)-I) as well as 100% of
the mice treated with a nanoviricide made using a ligand designed against the
high path site of highly pathogenic influenzas including H5N1 (FluCide-HP(tm))
were still surviving. The mice treated with FluCide-HP survived until 186.0±1.4
hours, whereas those treated with FluCide-I survived until 190.0±3.7hours in this test. (The
control, untreated mice died within 119.0±0.6 hrs. Oseltamivir is the active
ingredient of Tamiflu(R)). It is estimated that the Tamiflu dose would need to
be increased by much more than ten times (i.e. much more than 1,000%) to match
the efficacy of the improved FluCide-I. These estimates are very preliminary in
nature.





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Considering
that the preclinical data for oseltamivir and for peramivir are similar in terms
of effect on survival or time course, it is clear that our nanoviricides may be
expected to be far superior to peramivir as well.





From this
unpublished data, we have concluded that the results are statistically
significant with a p<0.003.





Virus
Load in lungs of lethally infected
animals was reduced significantly.





In the
above study, the virus load in lungs of infected animals was reduced to 92±21 pfu/ml by FluCide-HP, and
119±18pfu/ml by
the improved FluCide-I in this study. These are very low levels of virus load.
The control untreated mice had a viral load of 946± 115 pfu/ml at this sampling
point.  Thus, the reduction in viral load was approximately 1 log
units for both of these candidates.  Virus load reduction estimates
depends upon various factors.  Improvement in dosing regimen may be
expected to provide a further reduction in viral load.





Preliminary
Efficacy Studies In Vivo – Rabies





As part
of our agreement with Vietnam that enabled us to perform studies on various H5N1
strains and gave us access to anti-H5N1 antibodies from multiple host species,
we have undertaken the development of anti-rabies drug candidates.





We
performed two separate animal studies using a lethal mouse model in which mice
were infected intracerebrally with 1,000LD50 of rabies challenge standard virus
strain. Each group had 10 animals and there were 36 groups all
together.  In both studies, three different nanoviricides led to
significant indefinite survival of mice. In the intracerebral
virus-neutralization mechanism study, two of the tested nanoviricides led to 30%
of the mice surviving indefinitely, and one led to 20% of the mice surviving
indefinitely. In the intraperitoneal nanoviricide administration route study,
two of these nanoviricides led to 20% of the mice surviving indefinitely. A 20%
or greater population survival is considered statistically significant in this
study. BayRab(R), a commercial antibody used for post-exposure prophylaxis of
rabies, gave 0% population survival rate in both studies. A nanoviricide made
using antibody-based ligand followed the same course as the antibody itself, and
gave a 0% population survival rate.





These
studies appears to be the first ever in which a non-vaccine agent led to a
significant population survival extent in rabies-infected mice in any high
lethality infection protocol.  Two of the three nanoviricides that led
to high population survival rates in these studies are being further developed
under RabiCide-I(tm) project.  Further studies are
planned.





On July
3, 2008, the Company signed an agreement with the Centers for Disease Control
and Prevention (CDC, Atlanta, GA) for further animal studies. If these studies
meet the goals and expectations of the CDC Rabies scientists, it is anticipated
that the Company will be able to develop an anti-rabies nanoviricide drug. The
Company anticipates that such a drug could be used for post-exposure
prophylaxis, replacing costly antibody therapies. The Company also anticipates
that additionally, a post-infection rabies treatment drug may also be possible,
if the testing results so indicate.





An
estimated 10 million people receive post-exposure treatments each year after
being exposed to rabies-suspect animals. About 30,000 people in the United
States receive both pre-and post exposure prophylaxis every year, at a cost of
over $1000 per treatment course. The annual number of deaths worldwide caused by
rabies is estimated to be 55,000, mostly in rural areas of Africa and Asia,
according to a recent World Health Organization report. The market size for
post-exposure prophylaxis for rabies has been estimated at $300 million to $500
million annually.





Rabies, a
uniformly fatal disease found primarily in Africa and Southeast Asia, had never
before been successfully treated with drugs. There are currently no FDA-approved
treatment options for rabies once symptoms develop. In addition, the Company
believes that significantly increased survival rate of these lethally infected
animals is possible in the dose-ranging studies to follow.





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Preliminary
Efficacy Studies In Vivo – Viral EKC





Viral
EKC, or Viral Epidemic Kerato-Conjunctivitis is a severe pink eye disease that
lasts for several days with painful discharge causing sticky eyes. In addition,
a few percentage of the recovered patients experience permanent blurred vision
or partial loss of vision due to the presence of “immuno-precipitates” that
occur as a result of the body’s immune response to the virus. Approximately 50%
of all EKC cases are viral; the remaining being caused by bacteria. Bacterial
EKC is treatable with antibiotics. There are no current treatments against Viral
EKC (“EKC” for short, in this document).





In a
preliminary rabbit eye animal study, we tested two different nanoviricides
against EKC caused by infection with Adenovirus 5, a well known causative agent.
The virus was supplied by the CDC. Controls of uninfected, untreated eyes, of
infected, untreated eyes, and of infected eyes treated with the standard eye
wash formulating solution, were also part of the experiment. Treatment with eye
drops of nanoviricides was started 15 hours post-infection, well after the
disease had set in, and was continued twice a day for ten days. On the third
day, eyes treated with a nanoviricide B were completely cleared up with no
redness, stickiness, exudate, or furry eyebrows. The other nanoviricide was
slightly less effective. The eyes in control groups in contrast showed all
classic signs of infection throughout the due course of disease. Further
examination has indicated that treatment with nanoviricide B resulted in all
eyes being completely free of sub-epithelial filtrate and immuno-precipitate
formation, whereas eyes in the control groups exhibited SEI and
immuno-precipitates as expected. Further results regarding viral load and other
effects are being evaluated.





The study
concluded that both nanoviricide B and nanoviricide C were highly effective
against adenoviral EKC and of these, nanoviricide B was substantially superior.
Further studies are scheduled.





In
addition to adenoviruses, herpesviruses form another important cause of viral
EKC as well as additional related diseases of the eye. We plan to extend our
studies to herpesviral eye infections in the near future.





The
Company is in contact with several major pharmaceutical companies for
development collaboration for viral EKC drugs.








Preliminary
Efficacy Studies In Vivo – HIV





In a
preliminary animal study against HIV in a well established animal model, SCID-hu
Thy/Liv mice, we tested a number of nanoviricides against a positive control
(that is known effective drug) that comprised the clinically employed well
established HAART therapy of oral three drug combo (AZT+3TC (lamivudine)
+Crixivan (indinavir sulfate)). Survival data as well as viral load reduction
data from this lethal challenge preliminary study indicated that at least one
nanoviricide drug candidate was significantly superior to the oral cocktail.
Several additional parameters were tested and indicate significant benefit of
nanoviricide therapy. The data have not been fully analyzed as of this
writing.





Based on
this study, the Company believes that it has a strong lead drug candidate
against HIV. If the preliminary results are substantiated in further studies,
and later in human clinical trials, it would be the first time ever that a new
drug in development would have been found to be superior to the entire cocktail
of three drugs called HAART.





At
present, there are several drugs against HIV. These have led to HIV becoming a
chronic, treatable, disease, that can be controlled through the lifespan of an
infected individual until an episode occurs. An episode is usually characterized
by development of resistance against the therapy given. Drugs in the cocktail
are then substituted or additional drugs added to provide additional
benefit.





To the
initially developed three drug classes, NRTI, NNRTI, and PI, recently three new
classes have been added. These are EFI (Entry/Fusion Inhibitors) such as
Fuzeon((TM), Roche), II (Integrase Inhibitors) such as Isentress (tm, Merck),
elvitegravir (Gilead), and most recently, CCR5-blockers, maraviroc (Pfizer). Of
these, NRTI, NNRTI, PI, and II act intracellularly, blocking different steps in
the virus replication. EFI block the early step of virus entry and fusion with a
human cell. CCR-5 blockers inhibit viral entry by blocking one of the receptors
on the human cells used by the virus. However, HIV can also use CXCR4 in
addition to or instead of CCR5, and viruses that do so cannot be affected by
CCR5-blockers. Current standard of care is a three-drug combination called
HAART. This leads to significant viral load control until resistance emerges. A
recent clinical trial has established the validity of an approach that combines
an II as a fourth drug into the original three drug combination cocktail. Fuzeon
showed significant toxicity, potentially due to its action against human cells,
and has not gained much acceptance, with substantial number of patients falling
off therapy due to side effects.





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None of
these drug classes alone cause benefits equivalent to the combination of three
drugs of the HAART cocktail. Nanoviricides are expected to act by a completely
novel mechanism that is expected to result in complete dismantling of the
extracellular virus load, rather than simply inhibition of entry of a small
fraction of the extracellular virus load.  Thus, nanoviricides
mechanism is distinct from and superior to that of EFI and CCR5-blockers, as
well as antibody cocktails. In addition, nanoviricides can be combined for
significant geometric increase in benefit with agents that act intracellularly
such as the NRTI, NNRTI, PI and II class of drugs. Thus we believe that
nanoviricides will become a significant tool in the arsenal against
HIV.





If the
viral load reduction seen in the preliminary animal study by a nanoviricide in
comparison with HAART therapy proves to be predictive of benefit, then we can
estimate that the anti-HIV nanoviricide alone or perhaps in combination with one
or more components of the existing arsenal of drugs may provide what has been
called a “functional cure” against HIV. A total cure is a state in which all
virus, including copies of its genome integrated into human cells, is eliminated
from the body, so that the virus infection does not exist and cannot recur. A
functional cure, as defined by Dr. Anthony Fauci of NIAID, can be paraphrased as
a drug treatment which practically eliminates substantially all circulating
virus, so that therapy can be stopped until a new recurrent occurs after a
significantly prolonged time interval. Thus, patients can live worry-free lives
for years before requiring treatment again.





A
Note on Our Studies to Date





Current
pharmaceutical industry work in antiviral therapy generally results in small
efficacy improvements. Thus, in the case of influenza, peramivir(TM), (BioCryst)
was reported as having approximately equal efficacy to oseltamivir (Tamiflu,
Roche). However, it was suggested that peramivir(TM) may have a superior safety
profile and thus may enable use of large doses (compared to Tamiflu). Peramivir
recently failed its Phase II clinical trials, and BioCryst stated that this may
have been due to the use of needles of insufficient length in the Phase II
study.





These
levels of efficacy differences between other product candidates against
influenzas and bird flu can be easily seen to be insignificantly small compared
to the ones established in our preliminary studies for the nanoviricides
tested.





However,
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 development 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 drugs
suitable for commercial production.





It must
be stressed that the results discussed above 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.




In
statistics, a result is called significant if it is unlikely to have occurred by
chance. "A statistically significant difference" simply means there is
statistical evidence that there is a difference; it does not mean the difference
is necessarily large, important or significant in the usual sense of the
word.





In
traditional frequentist statistical hypothesis testing, the significance level
of a test is the maximum probability, assuming the null hypothesis, that the
statistic would be observed. Hence, the significance level is the probability
that the null hypothesis will be rejected in error when it is true (a decision
known as a Type I error).  The significance of a result is also called its
p-value; the smaller the p-value, the more significant the result is said to
be.





Significance
is represented by
the Greek symbol, α(alpha). Popular levels
of significance are 5%, 1% and 0.1%. If a test of significance gives a p-value
lower than the α-level, the null
hypothesis is rejected. Such results are informally referred to as
'statisticallysignificant'.
For example, if someone argues that "there's only one chance in a thousand this
could have happened by coincidence," they are implying a 0.1% level of
statistical significance. The lower the significance level, the stronger the
evidence.





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Avery small
α-level (say 1%) is less likely to be more extreme than the critical value and
so is more significant than high α-level values (say 5%). However, smaller
α-levels run greater risks of failing to reject a false null hypothesis (a Type
II error), and so have less statistical power. The selection of an α-level
inevitably involves a compromise between significance and power, and
consequently between the Type I error and the Type II error.





Our
experiments have constantly resulted in the p value less than 0.003, which makes
the tests very accurate, that there are no errors statistically for such an
experiment, and all the values obtained from these experiments are of
significance.





Mechanism
of Nanoviricides Action





It should
be noted that while the nanomaterials and nanomedicines we are developing are
designed with the  set of ground rules stated earlier as our design
goals, 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, or a group of viruses.





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. Both high efficacy and low efficacy
ligands can be combined on the same nanomicelle for “tuning” the spectrum of
activity of the nanoviricide drug.





A
Note on US FDA Priority Review Vouchers


The Food
and Drug Administration Amendments Act of September 2007 authorizes the FDA to
award a priority review voucher to any company that the FDA has determined is
eligible for priority approval process for a treatment for a neglected tropical
disease.  The priority review voucher can be traded to another company
in a manner similar to carbon (emissions) credit vouchers. The recipient company
can save as much as six months on their drug review process, and it is
anticipated that they would be willing to trade in vouchers with cash benefits
to the company developing drugs against neglected tropical diseases. The
regulation became effective as of September 30, 2008.





Economists
at Duke University, who proposed the voucher concept in 2006, have
calculated that reduction of the FDA approval time from 18 to six months could
be worth more than $300 million to a company with a top-selling drug with a net
present value close to $3 billion. At this level, the voucher would be expected
to offset the substantial investment and risk required for discovery and
development of a new treatment for a neglected tropical disease. (David B.
Ridley, Henry G. Grabowski and Jeffrey L. Moe, "Developing Drugs For Developing
Countries", Health Affairs, 25, no. 2 (2006): 313-324; doi:
10.1377/hlthaff.25.2.313; (C) 2006 by Project Hope. and  http://blogs.cgdev.org/globalhealth/2007/10/fda_priority_review.php)





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While it
is too early to say whether NanoViricides, Inc. can obtain priority review for
its drugs against neglected tropical diseases, the high efficacies of our drug
candidates lead us to believe that this may be possible. FDA awards priority
review status on the basis of several criteria. NanoViricides, Inc. is currently
working on several neglected tropical diseases, including Dengue fever viruses,
rabies, Ebola/Marburg viruses, among others. Of these, Dengue viruses are
explicitly included in the list under this Public Law, and the remaining viruses
are eligible for similar treatment according to the language in the Public Law,
at the discretion of the Secretary of Health (Foodand Drug
Administration  Amendments Act of 2007, P.L. 110–85, Sept. 27, 2007,
http://www.fda.gov/oc/initiatives/fdaaa/PL110-85.pdf).








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; all work performed
by KARD must have prior approval by the executive officers of NanoViricides; and
we retain all intellectual property resulting from the services by
KARD.





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(TM)-I, AviFluCide-I(TM) and FluCide-HP(TM) against various H5N1 strains
in cell culture were successfully performed at the laboratories of the National
Institute of Hygiene and Epidemiology in Hanoi (NIHE). In additionally, animal
studies of RabiCide drug candidates were also performed at the NIHE BSL2
facilities. The next stage of the project, animal testing of the Influenza and
H5N1 candidates, has been delayed until the BSL3+ animal facility in Hanoi is
ready. The H5N1 testing will utilize the NIHE’s BSL3 (biological safety
laboratory level 3) laboratory. Rabies testing can safely be done at their BSL2
facility.





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.





On April
4, 2007, the Company signed a Cooperative Research and Development Agreement
(CRADA) with the Walter Reed Army Institute for Research (WRAIR) for a
cooperative research project to test the effectiveness of the Company’s products
against the Dengue Fever Viruses.





15
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On
October 4, 2007, the Company signed a Material Transfer Agreement (MTA) with the
United States Army Medical Research Institute of Infectious Diseases (USAMRIID)
for a cooperative research project to test the effectiveness of the Company’s
products against the Ebola and Marburg Viruses.





On
February 4, 2008, the Company signed a Cooperative Research Agreement with the
United Stated Armed Forces Institute of Pathology (USAFIP) to test the efficacy
of the Company’s nanomedicine technology in preliminary animal studies against
H5N1 and HIV viruses. The company will fund such studies in the amount of
$122,844.





On July
3, 2008, the Company signed a Materials Cooperative Research and Development
Agreement (M-CRADA) with the Centers for Disease Control and Prevention (CDC)
for testing anti-rabies nanoviricides. The testing is expected to begin late in
the third quarter of 2008.





In
addition, the Company has received several cooperative research and development
agreements (CRADA's) from different government agencies, civilian as well as
military. These CRADA's are currently in review by the Company counsel. We have
also received requests for material for testing under Material Testing
Agreements (MTAs) from certain agencies. However, there can be no assurance
that a final agreement may be forthcoming.





In
addition, the Company has had preliminary negotiations and discussions with
other pharma and non-pharma commercial enterprises regarding commercial projects
based on the Company’s technologies.  The Company has signed or has in
legal review Non-Disclosure Agreements with certain major Pharmaceutical
Companies. The Company also has in legal review stage certain Materials Transfer
and Testing Agreements with certain major Pharmaceutical companies. However,
there is no assurance that the Company may enter into such agreements with these
or other Pharmaceutical companies, nor is there any assurance that any of these
agreements and subsequent research, testing, and evaluation, may result in any
collaborations or partnerships with these or other pharmaceutical
companies.








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 is expected to have the potential to allow us to
expeditiously develop a new drug to fight new and emerging threats. The Company
has shown this in multiple presentations to various agencies within 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. Last year, a 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. This year,
there have been cases of an unidentified infection in children in Northern India
that resulted in several deaths.





Background:
Anti-HIV Drugs





Importance
of Reduction in Viremia





16
 Table of Contents





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 is 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
circulatingvirions 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








As
previously anticipated, we began pre-clinical studies of our first generation
anti-HIV nanoviricide drug, HIVCide(tm)-I in the later part of our 2007 fiscal
year. The early studies have been extremely successful, and in these preliminary
studies we have found at least one lead drug candidate that provided results
superior to the three-drug oral cocktail that is currently in human clinical use
as HAART therapy. We plan on continuing these studies towards the preparation of
a Tox Package for filing an IND in the near future. These planned studies are
elaborate, intensive, time-consuming, resource-intensive, and expensive. Our
ability to conduct these studies depends upon adequate financing for the staff
as well as for the materials required for the various experiments. We plan on
continuing to rely upon external providers and collaborators for various
services as before, wherever possible, in order to minimize capital expenses.
The Company will strategically evaluate any outsourcing of the production of
certain key intellectual property sensitive materials very
carefully.





As the
studies progress, we may find it necessary to accelerate the development of a
second anti-HIV drug, HIVCide-II, in order to cover the various types, strains,
quasi-species and mutants of the HIV viruses as completely as possible. Our
objective is to develop anti-HIV drugs that together respond to the needs of
combating the rapidly changing HIV viruses in the most complete fashion
possible. The Company expects that these two anti-HIV drugs together should
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.





17
 Table of Contents





Together,
these two drugs in combination with one or more of the existing therapies may
result in a "functional cure" for HIV infection. To obtain a complete cure, it
will be necessary to eliminate the HIV virus and its genome completely from the
body. Eliminating the HIV virus completely would require eliminating it from the
"memory cells" - dormant cells inside which the HIV genome remains hidden, and
springs to life in a later episode. The current two nanoviricides are not
designed to accomplish this task. The Company is currently researching various
approaches for impacting the HIV-hiding memory cell population in our march
towards a true cure for HIV. However, we are fully aware that curing HIV will be
a very long process.








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(TM)
and rimantadine(TM) 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 to those drugs.





18
 Table of Contents





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 (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. Peramivir recently failed its Phase II human
trials, and BioCryst has stated that this may be due to the use of short needles
in the Phase II study.





Several
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. The New England Journal of
Medicine reported one study which assessed the results of 17 prior studies
related to the the effectiveness of neuraminidase inhibitors. de Jong, Memo d.,
Thanh, Trran T., Khanh, Truong H., et. al. “Oseltamivir
Resistance during treatment of Influenza A (H5N1) Infection, New England Journal of
Medicine, Volume 353:2667-2672, December 22, 2005, November
25.





Antibodies
Against Influenza


Crucell,
NV has recently reported that they are developing monoclonal antibodies as drugs
against H5N1 bird flu.


We have
ourselves are developing AviFluCide-I which uses a ligand based on certain
anti-H5N1 antibodies. However, escape of virus against antibody drugs has been a
major challenge, particularly for the influenzas and for HIV, and many other
viral diseases. All of these viruses exhibit a significant antigenic drift,
caused usually by small changes in the structure of their coat
protein.





Our
broad-spectrum nanoviricides, FluCide-I and FluCide-HP, are expected to be able
to attack the virus even when it mutates, and thereby suppress escape
significantly. However, this needs to be proven in extensive
studies.





1
            The
      Writing Committee of the World Health Organization (WHO) Consultation on
      Human Influenza A/H5. Avian influenza A (H5N1) infection in humans. N Engl
      J Med 2005;353:1374-1385.





19
 Table of Contents




2
            Hien
      TT, Liem NT, Dung NT, et al. Avian influenza A (H5N1) in 10 patients in
      Vietnam. N Engl J Med
2004;350:1179-1188.




3
            Chotpitayasunondh
      T, Ungchusak K, Hanshaoworakul W, et al. Human disease from influenza A
      (H5N1), Thailand, 2004. Emerg Infect Dis
  2005;11:201-209.




4
            Moscona
      A. Neuraminidase inhibitors for influenza. N Engl J Med
      2005;353:1363-1373.




5
            Identification
      of influenza isolates by hemagglutination inhibition. In: Department of
      Communicable Disease Surveillance and Response. WHO manual on animal
      influenza diagnosis and surveillance. Geneva: World Health Organization,
      2002:28-36.
(WHO/CDS/CSR/NCS/2002.5.)




6
            de
      Jong MD, Cam BV, Qui PT, et al. Fatal avian influenza A (H5N1) in a child
      presenting with diarrhea followed by coma. N Engl J Med
      2005;352:686-691.




7
            Boom
      R, Sol C, Beld M, Weel J, Goudsmit J, Wertheim-van Dillen P. Improved
      silica-guanidiniumthiocyanate DNA isolation procedure based on selective
      binding of bovine alpha-casein to silica particles. J Clin Microbiol
      1999;37:615-619.




8
            Boom
      R, Sol CJ, Salimans MM, Jansen CL, Wertheim-van Dillen PM, van der Noordaa
      J. Rapid and simple method for purification of nucleic acids. J Clin
      Microbiol 1990;28:495-503.




9
            Chen
      H, Smith GJ, Zhang SY, et al. Avian flu: H5N1 virus outbreak in migratory
      waterfowl. Nature 2005;436:191-192.




10
            Gubareva
      LV, Kaiser L, Matrosovich MN, Soo-Hoo Y, Hayden FG. Selection of influenza
      virus mutants in experimentally infected volunteers treated with
      oseltamivir. J Infect Dis
2001;183:523-531.




11
            Le
      QM, Kiso M, Someya K, et al. Avian flu: isolation of drug-resistant H5N1
      virus. Nature 2005;437:1108-1108.




12
            Whitley
      RJ, Hayden FG, Reisinger KS, et al. Oral oseltamivir treatment of
      influenza in children. Pediatr Infect Dis J 2001;20:127-133. [Erratum,
      Pediatr Infect Dis J 2001;20:421.]




13
            Kiso
      M, Mitamura K, Sakai-Tagawa Y, et al. Resistant influenza A viruses in
      children treated with oseltamivir: descriptive study. Lancet
      2004;364:759-765.




14
            Ward
      P, Small I, Smith J, Suter P, Dutkowski R. Oseltamivir (Tamiflu) and its
      potential for use in the event of an influenza pandemic. J Antimicrob
      Chemother 2005;55:Suppl 1:i5-i21.





20
 Table of Contents




15
            Yen
      HL, Monto AS, Webster RG, Govorkova EA. Virulence may determine the
      necessary duration and dosage of oseltamivir treatment for highly
      pathogenic A/Vietnam/1203/04 influenza virus in mice. J Infect Dis
      2005;192:665-672.




16
            Maines
      TR, Lu XH, Erb SM, et al. Avian influenza (H5N1) viruses isolated from
      humans in Asia in 2004 exhibit increased virulence in mammals. J Virol
      2005;79:11788-11800.








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 were tested at NIHE, Vietnam, in the first quarter of
2007. The Rabies drug, identified as RabiCide(TM), salvaged 30% of the animals
given 1000X the lethal dose of rabies virus directly into the brain. There can
be no assurance that our drug candidate (RabiCide), if developed, can
successfully be manufactured. There are no guarantees that the drug, even if
successfully manufactured, can produce revenue for the Company.





The
United States Center for Disease Control has recently declared that the
United States is now free of canine rabies, although dogs and humans may still
get rabies from other animals such as bats, raccoons, and skunks
(http://cdc.gov/news/2007/09/canine_rabies.html).In addition,the World Health
Organization has recently declared that the world will be free of canine rabies
by the middle of the next decade. Thus the commercial potential, for the
Company,  of a rabies drug is uncertain.








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 these 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 may
not be necessary to overcome this challenge in order to develop good
nanoviricides against Dengue fever, West Nile virus, and other diseases that
progress only slowly to attack the CNS. There may well be 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 in such
diseases.  Blood-brain barrier is also compromised in severe disease
states. This may help the nanoviricides to be effective against neurotropic
viruses even after they have localized in the CNS. Extensive studies will be
necessary to resolve blood-brain-barrier issues. Alternatively, it is possible
to inject drugs directly into the CNS, although this is a cumbersome and
skill-requiring procedure.





21
 Table of Contents





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 recently initiated
discussions with various civilian and military agencies as well as with various
universities and commercial entities regarding various
collaborations.





Products





NanoViricides, Inc.
currently has no products for sale.





Products
In Development





The
following table summarizes NanoViricides active development projects as of June
30, 2008.





Virus
                      Development
      StageInfluenza
      (Common)
                      PreclinicalAvian
      Flu (H5N1)
                      PreclinicalAvian
      Flu-Highly Pathogenic
                      PreclinicalRabies
                      PreclinicalHIV/AIDS
                      PreclinicalEKC
                      PreclinicalDengue
                      Early
      R&DHCV
                      R&D
      to begin in
2009








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. One mechanism
involves the hemagglutinin coat protein of influenza virus binding to sialic
acids on cell surfaces.  Our broad-spectrum ligand used in FluCide-I
is based on the sialic acid expressed by cells. Therefore, it is expected to
work well against all of the influenza viruses.  Since all influenza
viruses, no matter what type (A, B, C), which subtype (e.g. HxNy of Influenza
A), or clades, or strains, must bind to one of two varieties of sialic acid, we
have designed the ligand such that all of the influenza viruses must bind to our
ligand.   If an influenza virus escapes FluCide-I, this mutant
virus would be unable to bind to both types of sialic acids, and would be thus
unable to infect most animal species, including birds and
mammals.





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 currently planned for the fourth quarter of 2008,
based on changes in availability of BSL3+ animal facility in
Vietnam.  However, If we can improve the efficacy of FluCide-HP
further, it will be unnecessary to develop a specific drug just for
H5N1.





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 far 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.





22
 Table of Contents





RabiCide-I, a nanoviricide
against Rabies finished its first set of animal studies in the first quarter of
2007 in Vietnam. The candidate ligands for this nanoviricide were designed by
the Company using publicly available information regarding the interaction of
the rabies virus with cells. Additional animal studies at CDC are expected to be
performed during the fourth quarter of 2008 or early in 2009.





HivCide-I, This is our first
announced drug project against HIV-I. Because of the world-wide concern about a
possible H5N1 pandemic, we had moved HivCide-I development back. We have now
resumed development of this drug. Our first HIV drug to be developed is a
targeted nanoviricide against HIV  and is engineered with specific
recognition ligands that allow multiple point binding to inactivate HIV virus in
the bloodstream.





HivCide-II will be a targeted
nanoviricide against HIV strains that are not attacked by HivCide-I, and will
have the same mechanism of action as HivCide-I, except that it will possess a
different ligand that specifies attacking a different subset of virus strains,
types, and subtypes than HivCide-I.





EKCCide(TM)-I- We undertook a new
project this year and have already designed a ligand, made a nanoviricide
drug,  and completed successful animal studies that indicate
significant preliminary efficacy and safety of a drug candidate against the
severe pink eye disease caused by adenoviruses called epidemic
kerato-conjunctivitis. .





HCV-AHepatitis
C nanoviricide is planned for research and development to begin in 2009. The
Company has not yet sourced the materials to target this disease. The Company
has only begun the early stages of a plan to develop nanoviricides against
Hepatitis C.





All of
these drugs except EKCCide are being developed as injectables, EKCCide is an
ophthalmic formulation or eye drops solution.





It is
possible to administer nanoviricides drugs using other approaches as well. 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
the 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, as soon as appropriate
facilities and finances are available. The Company believes that our
anti-influenza drug candidates, anti-HIV drug candidates, as well as anti-EKC
drug candidates have all produced substantial positive results and should be
developed further towards the goal of filing appropriate IND
applications.  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. The
Company has received significant interest from certain major Pharmaceutical
companies for potential licensing or co-development of some of our drug
candidates. However, none of these distributor or co-development agreements is
in place at the current time.





23
 Table of Contents





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 FluCide-I, FluCide-HP, AviFluCide-I, HIVCide-I,
EKCCIde-I, 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.





Certain
changes in FDA regulations have enabled the use of research products produced in
a non-GMP-certified facility for certain human studies, provided the materials
and production facility meet certain standards. The Company may be able to take
advantage of these regulatory amendments in order to advance our drugs into IND
stage and first-in-human studies more rapidly.





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 the following 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 additional viruses.





24
 Table of Contents





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
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 $ 2,086,979 since
inception through June 30, 2008 and $746,309 and $617,007 for the years ended
June 30, 2008 and 2007, respectively. No royalties are due or have been paid
from inception through June 30, 2008.





TheraCour
Pharma, Inc. owns 35,370,000 shares of the Company’s 119,270,677 outstanding
shares of common stock as of June 30, 2008. Anil Diwan, the Company’s President
and Chairman of the Board and Director, owns approximately seventy percent (70%)
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, HivCide-I and II, EKCCide, and others, may be eligible for patent
protection. The Company plans on filing patent applications for protecting these
drugs when we have definitive results from either in-vitro or in-vivo studies
that can be replicated by others.





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
      CompanyPatent
      or Application
                      Date
      of Issue/
                        Application
                      US
      Expiry
                        Date
                      International
                      OwnersUS6,521,736
                        
                        (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, 2006 PCT Application.
                      Jan
      18, 2023 (estimated)
                      Applications
      to be filed.
                      TheraCour
      Pharma, Inc. [Exclusive License].PCT/US2007/001607
                        SELF-ASSEMBLING
      AMPHIPHILIC POLYMERS AS ANTIVIRAL AGENTS
                      Applied:
                        Jan
      22, 2007
                      Jan
      21, 2024 (estimated)
                      Applications
      to be filed.
                      TheraCour
      Pharma, Inc. [Exclusive
License].




25
 Table of Contents





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. The Company believes
that this patent describes an inferior technology compared to the technology in
the later patent filings of Dr. Diwan. 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 applications, no.
PCT/US06/01820, and no PCT/US2007/001607 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.




The
Company controls the research and work TheraCour performs on its behalf and no
costs may be incurred without the prior authorization or approval of the
Company.





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 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.




26
 Table of Contents





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:





£
            efficacy;


£
            safety;








£
            tolerability;


£
            acceptance
      by doctors;








£
            patent
      compliance;


£
            patent
      protection;








£
            ease
      of use;


£
            price;








£
            insurance
      and other reimbursement coverage;


£
            distribution;








£
            marketing;
      and


£
            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. has developed injectable formulations of
peramivir, an influenza neuraminidase inhibitor, for the treatment of influenza,
which recently failed in phase II clinical trials.





There are
a growing number of anti-HIV drugs being sold or are in advanced stages of
clinical development. Companies with HCV and HIV products include Gilead,
Bristol-Myers Squibb Company (BMS), Roche, Boehringer Ingelheim, Merck &
Co., Inc. (Merck), in addition to several other pharmaceutical and biotechnology
firms.





There are
currently no approved drugs for the treatment of viral EKC. A drug in
development, called CTC-96, was shown to have little clinical benefit in
published animal studies. Another drug in development, an Aganocide(tm) compound
from NovaBay Pharma in collaboration with Alcon is in Phase II clinical studies.
Aganocides, by virtue of their chemical structure, are generally not expected to
be useful for any applications other than topical.





Our HCV
drugs are at the earliest stage of development. There are a growing number of
anti-HCV drugs being sold or are in advanced stages of clinical development.
Companies with HCV products or drugs in development include Valeant, Schering,
Pharmassett, Vertex, Intermune, and Achillion, among others.





27
 Table of Contents





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, the FDA has approved other nano-particulate drugs including
Emend(R) by Merck and Rapamune(R) 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:





sPhase 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.





sPhase 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.





sPhase 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.





28
 Table of Contents





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
and Service Providers





As of
June 30, 2008, the Company had three full time employees. In addition, most of
the business activities of the Company including accounting and legal work and
business development are provided by subcontractors and consultants. Further,
the Company has subcontracted nanomaterials research and development
(“R&D”) to TheraCour.  The Company has subcontracted some of its
animal studies to KARD Scientific to date. Some of the Company's R&D work
was performed by agencies in Vietnam. In the future, the Company anticipates
having additional service providers. We believe that we have good relations with
our employees and subcontractors.





Reports
to Security Holders





As a
result of its filing of Form 10-SB/A and listing on the NASD OTC Bulletin Board,
the Company has 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-K, with audited financial
statements, unaudited quarterly reports on Form 10-Q 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-K.





29
 Table of Contents





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 currently located at 135 Wood St. West
Haven, Connecticut 06516 and our telephone number is (203)
937-6137.








ITEM 1A.    RISK FACTORS


Our
business, financial condition, operating results and prospects are subject to
the following risks. Additional risks and uncertainties not presently
foreseeable to us may also impair our business operations. If any of the
following risks actually occurs, our business, financial condition or operating
results could be materially adversely affected. In such case, the trading price
of our common stock could decline, and our stockholders may lose all or part
of


their
investment in the shares of our common stock.





This
Form-10K 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.








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:





£
            demonstration
      and proof of principle in pre-clinical trials that a nanoviricide is safe
      and effective;





£
            successful
      development of our first product candidates FluCide, AviFluCide, FluCide
      HP, and RabiCide ;





£
            our
      ability to seek and obtain regulatory approvals, including with respect to
      the indications we are seeking;





£
            the
      successful commercialization of our product candidates;
  and





£
            market
      acceptance of our products.








All of
our existing product candidates are in early stages of development. It will be
several years, if ever, until we have a commercial drug product available for
resale. 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:





30
 Table of Contents




–
            the
      absence of an operating history;


–
            the
      lack of commercialized products;








–
            insufficient
      capital;


–
            expected
      substantial and continual losses for the foreseeable
    future;








–
            limited
      experience in dealing with regulatory
issues;


–
            the
      lack of manufacturing experience and limited marketing
      experience;








–
            an
      expected reliance on third parties for the development and
      commercialization of our proposed
products;


–
            a
      competitive environment characterized by numerous, well-established and
      well capitalized competitors; and








–
            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:





–
            our
      ability to develop drugs, obtain approval for such drugs, and if approved,
      to successfully commercialize our nanoviricide
  drug;





–
            our
      R&D efforts, including the timing and cost of clinical trials;
      and





–
            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 opinion, and we have incurred significant operating losses and may not
be profitable in the future, if ever.





As of
June 30, 2008 we have a cash and cash equivalent balance of $816,386 which can
support operations through January 1, 2009, but not through our fiscal year end
of June 30, 2009. Also, the Company has incurred significant operating losses
since its inception, resulting in an accumulated deficit of $ 9,207,737 at June
30, 2008. Such losses are expected to continue for the foreseeable future.
On August 22, 2008, the Company had received and accepted subscriptions in
the aggregate amount of $3,286,000 through the offering of shares of the
Company's common stock and $106,250 through the exercise of existing warrants to
purchase stock.





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
opinion in its report which is included elsewhere in this Form 10-K. In many
cases a going concern opinion makes raising capital more difficult and often
results in terms less favorable than if the Company did not have a going
concern opinion. Therefore it is likely the going concern opinion by our
independent registered public accounting firm will affect 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.





31
 Table of Contents





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 June 30, 2008 we have a
cash and cash equivalent balance of $816,386which can
support operations through January 1, 2009, but will not be sufficient to fund
our operations for the next twelve months. We expect to incur costs of
approximately $3-5 million dollars in the upcoming twelve months to operate our
business in accordance with our business plans. On August 22, 2008, the
Company had received and accepted subscriptions in the aggregate amount of
$3,286,000 through the offering of shares of the Company's common stock and
$106,250 through the conversion of existing warrants to stock. . The $3,286,000
private placement of stock included 150,000 shares of Common Stock and 75,000
Warrants transferred in consideration of $150,000 of scientific testing and
other laboratory work performed for the Company.





As a
result of the above sale of the Company’s stock and Warrants conversion, the
Company has reserves in excess of $3,000,000.  This should permit us
to continue our operations and research and development for the next twelve
months,,but not to fully execute the first phase of the the Company’s business
plan.  In the event that we cannot obtain acceptable financing, or
that we are unable tosecure additional finacing on acceptable terms, we would be
unable to complete development of our various drug candidates. This would
necessitate implementing staff reductions and operational adjustments that would
include reductions in the following business areas:





£
            research
      and development programs;


£
            preclinical
      studies and clinical trials; material characterization studies, regulatory
      processes;








£
            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:





£
            progress,
      timing and scope of our research and development
  programs;


£
            progress,
      timing and scope of our preclinical studies and clinical
      trials;








£
            time
      and cost necessary to obtain regulatory
  approvals;


£
            time
      and cost necessary to establish our own marketing capabilities or to seek
      marketing partners;








£
            time
      and cost necessary to respond to technological and market
      developments;


£
            changes
      made or new developments in our existing collaborative, licensing
      and








£
            other
      commercial relationships; and


£
            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:





£
            enter
      into leases for new facilities and capital
  equipment;


£
            enter
      into additional licenses and collaborative agreements;
  and








£
            incur
      additional expenses associated with being a public
  company.





32
 Table of Contents




We
have limited experience in drug development and may not be able to successfully
develop any drugs.





Until the
formation of NanoViricide, Inc. (the Company's predecessor prior to the
exchange) our management and key personnel had no experience in pharmaceutical
drug development and, consequently, 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:





–
            develop
      products internally or obtain rights to them from others on favorable
      terms;


–
            complete
      laboratory testing and human
studies;








–
            obtain
      and maintain necessary intellectual property rights to our
      products;


–
            successfully
      complete regulatory review to obtain requisite governmental agency
      approvals








–
            enter
      into arrangements with third parties to manufacture our products on our
      behalf; and


–
            enter
      into arrangements with third parties to provide sales and marketing
      functions.








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:





£
            are
      found to be unsafe or ineffective in clinical
  trials;


£
            do
      not receive necessary approval from the FDA or foreign regulatory
      agencies;








£
            fail
      to conform to a changing standard of care for the diseases they seek to
      treat; or


£
            are
      less effective or more expensive than current or alternative treatment
      methods.




33
 Table of Contents





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:





£
            The
      FDA or foreign regulators may interpret data from pre-clinical testing and
      clinical trials in different ways than we interpret
  them.


£
            If
      regulatory approval of a product is granted, the approval may be limited
      to specific indications or limited with respect to its distribution. In
      addition, many foreign countries control pricing and coverage under their
      respective national social security
systems.








£
            The
      FDA or foreign regulators may not approve our manufacturing processes or
      manufacturing facilities.


£
            The
      FDA or foreign regulators may change their approval policies or adopt new
      regulations.





34
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£
            Even
      if regulatory approval for any product is obtained, the marketing license
      will be subject to continual review, and newly discovered or developed
      safety or effectiveness data may result in suspension or revocation of the
      marketing license.


£
            If
      regulatory approval of the product candidate is granted, the marketing of
      that product would be subject to adverse event reporting requirements and
      a general prohibition against promoting products for unapproved or
      “off-label” uses.








£
            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.


£
            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 2008-2009 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.





35
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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 $ 2,701,897 on research and development from inception through June 30,
2008.





We have
an R&D budget, including other allocated costs, of $2,000,000
for the next 12 months. In the last three years we have established lead
compounds against a number of viral diseases and completed proof of principle
studies against a number of viral diseases. We now have lead drug compounds
against common Influenza, High Path Influenzas (Bird Flu), HIV, and EKC. We are
currently working on identifying and establishing collaborations with major
pharmaceutical companies as well as government institutions for the purpose of
co-development of these products. Not withstanding these efforts, we will
continue the development of these drugs, as well as our other drug development
endeavors that include Rabies, Dengue viruses, and Ebola.Marburg
viruses.





The
Company has the cash on hand to complete the budgeted R&D work through June
30, 2009. Should the pre-clinical clinical studies of our HIV, Influenza,
Influenza-HP, and EKC rabies drugs meet managements expectations the Company
will require substantial additional funding to take any one or more of these
drugs into IND filing(s) with the FDA. The Company projects it will need as
additional $5 million 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 required for filing an
IND.





The
Company will be unable to proceed with its planned R&D beyond the June 30,
2009, year end without obtaining additional financing of approximately
$7,000,000.




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:





£
            the
      number and outcome of clinical studies we are planning to conduct; for
      example, our R&D expenses may increase based on the number of
      late-stage clinical studies that we may be required to
      conduct;


£
            the
      number of drugs entering into pre-clinical development from research; for
      example, there is no guarantee that internal research efforts will succeed
      in generating sufficient data for us to make a positive development
      decision;








£
            licensing
      activities, including the timing and amount of related development funding
      or milestone payments; for example, we may enter into agreements requiring
      us to pay a significant up-front fee for the purchase of in-process
      R&D that we may record as R&D
expense.







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.





36
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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.





37
 Table of Contents





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.





38
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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, Walter Reed Army Institute of
Research (WRAIR) 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 WRAIR 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 and
WRAIR is filed as an Exhibit to this 10K).





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 the permits 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.





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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.





With
our limited resources, we may be unable to effectively manage
growth.





As of the
date of this filing, we have three employees and several consultants and
independent contractors. The only consultant/contractor that we consider
critical to the Company is TheraCour, discussed in the next risk factor. KARD
Scientific, another consultant/contractor (See ITEM 1. Background:
Collaborations and Subcontract Arrangements) is considered by the Company
important but not critical as they are replaceable with moderate difficulty. All
other consultant/contractors would be more readily replaceable. While the
Company’s current operations cause it to be unlikely that we will need to grow
and hire additional consultants, contractors or employees, if future preclinical
studies of our nanoviricide drugs and technology show significant improvements
in efficacy over existing drugs, we intend to expand our operations and staff
materially. At that time our new employees may include a number of key
managerial, technical, financial, R&D and operations personnel who will not
have been fully integrated into our operations. We would expect the expansion of
our business to place a significant strain on our limited managerial,
operational and financial resources. We have no experience in integrating
multiple employees. Therefore, there is a substantial risk that we will not be
able to integrate new employees into our operations which would have a material
adverse effect on our business, prospects, financial condition and results of
operations.





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 30% 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.The Company controls the
research and work TheraCour performs on its behalf and no costs may be incurred
without the prior authorization or approval of the Company.





Development
costs charged by and paid to TheraCour Pharma, Inc. was $2,086,979 since
inception through June 30, 2008; No additional royalties are due to TheraCour
from the Company’s inception through June 30, 2008.





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.





40
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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:





£
            significant
      time and effort from our management
team;


£
            coordination
      of our marketing and R&D programs with the marketing and R&D
      priorities of our collaborators;
and








£
            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.





41
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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. Mr. Leo Ehrlich resigned as CFO in May 2007 and
his employment agreement is completed. Mr. Ehrlich now has a leak-out
agreement with the Company which limits the amount of stock Mr. Ehrlich and
affiliates can sell in each quarter. The remaining employment agreements provide
a minimum annual base salary of $200,000 for a term of three years. This base
salary has increased to $250,000 per year upon the financing that closed onOctober 15, 2007. 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.  The current Executive
Employment Agreement terminated onSeptember 30, 2008.The Company and two of
the Executives have verbally agreed that the Executives will continue to work
under the same terms until a new agreement is put into effect.





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 our stockholders will have any rights in
these ventures or their income or profits. Specifically, Anil Diwan owns
approximately 70% of the capital stock of TheraCour Pharma, Inc. which owns
approximately thirty percent (30%) of our Common Stock, provides the Company the
nanomaterials with which it intends to develop its products and is the 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 or any
transaction which has not been conducted on an arm’s length basis to date, Dr.
Diwan 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.  In particular:





£
            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.





42
 Table of Contents




£
            Our
      executive officers or directors or their affiliates have interests in
      entities that provide products or services to
  us.








In any of
these cases:





£
            Our
      executive officers or directors may have a conflict between our current
      interests and their personal financial and other interests in another
      business venture.








£
            Our
      executive officers or directors may have conflicting fiduciary duties to
      us and the other entity.








£
            The
      terms of transactions with the other entity may not be subject to arm’s
      length negotiations and therefore may be on terms less favorable to us
      than those that could be procured through arm’s length
      negotiations.








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:


o
            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;


o
            terminate
      our existing contracts;








o
            reduce
      the scope and value of our existing
contracts;


o
            audit
      and object to our contract-related costs and fees, including allocated
      indirect costs;








o
            control
      and potentially prohibit the export of our drug candidates;
      and


o
            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.





43
 Table of Contents





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 and other antiviral drugs in
the Strategic National Stockpile 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 for all of the
antiviral drugs that the governments may want to stockpile. 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.





44
 Table of Contents





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,
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
recently failed in Phase II human trials. Several H5N1 bird flu vaccines are
also in development worldwide.




We have
recently completed preliminary animal studies against HIV that have resulted in
the finding that certain of our drug candidates were superior to the oral HAART
cocktail in SCID_hu mice lethally infected with HIV-I. We thus believe that we
have a very strong lead drug identified against HIV. The analysis of results
from these studies has not been completed and the studies have not yet been
subjected to peer review. There are several companies with anti-HIV drugs
in the market. A new drug, maraviroc from Pfizer has recently been
approved, which falls in a new class called CCR5-blockers. Prior to this, two
new drugs in a new class called Integrase Inhibitors have been approved. A drug
in the class called Entry & Fusion Inhibitors, enfuvirtide, (Fuzeon((TM)),
Roche) has also been available. Additionally, the classical drugs, NRTI’s,
NNRTI’s and PI’s (protease inhibitors) are used in various combinations. The
HIVCide-I nanoviricide is expected to act by a very different kind of mechanism,
defining a new class of drugs, that is complementary to the existing classes of
anti-HIV drugs.





Our HCV
drugs are at the earliest stage of development. There are a growing number of
anti-HVC drugs being sold or in advanced stages of clinical development.
Companies with anti-HIV and HCV 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.




45
 Table of Contents




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;







£
            failure
      to receive the necessary regulatory approvals or a delay in receiving such
      approvals. Among other things, such delays may be caused by slow
      enrollment in clinical studies, length of time to achieve study endpoints,
      additional time requirements for data analysis or a IND and later NDA,
      preparation, discussions with the FDA, an FDA request for additional
      pre-clinical or clinical data or unexpected safety or manufacturing
      issues;







£
            manufacturing
      costs, pricing or reimbursement issues, or other factors that make the
      product not economical; and







£
            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 quoted on the "OTC Bulletin Board," your ability to sell
your shares in the secondary trading market may be limited.





Our
common stock is currently quoted on the OTC 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 OTC Bulletin Board at less than
$5.00 per share, our shares are "penny stocks" and may not be quoted 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:





£
            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.





46
 Table of Contents





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
June 30, 2008, the last trade price of our common stock, as quoted on the NASD
OTC Bulletin Board, was $1.38. The price may fluctuate significantly in response
to a number of factors, many of which are beyond our control. These factors
include:





£
            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;








£
            developments
      or disputes concerning patent or proprietary
  rights;


£
            general
      market conditions for emerging growth and pharmaceutical
      companies;








£
            economic
      conditions in the United States or
abroad;


£
            actual
      or anticipated fluctuations in our operating
  results;








£
            broad
      market fluctuations; and


£
            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 June
30, 2008, shareholders of the Company had 81,181,957 shares of restricted stock,
or 68.1% 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.








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.





47
 Table of Contents





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-K. While the Company
currently has no offers to sell its 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-K.





The
Company is authorized to issue up to 300,000,000 total shares of Common Stock
without additional approval by shareholders. As of  June 30, 2008, we
had 119,270,677 of common stock outstanding, and warrants and options
convertible to 6,250,000 shares of common stock outstanding.




Because
our common stock is quoted only on the OTC Bulletin Board, your ability to sell
your shares in the secondary trading market may be limited.'




Our
common stock is quoted only on the OTC 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 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
June 30, 2008, 81,181,957 of 119,270,677 issued and outstanding shares of the
Company’s common stock were 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
16,168,135 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 six month 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.





48
 Table of Contents





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.







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 that may adversely
affect the market price of our common stock and our stock price may decline
substantially.





ITEM 1B.  UNRESOLVED STAFF COMMENTS.





None.





ITEM 2. PROPERTIES





Description
of Property






The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 4,100 square feet of office and
laboratory space at a base monthly rent of $4,692. Commencing September 1, 2008
the Company rented additional storage space and the base monthly rent increased
to $4,892. The term of lease expires in February 28, 2011, and may be extended,
at the option of the Company, for an additional two years. The lease can be
cancelled by the Company upon providing six months written
notice.




On
February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000
square feet of space at 4 Research Drive, in Woodbridge, Connecticut. The
term of the occupancy is until January 30, 2009 at a monthly rent of $11,667,
plus an additional $500 per month for utilities.





We
subcontract the laboratory research and development work to TheraCour Pharma,
Inc. which has a 5,000 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).





49
 Table of Contents





ITEM 3: 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 4: Submission of Matters to Vote of Security
Holders.





None





PART
II




Item 5. Market For Registrant's Common
Equity  Related  Shareholder Matters and Issuer Purchases of
Equity Securities





Market
for Common Equity and Related Stockholder Matters





The
Company’s Common Stock was initially traded on the Pink Sheets under the symbol
NNVC. From June 29, 2007 the Company’s Common Stock has been quoted on the Over
The Counter Bulletin Board. The table below sets forth the high and low prices
for the Company’s Common Stock for the quarters included within 2006, 2007, and
2008. 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.





CHANGE
SCHEDULE


Quarter
      ended
                
                Low
      price
                
                
                High
      priceSeptember
      30, 2008
                
                $
                0.80
                
                
                $
                0.85June
      30, 2008
                
                $
                1.30
                
                
                $
                1.49March
      31, 2008
                
                $
                0.50
                
                
                $
                0.54December
      31, 2007
                
                $
                0.36
                
                
                $
                0.42September
      30, 2007
                
                $
                0.65
                
                
                $
                0.74June
      30, 2007
                
                $
                0.80
                
                
                $
                0.99March
      31, 2007
                
                $
                1.10
                
                
                $
                1.79December
      31, 2006
                
                $
                0.60
                
                
                $
                1.22September
      30, 2006
                
                $
                0.99
                
                
                $
                1.68








(1)
Effective date of reverse merger, June 1, 2005








Number of
Shareholders.





As of
June 30, 2008, a total of 119,270,677 the Company’s common stock (shares) are
outstanding and held by approximately 199 shareholders of record. Of this
amount, 38,059,024 shares are unrestricted. Approximately 29,004,365 shares are
restricted securities held by non-affiliates, and the remaining 52,177,592
shares are restricted securities held by affiliates. These shares may only be
sold in accordance with Rule 144. As of June 30, 2008, there were 4,375,000
warrants and 1,875,000 stock options to purchase the Company’s Common Stock
outstanding.





Dividends.





The
Company has not paid any cash 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





50
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Recent
sales of Unregistered Securities.





During
the fiscal years ended June 30, 2008 and 2007, the Company issued the following
securities exempt from the registration requirements of the Securities Act
pursuant to Section 4(2) of the Securities Act. No underwriting or other
compensation was paid in connection with these 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 debenture holders in lieu of
interest on debentures as set forth in the contract. The Company recorded an
interest expense of $7,644 for the month of July 2006.





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 $50,000 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 warrants to purchase
40,000 shares of common stock at $1.36 per share. These warrants, if not
exercised will expire in August 2010. The fair value of these warrants, by using
the Black-Scholes option pricing model, were valued at $30,184 and was recorded
as consulting expense.





In
November 2006, the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock common stock at $1.19 per
share.   These warrants, if not exercised will expire in November
2010.  The fair value of these warrants, by using the Black-Scholes
option pricing model, were valued at $25,888, and was recorded as
consulting expense.





On
January 2, 2007, the Company entered into consulting agreements for future
services with Dr. Randall Barton for scientific consulting, and Mr. Harry
Schochat, Esq. for legal consulting.  The company issued Dr. Randall
Barton 114,000 shares of its common stock and Mr. Harry Schochat, Esq. 102,000
shares of its common stock, for a total of 216,000 shares as upfront payments
(non-refundable) to these consultants. Based upon the fair market value of the
common stock on the commitment date, the Company recorded a consulting expense
of $164,160.





In
February 2007, the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock at $1.54 per share. These warrants, if
not exercised will expire in February 2011.The fair value of these warrants were
valued at $32,668 was recorded as consulting expense.





In May
2007, the Scientific Advisory Board (SAB) was granted warrants to purchase
40,000 shares of common stock at $1.30 per share. These warrants, if not
exercised will expire in May 2011.The fair value of these warrants in the amount
of $25,664 was recorded as consulting expense.





In June
2007, the Company's Board of Directors authorized the issuance of 752 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 $775.





In June
2007, 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 $115,000.





In June
2007, the Company's Board of Directors authorized the issuance of 15,791 shares
of its common stock with a restrictive legend to Dr. Randall Barton for
scientific consulting. Based upon the fair market value of the common stock on
the commitment date, the Company recorded a consulting expense of
$16,800.





In June
2007, the Company's Board of Directors authorized the issuance of 14,099 shares
of its common stock with a restrictive legend to Mr. Harry Schochat, Esq. for
legal consulting. Based upon the fair market value of the common stock on the
commitment date, the Company recorded a consulting expense of
$15,000.





In June
2007, 870,000 warrants were converted into common stock, resulting in the
issuance of 1,305,000 common shares. Company received $870,000 upon this
conversion in July, 2007.





In August
2007, the Scientific Advisory Board (SAB) was granted warrants to purchase
40,000 shares of common stock at $.80 per share. These warrants, if not
exercised will expire in August 2011 The fair value of these warrants, by using
the Black-Scholes option pricing model, were valued at $14,800 and was recorded
as consulting expense.





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On
September 21, 2007, the Company entered into a Subscription Agreement with DKR
Saturn Event Driven Holding Fund Ltd. (the "Investor") pursuant to which the
Company agreed to sell 1,500,000 shares (the "Shares") of its common stock, par
value $0.001 per share (the "Common Stock") and warrants (the "Warrants") to
purchase 450,000 shares of Common Stock (the "Warrant Shares") at an exercise
price of $1.00 per share for a purchase price of $750,000.  The
Warrants may be exercised at any time and expire in three years.  In
connection with the sale, the Company entered into a Registration Rights
Agreement with the Investor pursuant to which the Company agreed to file a
registration statement (the “Registration Statement”) with the Securities and
Exchange Commission ("SEC") on or before December 20, 2007 covering the resale
of the Shares, the Warrant Shares, and all shares of Common Stock issuable upon
any stock split, dividend or other distribution, recapitalization or similar
event involving the Common Stock. On January 3, 2008 the Company filed a
Form SB-2 with the Securities and Exchange Commission. This filing became
effective as of April 11, 2008.





In
September, 2007, the Company had received fully paid subscriptions in the
aggregate amount of $1,625,000 through the offering of shares of the Company’s
Common Stock (the “Offering”). The subscriptions are for shares of common stock
at a purchase price of $.50 per share and warrants to purchase 0.30 shares of
common stock at an exercise price of $1.00 per share; which warrants may be
exercised at any time and expire in three years. In accordance with the
Offering, on October 16, 2007, the Company sold 3,250,000 shares of common stock
and warrants to purchase 975,000 shares of common stock at an exercise price of
$1.00 per share. The warrants may be exercised at any time and expire in three
years.





In
October, 2007, the Company had received fully paid subscriptions in the
aggregate amount of $125,000 through the offering of shares of the Company’s
Common Stock (the “Offering”). The subscriptions are for shares of common stock
at a purchase price of $.50 per share and warrants to purchase 0.30 shares of
common stock at an exercise price of $1.00 per share; which warrants may be
exercised at any time and expire in three years. In accordance with the
Offering, on October 16, 2007, the Company sold 250,000 shares of common stock
and warrants to purchase 75,000 shares of common stock at an exercise price of
$1.00 per share. The warrants may be exercised at any time and expire in three
years.





In
September 2007, the Company's Board of Directors authorized the issuance of
13,899 shares of its common stock with a restrictive legend to Dr. Randall
Barton for scientific consulting. Based upon the fair market value of the common
stock on the commitment date, the Company recorded a consulting expense of
$8,400.





In
September 2007, the Company's Board of Directors authorized the issuance of
11,345 shares of its common stock with a restrictive legend to Mr. Harry
Schochat, Esq. for legal consulting. Based upon the fair market value of the
common stock on the commitment date, the Company recorded a consulting expense
of $15,000.





In
November 2007, the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock common stock at $.54 per
share.   These warrants, if not exercised will expire in November
2011  The fair value of these warrants, by using the Black-Scholes
option pricing model, were valued at $7,200, and was recorded as consulting
expense.





In
December 2007, the Company's Board of Directors authorized the issuance of
25,820 shares of its common stock with a restrictive legend to Dr. Randall
Barton for scientific consulting. Based upon the fair market value of the common
stock on the commitment date, the Company recorded a consulting expense of
$11,900.





In
December 2007, the Company's Board of Directors authorized the issuance of
31,332 shares of its common stock with a restrictive legend to Mr. Harry
Schochat, Esq. for legal consulting. Based upon the fair market value of the
common stock on the commitment date, the Company recorded a consulting expense
of $15,000





In
February 2008, the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $.53 per share. These warrants, if not
exercised will expire in February 2012.The fair value of these warrants were
valued at $8,500 was recorded as consulting expense.





In March
2008 the Company's Board of Directors authorized the issuance of 18,530 shares
of its common stock with a restrictive legend to Dr. Randall Barton for
scientific consulting. Based upon the fair market value of the common stock on
the commitment date, the Company recorded a consulting expense of
$8,400.





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In March
2008, the Company's Board of Directors authorized the issuance of 33,089 shares
of its common stock with a restrictive legend to Mr. Harry Schochat, Esq. for
legal consulting. Based upon the fair market value of the common stock on the
commitment date, the Company recorded a consulting expense of
$15,000.





In March
2008 the Company's Board of Directors authorized the issuance of 9,927 shares of
its common stock with a restrictive legend to Udayan Gupta for consulting
services. Based upon the fair market value of the common stock on the commitment
date, the Company recorded a consulting expense of $4,500.





In April
2008 the Company's Board of Directors authorized the issuance of 27,750 shares
of its common stock with a restrictive legend to Friedland Investment Events,
LLC for consulting. Based upon the fair market value of the common stock on the
commitment date, the Company recorded a consulting expense of
$10,823





In May
2008, the Scientific Advisory Board (SAB) was granted warrants to purchase
50,000 shares of common stock at $1.48 per share. These warrants, if not
exercised will expire in May 2012.The fair value of these warrants in the amount
of $32,253 was recorded as consulting expense.





In June
2008 the Company's Board of Directors authorized the issuance of 8,983 shares of
its common stock with a restrictive legend to Dr. Randall Barton for scientific
consulting. Based upon the fair market value of the common stock on the
commitment date, the Company recorded a consulting expense of
$8,400.





In June
2008, the Company's Board of Directors authorized the issuance of 16,046 shares
of its common stock with a restrictive legend to Mr. Harry Schochat, Esq. for
legal consulting. Based upon the fair market value of the common stock on the
commitment date, the Company recorded a consulting expense of
$15,000.





In June
2008 the Company's Board of Directors authorized the issuance of 4,812 shares of
its common stock with a restrictive legend to Udayan Gupta for consulting
services. Based upon the fair market value of the common stock on the commitment
date, the Company recorded a consulting expense of $4,500.





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 6. SELECTED FINANCIAL DATA





Not
applicable for smaller reporting companies.








ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS





The
following discussion should be read in conjunction with the information
contained in the consolidated financial statements of the Company and the notes
thereto appearing elsewhere herein and in conjunction with the Management's
Discussion and Analysis of Financial Condition and Results of Operations set
forth in (1) the Company's Annual Report on Form 10-K for the year ended
June 30, 2007. Readers should carefully review the risk factors disclosed
in this Form 10-K and other documents filed by the Company with the
SEC.





As used
in this report, the terms "Company", "we", "our", "us" and "NNVC" refer to
Nanoviricides, Inc., a Nevada corporation.





PRELIMINARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS





This
Annual Report contains forward-looking statements within the meaning of the
federal securities laws. These include statements about our expectations,
beliefs, intentions or strategies for the future, which we indicate by words or
phrases such as "anticipate," "expect," "intend," "plan," "will," "we believe,"
"NNVC believes," "management believes" and similar language. The forward-looking
statements are based on the current expectations of NNVC and are subject to
certain risks, uncertainties and assumptions, including those set forth in the
discussion under "Management's Discussion and Analysis of Financial Condition
and Results of Operations" in this report. Actual results may differ materially
from results anticipated in these forward-looking statements. We base the
forward-looking statements on information currently available to us, and we
assume no obligation to update them.





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Investors
are also advised to refer to the information in our previous filings with the
Securities and Exchange Commission (SEC), especially on Forms 10-K,10-Q and 8-K,
in which we discuss in more detail various important factors that could cause
actual results to differ from expected or historic results. It is not
possible to foresee or identify all such factors. As such, investors should not
consider any list of such factors to be an exhaustive statement of all risks and
uncertainties or potentially inaccurate assumptions.





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. This 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. Additionally, TheraCour has permitted the Company to use its
nanomaterials to develop a treatment against Dengue Fever viruses, Ebola/Marburg
viruses, and viruses causing certain eye diseases. The Company anticipates
negotiating with TheraCour an amendment to the Licensing Agreement to include
those of these additional viruses that the Company determines it wants to follow
for further development. 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.





To date,
we have engaged in organizational activities; developing and sourcing compounds
and preparing nano-materials; and experimentation involving preclinical studies
using cell cultures and animals. We have generated funding through the issuances
of debt and private placement of common stock (see Item 5 Recent Sales of
Unregistered Securities). We 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 we may not
become profitable in the future. We have incurred net losses in each fiscal
period since inception of our operations.





Collaborative
Agreements and Contracts





On
December 23, 2005, the Company signed a Memorandum of Understanding (MOU) 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 NanoViricides will retain all intellectual property
rights with respect to any resulting product and 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(TM)-I, AviFluCide-I(TM) and
AviFluCide-HP(TM) were successfully performed at the laboratories of the
National Institute of Hygiene and Epidemiology in Hanoi (NIHE), against both
clade 1 and clade 2 of H5N1 virus isolated in Vietnam. Successful animal
testing of  RabiCide-I(TM), the company’s rabies drug, was performed
in Vietnam during the first half of 2007, and reproducibly repeated in 2008.
Rabies testing can safely be done at their BSL2 facility. The H5N1 animal
testing requires a BSL3 (biological safety laboratory level 3) laboratory. NIHE
has acquired a BSL3 animal testing capacity during 2008.  The work with
NIHE will likely continue through calendar year 2009. While the MOU provides for
a final agreement between the Company and NIHE, we have not yet discussed a
“final agreement” with NIHE and continue to work under the existing MOU. There
are no financial obligations or responsibilities for either the Company or NIHE
pursuant to the provisions of the MOU.





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We have
finalized execution of a Materials Cooperative Research and Development
Agreement (M-CRADA) with the Centers for Disease Control and Prevention (CDC),
Atlanta, GA in July, 2008. This agreement was initiated based on our success
against Rabies in the animal studies conducted at NIHE Vietnam. Preliminary
animal studies against Rabies are expected to start in the last quarter of
calendar year 2008 or first quarter of calendar year 2009. Subsequent to the
agreement execution, the Company has supplied certain materials to CDC for
testing. This testing, if successful, is expected to expand to involve potential
use of nanoviricides as (1) a post-infection therapeutic
drug against rabies, possibly in conjunction with a rabies vaccine, and (2) a
post-exposure
prophylactic drug against rabies, to replace costly human or monoclonal
antibodies, possibly in conjunction with a rabies vaccine. To date, there is no
effective post-infection therapeutic against rabies. Post-exposure prophylaxis
market has been estimated to be as much $300M to $500M worldwide.





We have
finalized a CRADA with Walter Reed Army Institutes of Research (WRAIR) to
develop collaboratively antiviral agents against all four types of dengue
viruses in April, 2007.  Preliminary work has commenced under this
CRADA. This CRADA is expected to be renegotiated due to changes in funding
requirements at WRAIR.





We have
finalized a Materials Transfer Agreement (MTA) with the United States Army
Institute of Infectious Diseases (USAMRIID) to develop antiviral agents against
Ebola, Marburg and other hemorrhagic viruses in October 2007. Preliminary
studies began in February, 2008. Certain nanoviricides candidates were found to
be highly successful against Ebola virus in pre-clinical cell culture studies.
Ebola virus is known to produce, in vivo, a soluble decoy protein that is a
portion of its surface glycoprotein. If the nanoviricides that were successful
in the in vitro studies bind to the decoy protein portion of the Ebola virus
envelope, then we would expect that the nanoviricides would be neutralized in
vivo by the decoy protein. We are therefore developing novel ligands that would
potentially bind to the Ebola virus glycoprotein portion that is known to be not
a part of the decoy protein. The MTA was extended for another year in October,
2008 to continue these studies.





We have
finalized a CRADA with Armed Forces Institute of Pathology (AFIP) to perform
animal studies against H5N1 in March, 2008. The animal protocols are in review
for final approval by their animal care committee.





We have
finalized an agreement with a major Medical Institute to perform animal studies
of our eye drop formulation of nanoviricides against viral EKC (viral Epidemic
Kerato-conjunctivitis) in March, 2008. The first EKC-Cide(TM)-I animal study was
completed in June, 2008. Biochemical testing of the samples is continuing. The
study indicated that the best nanoviricide drug candidate showed excellent
clearance of clinical signs of the disease, viz. redness of the eye as well as
sticky exudates, in a short time after treatment. We have received significant
interest from certain Pharmaceutical companies in this drug
candidate.





We have a
continuing job-based subcontract relationship with KARD Scientific, Inc.,
Beverly, MA.  KARD Scientific is owned and operated by Dr. Krishna
Menon, who also serves as Chief Regulatory Officer to NanoViricides, Inc. in a
consulting capacity. KARD Scientific has performed repeated studies of
nanoviricides against common influenza. KARD Scientific also conducted certain
efficacy studies of nanoviricides drug candidates against HIV in SCID-hu/Thy/Liv
mouse model beginning in March, 2008. The results from this study are being
compiled. Significantly, the best nanoviricide drug candidate showed viral load
reduction that was superior to that of animals treated with the oral HAART
3-drug cocktail. This drug candidate also showed superior survival of mice as
compared to those given the standard cocktail. If these preliminary results
continue to hold in further studies, and later in humans, the Company believes
that, either alone or conjunction with existing anti-HIV drugs, it should be
possible to develop a “Functional Cure” for HIV/AIDS as defined by NIAID, using
our anti-HIV nanoviricides. Our belief is based on the excellent efficacy
profile of these drug candidates, their excellent safety profile, and the
understanding that the mechanism of nanoviricide action is complementary to that
of the other anti-HIV drugs.





The
Company’s Drug Pipeline





Management
believes that it has achieved significant milestones in the development of a
number of antiviral nanoviricide drug candidates. We now have high efficacy lead
drug candidates against (1) common Influenza (FluCide-I), (2) all High Path
Avian Influenzas including H5N1 (FluCide-HP), (3) Rabies (RabieCide-I), (4)
viral EKC (EKCCide-I), and (5) HIV (HIVCide-I).  In addition, the
Company has also established the technology feasibility for (a) broad-spectrum
nanoviricides, and (b) Just-in-Time ADIF technology; both of which are well
suited for stockpiling to defend against known as well as novel infectious
diseases.





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The
Company has not yet performed detailed safety profile studies to be included in
a “Tox Package” for submission to the FDA for any of our drug candidates. Our
studies regarding safety of the various nanoviricide drug candidates to date
have been preliminary and of a limited nature.





Management’s
beliefs are based on results of pre-clinical cell culture studies and in vivo
animal studies using mice.





The
Company thus has a strong and growing drug pipeline to take us several years
into the future. The Company already has technologies in development that
promise to yield even better drugs against various diseases as the drugs we are
developing now approach their product end of lifecycle.





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
various anti-viral drugs.  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 budgeted
obligations for the next twelve months and we may not be able to obtain the
necessary financing. As of June 30, 2008 we have a cash balance of $816,386
which can support operations through January 1, 2009.  We expect to
incur costs of approximately $3-5 million dollars in the upcoming twelve months
to operate our business in accordance with our business plans.  If we
are unable to obtain additional financing, our business plan will be
delayed.





On August
22, 2008, the Company consummated subscriptions with certain investors whereby
the Company sold 3,286,000 shares (the “Shares”) of its common stock , par
value$0.001 per share (the “Common Stock”) and Warrants (“Warrants”) to purchase
1,643,000 shares of  Common Stock at an exercise price of $2.00 per
share for an aggregate purchase price of $3,286,000. The 3,286,000 share private
placement of stock included 150,000 shares of Common Stock
subscribed  and 75,000 warrants in consideration of $150,000 of
scientific testing and other laboratory work performed for the
Company.  The Warrants may be exercised at any time and expire on
September 17, 2011.





Also on
August 22, 2008, the Company consummated subscriptions with certain of its
Warrant holders whereby the Company offered all the holders of its $2.50
Warrants the option of exercising the Warrants at $1.00 per share of Common
Stock, of which warrants to purchase 50,000 shares of Common Stock for an
aggregate price of $50,000 were exercised. Concurrently, the Company consummated
subscriptions with certain other of its Warrant holders whereby the Company
offered all the holders of its $1.00 Warrants the option of exercising the
Warrants at $0.75 per share of Common Stock, of which warrants to purchase
75,000 shares of Common Stock for an aggregate price of $56,250 were
exercised.





We expect
we will require between $3,000,000 and $5,000,000 to execute the first part of
our business plan which covers operations through June 30, 2009. 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-1(TM), AviFluCide(TM), FluCide HP(TM), and Rabies planned for the
      year ended June 30, 2009. The Company has allocated the planned costs of
      $1,200,000 evenly over the seven drug candidates. Depending on the results
      of these clinical trials, we expect to commence with early stage
      development of a drug for HIV for which we have budgeted
      $300,000.





2
            Corporate
      overhead of $750,000: This amount includes budgeted office salaries,
      legal, accounting and other costs expected to be incurred by being a
      public reporting company.





3
            Capital
      costs of $1,250,000: This is the estimated cost for equipment and
      laboratory improvements. The Company will incur these costs based on the
      results of trials in the third calendar quarter of 2007 indicating
      improvement over present
treatments.





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4
            Staffing
      costs of $1,500,000: This is the estimated cost of hiring additional
      scientific staff and consulting firms to assist with FDA compliance,
      material characterization, pharmaco-kinetic, pharmaco-dynamic and
      toxicology studies, as required for development of necessary data for
      filing an Investigational New Drug Application (IND) with the United
      States Food and Drug
Administration.





The
Company will be unable to proceed with its planned drug development, meet its
administrative expense requirements, capital costs, and staffing costs without
obtaining additional financing of approximately $3,000,000 to
$5,000,000.  If we are unable to obtain additional financing, our
business plan will be significantly delayed or curtailed.





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. Because at this time all the Company’s projects share
a common core material, the Company allocates expenses across all projects at
each period-end for purposes of providing accounting basis for each project.
Project costs are allocated based upon labor hours performed for each
project.




The
Company has signed several cooperative research and development agreements with
different agencies and institutions.





The
Company expects to enter into additional cooperative agreements with other
governmental and non-governmental, academic, or commercial, agencies,
institutions, and companies. There can be no assurance that a final agreement
may be achieved and that the Company will execute any of these agreements.
However, should any of these agreements materialize, the Company will
implement a system to track these costs by project and account for these
projects as customer-sponsored activities and show these project costs
separately.





The
following table summarizes the primary components of our research and
development expenses as allocated, during the periods presented in this Form
10K.




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Year
      Ended June 30, 2008
                      
                      
                      Year
      Ended June 30, 2007
                      
                      
                      For
      the Cumulative
                        Period
      From
                        May
      12, 2005 (Inception) through
                        June 30, 2008All
      Influenzas: FluCide(TM), FluCide-HP, and AviFluCide
                      
                      
                      194,127
                      
                      
                      
                      607,400
                      
                      
                      
                      1,527,444EKC-Cide(TM)
                      
                      
                      270,200
                      
                      
                      
                      0
                      
                      
                      
                      270,200HIV-Cide(TM)
                      
                      
                      440,100
                      
                      
                      
                      0
                      
                      
                      
                      440,100RabiCide(TM)
                      
                      
                      65,500
                      
                      
                      
                      65,863
                      
                      
                      
                      252,349Other
      (includes dengue, Ebola, and other projects)
                      
                      
                      69,500
                      
                      
                      
                      58,545
                      
                      
                      
                      211,804Total
      Research and development
                      
                      
                      1,039,427
                      
                      
                      
                      731,808
                      
                      
                      
                      2,701,897





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(TM) for Common InfluenzaCurrent
      status
                              FluCide-I,
      is currently in preclinical studies against all common influenzas as well
      as avian influenza H5N1. It is a broad-spectrum anti-influenza
      nanoviricide. It is based on a well-known ligand mechanism by which
      influenza viruses bind to cells. This mechanism involves the hemagglutinin
      coat protein of influenza virus binding to sialic acids on cell surfaces.
      FluCide-I has been tested in cell cultures and in mice and has
      demonstrated better results than oseltamivir. The Company is planning
      in-vivo and in-vitro studies with FluCide-I at various institutions and
      subcontractors.Nature,
      timing and estimated costs
                              We
      believe that we will continue with FluCide-I as a drug candidate. The
      Company has budgeted approximately $500,000 for the material development,
      production and testing of this drug during the first calendar quarter of
      2009. These costs will be paid from our available cash balances. Should
      management determine the results to be satisfactory, we will need to
      obtain additional financing to perform material characterization,
      pharmaco-kinetic, pharmaco-dynamic and toxicology studies, which we have
      presently budgeted at $1,000,000.Anticipated
      completion date
                              Not
      knownRisks
      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 cannot 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.




58
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Project
                              Drug
      Development of AviFluCide(TM) for Avian InfluenzaCurrent
      status
                              AviFluCide
      is a specific anti-H5N1 anti-influenza nanoviricide. It is based on an
      antibody provided to us by the NIHE, Vietnam by which influenza viruses
      bind to cells. AviFluCide has been tested in cell cultures and has
      demonstrated better results than oseltamivir. Given the high efficacy
      demonstrated by FluCide-HP against H5N1, the Company has decided to
      abandon the development of the more expensive and troublesome
      antibody-based drug, viz. AviFluCide.Nature,
      timing and estimated costs
                              The
      Company has chosen to stop AviFluCide (H5N1-only) drug development, and to
      promote the development of FluCide-HP instead. FluCide-HP is expected to
      work against all High Path Avian Influenzas (HPAI), rather than H5N1
      alone.Anticipated
      completion date
                              Project
      completed successfully.Risks
      and uncertainties associated with completing development on schedule, and
      the consequences to operations, financial position and liquidity if not
      completed timely
                              The
      development was terminated due to the high success of FluCide-HP. This
      project demonstrated the technical feasibility of our
      ADIF(TM) “Accurate-Drug-In-Field” technology which is well suited for
      tackling novel and emerging viruses in bio-defense
      applications.Timing
      of commencement of expected material net cash inflows
                              Project
      terminated.








Project
                            Drug
      Development of FluCideHP(TM) for all High Pathogenic Avian
      InfluenzasCurrent
      status
                            FluCide-HP,
      is currently in preclinical studies against all common influenzas as well
      as various highly pathogenic avian influenzas with pandemic potential,
      including H5N1, H7N and H9N. It is a broad-spectrum anti-influenza
      nanoviricide. It is based on a well-known ligand mechanism by which
      influenza viruses become highly pathogenic to humans. This mechanism
      involves the hemagglutinin coat protein region of influenza virus protein
      called the polybasic site. FluCide-HP has been tested in cell cultures and
      in mice and has demonstrated better results than oseltamivir. The Company
      is planning further in-vivo and in-vitro studies with FluCide-HP at
      various institutions and subcontractors.Nature,
      timing and estimated costs
                            The
      Company has budgeted approximately $500,000 for the material development,
      production and testing of this drug during the year ending June 30, 2009.
      These costs will be paid from our available cash balances. Should
      management determine the results to be satisfactory, we will need to
      obtain additional financing to perform material characterization,
      pharmaco-kinetic, pharmaco-dynamic and toxicology studies, which we have
      presently budgeted at $1,000,000.Anticipated
      completion date
                            Not
      knownRisks
      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 cannot 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.




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Project
                              Drug
      Development of RabiCide(TM) for RabiesCurrent
      status
                              RabiCide, is currently in
      preclinical studies against rabies. It is a broad-spectrum anti-influenza
      nanoviricide. It is based on a well-known ligand mechanism by which rabies
      viruses bind to cells. Rabicide has been successfully tested in mice. The
      Company is planning additional in-vivo and in-vitro studies with RabiCide
      at the Vietnam National Institute of Hygiene and Epidemiology (NIHE) and
      at the CDC during 2008-2009.Nature,
      timing and estimated costs
                              The
      Company has budgeted approximately $300,000 for the material development,
      production and testing of this drug. 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 $500,000.Anticipated
      completion date
                              Not
      knownRisks
      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 cannot 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 EKCCide(TM) for Viral EKCCurrent
      status
                                EKC-Cideis currently in
      preclinical studies against viral EKC. It is a broad-spectrum anti-viral
      nanoviricide eye drops solution. It is based on a well-known ligand
      mechanism by which adenoviruses and herpes-viruses bind to cells. EKC-Cide
      has been successfully tested in rabbits against adenoviral EKC. The
      Company is planning additional in-vivo and in-vitro studies with EKCCide
      against adenoviral EKC as well as Herpes viral keratitis at various
      institutions and subcontractors during 2008-2009.Nature,
      timing and estimated costs
                                The
      Company has budgeted approximately $500,000 for the material development,
      production and testing of this drug. These costs will be paid from our
      available cash balances. Should management determine the results to be
      satisfactory, we will need to obtain additional financing to perform
      material characterization, pharmaco-kinetic, pharmaco-dynamic and
      toxicology studies, which we have presently budgeted at $1,000,000.Anticipated
      completion date
                                Not
      knownRisks
      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 cannot 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.




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Project
                              Drug
      Development of HIV-Cide(TM) for HIV/AIDSCurrent
      status
                              HIV-Cideis currently in
      preclinical studies against HIV/AIDS. It is a HIV-specific anti-viral
      nanoviricide. It is based on a well-known ligand mechanism by which HIV
      binds to various cellular receptors. HIV-Cide has been successfully tested
      in SCID-hu mice against HIV. The Company is planning additional in-vivo
      and in-vitro studies with HIV-Cide against HIV at various institutions and
      subcontractors during 2008-2009.Nature,
      timing and estimated costs
                              The
      Company has budgeted approximately $1,500,000 for the material
      development, production and testing of this drug. 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 $2,500,000.Anticipated
      completion date
                              Not
      knownRisks
      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 cannot 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 candidates:  nanoviricides for
Ebola/Marburg, Dengue, HCV, and several other viral diseases are at a various
early stages of research and development and involve a substantial amount of
uncertainty as to the development of these drug candidates. At this time, very
little resources have been allocated to these drugs. However should the early
studies of any of these drug candidates provide an indication of high efficacy,
the corresponding drug candidate will become a full-fledged drug development
project and the Company will endeavor to seek additional monies for the
necessary drug development work.





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 used in human clinical trials. It is
preferable to use the same quality of materials 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 2010-2011 fiscal year,
subject to available research and development funds. 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.





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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 further, studies on acute viral infectious diseases are expected to 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. Management intends to pursue non-diluting funding sources such as
government grants and contracts as well as licensing agreements with other
pharmaceutical companies. 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, 2008, contains
an explanatory paragraph regarding a substantial doubt about our ability to
continue as a going concern.





Results
of Operations





The
Company is a development-stage biopharmaceutical company and does not have
revenue for the year ending June 30, 2008.





Revenues- The Company is
a non-revenue producing entity.





Operating
Expenses-
General and administrative expenses decreased $398,300 from $2,351,104 for the
year ended June 30, 2008 to $1,952,804 for the year ended June 30,
2007.  The decrease resulted from a consolidation of non-research and
development oriented services.





Research
and development expenses for the year ended June 30, 2008 increased $307,619 to
$1,039,427 from $731,808 for the year ended June 30, 2007.  This
increase in the cost of Research and development is largely attributable to the
development of additional drug candidates.





Research
and Development expenses were offset in the amount of $200,190 by a Connecticut
Refundable Research and Development Creidt.





Other Income
(Expenses)– Net
Interest income was $53,704 and $54,511 for the years ending June 30, 2008 and
2007, respectively. Net Interest income in 2008 included interest on cash
equivalent deposits in an interest-bearing account.





Interest
expense in 2007 included amortization of loan costs, debt discounts, and
beneficial conversion features of convertible debentures.





Income Taxes–There is no provision
for income taxes due to ongoing operating losses. As of June 30, 2008, we had
federal net operating loss carryforwards of approximately $6,702,000 resulting
in a tax benefit of approximately $2,901,100 for Federal reporting
purposes.  This amount has been offset by a full valuation
allowance.





Net Operating
Loss-For the
year ended June 30, 2008, the Company had a net loss of $2,738,337, or $0.02 per
share compared to a net loss of $3,118,963, or $0.03 per share for the year
ending June 30, 2007.





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Liquidity
and Capital Reserves





The
Company had cash and cash equivalents of $816,386 as of June 30,
2008.  On the same date, accounts payable and accrued liabilities
outstanding totaled $1,024,511.





Since
inception, the Company has expended substantial resources on research and
development. Consequently, we have sustained substantial losses.   The
Company has an accumulated deficit of $9,207,737 at June 30, 2008.





The
Company’s current financial condition raises doubt as to its ability to continue
as a going concern.  The report of the Company’s independent public
accountants, which accompanied the financial statements for the year ended June
30, 2008, contained going concern language.  On August 22, 2008, the
Company had accepted subscriptions for shares of the Company’s common stock and
the exercise of warrants in the aggregate amount of
$3,286,000.00.  While this sum should be sufficient for us
to continue our operations through the current fiscal year, it is not enough for
us to execute the first phase of the Company’s business plan. If the
Company is unable to obtain debt or equity financing to meet its cash needs it
may have to severely limit, its business plan by reducing the funds it hopes to
expend on pre-clinical studies and trails, the establishment of our own
laboratory and/or research and development project.








Off
Balance Sheet Arrangements





We have
not entered into any off-balance sheet arrangements during the year ended June
30, 2008.





CRITICAL
ACCOUNTING POLICIES AND ESTIMATES





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 operations 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 years ended June 30, 2007 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 if they were for past services.








POLICY
AFFECTING RECOGNITION OF REVENUE





The
Company is a development stage company and does not have revenue arising from
operations





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RECENT
ACCOUNTING PRONOUNCEMENTS





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 as required
under other accounting pronouncements. SFAS No. 157 is effective for financial
statements beginning with fiscal year beginning after November 15,2007, and
interim periods within those fiscal years. In February, 2008, the FASB issued
FASB Staff position No. FAS 157-1 (FSP FAS 157-1) which excludes SFAS No. 13,
from the scope of SFAS 157.  In February 2008, the FASB issued FASB
Staff Position No.157-2 (FSP 157-2) which provides a one year delayed
application of SFAS 157 for non financial assets and liabilities, except for
items that are recognized  or disclosed at fair value in the
financial statements on a recurring basis ( at least annually). We are required
to adopt SFAS 157 as amended by FSP FAS 157-1 and FSP FAS 157-2 On July 1, 2008
The Company is in the process of assessing the effect SFAS No. 157 may have on
its financial statements. The adoption is not
expected  to have a material impact on our financial statements
..





In
February 2007, the FASB issued SFAS No. 159, "Establishing the Fair Value Option
for Financial Assets and Liabilities" ("SFAS 159") to permit all entities to
choose to elect to measure eligible financial instruments and certain other
items at fair value. The decision whether to elect the fair value option may
occur for each eligible item either on a specified election date or according to
a preexisting policy for specified types of eligible items. However, that
decision must also take place on a date on which criteria under SFAS 159 occurs.
Finally, the decision to elect the fair value option shall be made on an
instrument-by-instrument basis, except in certain circumstances. An entity shall
report unrealized gains and losses on items for which the fair value option has
been elected in earnings at each subsequent reporting date. SFAS 159 applies to
fiscal years beginning after November 15, 2007. The Company is currently
evaluating this pronouncement.





In June
2007, the FASB ratified the consensus reached by the EITF on Issue No. 07-3
(EITF 07-3), Accounting for Nonrefundable Advance Payments for Goods or Services
Received for Use in Future Research and Development Activities. Pursuant to EITF
07-3, nonrefundable advance payments for goods or services that will be used or
rendered for future research and development activities should be deferred and
capitalized. Such amounts should be recognized as an expense when the
related goods are delivered or services are performed, or when the goods or
services are no longer expected to be received. This Issue is effective for us
beginning July 1, 2008, and is to be applied prospectively for contracts entered
into on or after the effective date. We do not anticipate the
implementation of this Issue to be material to our financial position or results
of operations.





In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force (ETIF) on Issue No. 07-1 (EITF 07-1), Accounting for Collaborative
Arrangements. EITF 07-1 defines collaborative arrangements and establishes
reporting requirements for transactions between participants in a collaborative
arrangement and between participants in the arrangement and third parties. This
Issue is effective for us beginning July 1, 2009 and will be applied
retrospectively to all prior periods presented for all collaborative
arrangements existing as of the effective date. While we have not yet completed
our analysis, we don not anticipate the implementation of this Issue to be
material to our consolidated financial position or results of
operations.





In March
2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments
and Hedging Activities," and Amendment of FASB Statement No. 133. SFAS 161
amends SFAS 133, "Accounting for Derivative Instruments and Hedging Activities,"
to amend and expand the disclosure requirements of SFAS 133 to provide greater
transparency about (i) how and why an entity uses derivative instruments, (ii)
how derivative instruments and related hedge items are accounted for under SFAS
133 and its related interpretations, and (iii) how derivative instruments and
related hedged items affect an entity's financial position, results of
operations and cash flows. To meet those objectives, SFAS 161 requires
qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of gains and losses on
derivative instruments and disclosures about credit-risk-related contingent
features in derivative agreements. SFAS 161 is effective for fiscal years and
interim periods beginning after November 15, 2008. Earlier adoption is
encouraged. The Company is currently evaluating the impact of SFAS 161 on its
financial position, results of operations or cash flows.





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In May
2008, the FASB issued SFAS No. 162, "The Hierarchy of Generally Accepted
Accounting Principles" ("SFAS 162"). SFAS 162 is intended to improve financial
reporting by identifying a consistent framework, or hierarchy, for selecting
accounting principles to be used in preparing financial statements that are
presented in conformity with U.S. GAAP for nongovernmental entities. SFAS 162 is
effective 60 days following the Securities and Exchange Commission's approval of
the Public Company Accounting Oversight Board auditing amendments to AU Section
411, "The Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles." The Company does not expect SFAS 162 to have a material
effect on its financial statements.





In May
2008, the FASB issued FSP APB 14-1, "Accounting for Convertible Debt Instruments
That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlements)." This FSP requires a portion of this type of convertible debt to
be recorded as equity and to record interest expense on the debt portion at a
rate that would have been charged on nonconvertible debt with the same terms.
This FSP takes effect in the first quarter of fiscal years beginning after
December 15, 2008 and will be applied retrospectively for all periods presented.
It will effective for the Company on July 1, 2009. This FSP would apply to the
Company's convertible debentures. The Company is currently evaluating how it may
affect the financial statements.  The Company does not currently have
any convertible debt instruments.





In June
2008, the FASB issued Staff Position ("FSP") EITF 03-6-1, "Determining Whether
Instruments Granted in Share-Based Payment Transactions Are Participating
Securities." Securities participating in dividends with common stock according
to a formula are participating securities. This FSP determined unvested shares
of restricted stock and stock units with nonforfeitable rights to dividends
are participating securities. Participating securities require the
"two-class" method to be used to calculate basic earnings per share. This method
lowers basic earnings per common share. This FSP takes effect in the first
quarter of fiscal years beginning after December 15, 2008 and will be applied
retrospectively for all periods presented. It will be effective for the Company
on July 1, 2009. The Company does not expect FSP EITF 03-6-1 to have a material
effect on its financial statements.








ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK





The
Company is not exposed to market risk related to interest rates on foreign
currencies.






ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA





The
information required by Item 8 appears after the signature page to this
report.





ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURES





None





ITEM9A(T). CONTROLS AND PROCEDURES





ITEM
9A(T). CONTROLS AND PROCEDURES




Evaluation
of Disclosure Controls and Procedures





We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our Exchange Act reports is recorded,
processed, summarized and reported within the time periods specified in the
Securities and Exchange Commission’s rules and forms and that such information
is accumulated and communicated to our management, including our chief executive
and chief financial officer, as appropriate, to allow for timely decisions
regarding required disclosure. Disclosure controls and procedures, no matter how
well designed and operated, can provide only reasonable assurance of achieving
the desired control objectives, and management is required to apply its judgment
in evaluating the cost-benefit relationship of possible controls and procedures.
Management has designed our disclosure controls and procedures to provide
reasonable assurance of achieving the desired control objectives.





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As
required by Exchange Act Rule 13a-15(b), we have carried out an evaluation,
under the supervision and with the participation of our management, including
our principal executive and principal financial officer, of the effectiveness of
the design and operation of our disclosure controls and procedures as of June
30, 2008. Based upon this evaluation, our principal executive officer and
principal financial officer concluded that our disclosure controls and
procedures were not effective as of June 30, 2008 because of the material
weaknesses discussed below. Notwithstanding the material weaknesses discussed
below, our management has concluded that the  financial statements included
in this Annual Report on Form 10-K fairly present in all material respects our
financial condition, results of operations and cash flows for the periods
presented in conformity with generally accepted accounting
principles.





The
company believes that it has taken steps for remediation of these
weaknesses.





Management’s
Report on Internal Control Over Financial Reporting





Management
is responsible for establishing and maintaining adequate internal control over
financial reporting as defined in Rules 13a-15(f) under the Securities
Exchange Act of 1934, as amended. Internal control over financial reporting is
designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles in the United States of
America (“GAAP”). We recognize that because of its inherent limitations,
internal control over financial reporting may not prevent or detect
misstatements. Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies
and procedures may deteriorate.





To
evaluate the effectiveness of our internal control over financial reporting,
management used the criteria described in Internal Control — Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (“COSO”).





In
connection with management’s assessment of our internal control over financial
reporting, we identified the following material weaknesses in our internal
control over financial reporting as of June 30, 2008:





1.  Timeliness of
Financial Reporting:Our Chief Executive Officer and Interim Chief
Financial Officer concluded that the Company's controls were not effective as of
June 30, 2008 due to inherent weaknesses present in the preparation of financial
statements as a result of the departure of its Chief Financial Officer on May
16, 2007.





2.Segregation of Duties:We did not maintain
adequate segregation of duties related to job responsibilities for initiating,
authorizing, and recording of certain transactions.  Due to this
material weakness, there is a reasonable possibility that a material
misstatement in the financial statements would not be prevented or detected on a
timely basis.





Remediation
Efforts to Address Deficiencies in Internal Controls Over Financial
Reporting





As a
result of the findings of management’s assessment of our internal controls, the
Company intends to remediate this weakness by retaining full-time
accounting personnel, continuing to search for a replacement Chief Financial
Officer and the institution of additional internal reporting provisions and
controls.








Changes
in Internal Control Over Financial Reporting





Other
than as described above, there were no material changes in our internal control
over financial reporting (as defined in Rule 13a-15(f) under the Exchange
Act) that occurred as of June 30, 2008 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.





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Attestation
Report of the Independent Registered Public Accounting Firm





This
annual report does not include an attestation report of our registered public
accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by our registered public
accounting firm pursuant to temporary rules of the Securities and Exchange
Commission that permit us to provide only management’s report in this annual
report.








ITEM 9B  Other Information





Not
applicable





ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL
PERSONS, COMPLIANCE
WITH SECTION 16(A) OF THE EXCHANGE ACT





The
following table sets forth the names and ages of our current directors and
executive officers, their principal offices and positions and the date each such
person became a director or executive officer. Executive officers are elected
annually by our Board of Directors. Each executive officer holds his office
until he resigns, is removed by the Board or his successor is elected and
qualified. Directors are elected annually by our stockholders at the annual
meeting. Each director holds his office until his successor is elected and
qualified or his earlier resignation or removal.





The
following persons are the directors and executive officers of our
company:





Name
                  Age
                  TitleAnil
      Diwan, PhD.
                  50
                  President;
      Chairman of the BoardEugene
      Seymour, MD, MPH
                  67
                  Chief
      Executive Officer; Acting CFO;
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
67, 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 50, 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 AllExcel, 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 four patents, one issued and three
applied for, and has made intellectual property depositions of several
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).





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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-K.





ITEM 11. EXECUTIVE COMPENSATION





The
Company's executive compensation program for the named executive officers (NEOs)
is administered by the Board of Directors.





COMPENSATION
OBJECTIVES





We
believe that the compensation programs for the Company's NEOs should reflect the
Company's performance and the value created for the Company's stockholders. In
addition, the compensation programs should support the short-term and long-term
strategic goals and values of the Company, and should reward individual
contributions to the Company's success. Our compensation plans are consequently
designed to link individual rewards with Company's performance by applying
objective, quantitative factors including the Company's own business
performance and general economic factors. We also rely upon subjective,
qualitative factors such as technical expertise, leadership and management
skills, when structuring executive compensation in a manner consistent with our
compensation philosophy.





ELEMENTS
OF COMPENSATION





BASE
SALARY. All full time executives are paid a base salary. Base salaries for our
executives are established based on the scope of their responsibilities,
professional qualifications, academic background, and the other elements of the
executive's compensation, including stock-based compensation. However, at this
time current total annual compensation is not in line with comparable companies,
because our philosophy was to pay modest salaries with no bonus to conserve
capital resources for future company growth. Our intent is to set executives'
base salaries near the median of the range of salaries for executives in similar
positions with similar responsibilities at comparable companies, in line with
our compensation philosophy. Base salaries are reviewed annually, and may be
increased to align salaries with market levels after taking into account the
subjective evaluation described previously.





EQUITY
INCENTIVE COMPENSATION. We believe that long-term performance is achieved
through an ownership culture participated in by our executive officers through
the use of stock-based awards. Currently, we do not maintain any incentive
compensation plans based on pre-defined performance criteria. The Board of
Directors has the general authority, however, to award equity incentive
compensation, i.e. stock options, to our executive officers in such amounts and
on such terms as the committee determines in its sole discretion. The Board of
Directors does not have a determined formula for determining the number of
options available to be granted. The Board of Directors will review each
executive's individual performance and his or her contribution to our strategic
goals periodically. With the exception of stock options automatically granted in
accordance with the terms of the employment agreement with our executive
officers, our Board of Directors grants equity incentive compensation at times
when we do not have material non-public information to avoid timing issues and
the appearance that such awards are made


based on
any such information.





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DETERMINATION
OF COMPENSATION





The Board
of Directors makes independent decisions about all aspects of NEO compensation,
and takes into account compensation data and benchmarks for comparable positions
and companies in


different
applicable geographical areas.





The
Company's current executives’ compensation program as of the date of this report
has been at the same level since 2005. The program is simplistic and is less
structured than a more mature corporation. Two of our officers are founders or
co-founders of the Company and their ownership in the Company has driven their
philosophy to provide modest salaries and no annual bonus. The compensation
structure was set to retain capital resources in the Company to further
growth.





The
following table reflects all forms of compensation for the year ended June 30,
2008 and for the period from May 12, 2005 (date of inception) through June 30,
2008. 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
      CompensationName
      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
                                            
                                            2008
                                            
                                            $
                                            237,500
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            2,035
                                            
                                            
                                            
                                            125,000
                                            
                                            
                                            
                                            $
                                            -2007
                                            
                                            $
                                            200,000
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            6,208
                                            
                                            
                                            
                                            125,000
                                            
                                            
                                            
                                            $
                                            -2006
                                            
                                            $
                                            150,000
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            23,087
                                            
                                            
                                            
                                            250,000
                                            
                                            
                                            
                                            $
                                            -Anil
      Diwan,President,
      Director
                                            
                                            2008
                                            
                                            $
                                            243,107
                                            
                                            
                                            $
                                            
                                            
                                            
                                            $
                                            1,500
                                            
                                            
                                            $
                                            5,009
                                            
                                            
                                            
                                            333,334
                                            
                                            
                                            
                                            $
                                            -2007
                                            
                                            $
                                            200,000
                                            
                                            
                                            $
                                            
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            17,197
                                            
                                            
                                            
                                            333,333
                                            
                                            
                                            
                                            $
                                            -2006
                                            
                                            $
                                            150,000
                                            
                                            
                                            $
                                            211,000
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            41,144
                                            
                                            
                                            
                                            333,333Leo
      Ehrlich,
                                            
                                            2008
                                            
                                            $
                                            91,666
                                            
                                            
                                            $
                                            
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            
                                            -Former
      CFO*
                                            
                                            2007
                                            
                                            $
                                            150,000
                                            
                                            
                                            $
                                            
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            3,657
                                            
                                            
                                            
                                            125,0002006
                                            
                                            $
                                            150,000
                                            
                                            
                                            $
                                            
                                            
                                            
                                            $
                                            -
                                            
                                            
                                            $
                                            23,087
                                            
                                            
                                            
                                            250,000





*
            Deferred compensation paid in
      2008, accrued in 2007





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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS,
MANAGEMENT, AND RELATED
STOCKHOLDERS MATTERS.





The
following table sets forth information relating to the beneficial ownership of
the Company's common stock by those persons beneficially 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
June 30, 2008.








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
                    29.66.%Anil
      Diwan (3) (4)
                      135
      Wood Street
                      West
      Haven, CT 06516
                    11,000,000
                    9.23
      %Eugene
      Seymour (5)
                      135
      Wood Street
                      West
      Haven, Connecticut 06516
                    8,500,000
                    7.13%Leo
      Ehrlich (6)
                      135
      Wood Street
                      West
      Haven, Connecticut 06516
                    7,225,000
                    6.06
      %All
      Directors and Executive
                      Officers
      as a Group (3 persons) (7)
                    60,902,592
                    52.08%








(1)
            "Beneficial
      Owner" means having or sharing, directly or indirectly (i) voting power,
      which includes the power to vote or to direct the voting, or (ii)
      investment power, which includes the power to dispose or to direct the
      disposition, of shares of the common stock of an issuer. The definition of
      beneficial ownership includes shares, underlying options or warrants to
      purchase common stock, or other securities convertible into common stock,
      that currently are exercisable or convertible or that will become
      exercisable or convertible within 60 days. Unless otherwise indicated, the
      beneficial owner has sole voting and investment
  power.





(2)
            For
      each shareholder, the calculation of percentage of beneficial ownership is
      based upon 119,270,677 shares of Common Stock outstanding as of June 30
      2008, and shares of Common Stock subject to options, warrants and/or
      conversion rights held by the shareholder that are currently exercisable
      or exercisable within 60 days, which are deemed to be outstanding and to
      be beneficially owned by the shareholder holding such options, warrants,
      or conversion rights. The percentage ownership of any shareholder is
      determined by assuming that the shareholder has exercised all options,
      warrants and conversion rights to obtain additional securities and that no
      other shareholder has exercised such
  rights.





(3)
            Anil
      Diwan, President and Chairman of the Board of Directors. Includes
      10,000,000 shares of NanoViricides common stock held by Mr. Diwan and
      1,000,000 shares of NanoViricides common stock issuable upon exercise of
      options held by Mr. Diwan that are currently exercisable or will become
      exercisable within 60 days.





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(4)
            Anil
      Diwan, the Company’s President and Chairman, also serves as the CEO and
      Director of TheraCour Pharma Inc. and owns approximately 70% of the
      outstanding capital stock of TheraCour.  Anil Diwan has both
      investment and dispositive power over the Nanoviricides shares held by
      TheraCour Pharma, Inc.





(5)
            Eugene
      Seymour, Chief Executive Officer and Director. Includes 8,000,000
      shares of NanoViricides common stock held by Dr. Seymour and 500,000
      shares of NanoViricides common stock issuable upon exercise of options
      held by Dr. Seymour that are currently exercisable or will become
      exercisable within 60 days.





(6)
            Leo
      Ehrlich, formerly Chief Financial Officer and Director. Includes 4,850,000
      shares of NanoViricides common stock held by Mr. Ehrlich and includes
      2,000,000 shares of NanoViricides common stock held by the wife and
      children of Leo Ehrlich, and 375,000 shares of NanoViricides common stock
      issuable upon exercise of options held by Mr. Ehrlich that are currently
      exercisable.





(7)
            Includes
      35,370,000 shares of Common Stock indirectly owned by certain of the
      Executive Officers and Directors as a
group.








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 increased to $250,000 per year upon closing of a
financing to the Company as ofOctober 16, 2007. 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 exercisable into the Company’s common stock
at $0.10 per share:





£
            Dr.
      Anil Diwan received 1,000,000 options, 333,333 options vested upon
      execution of the employment agreement. Another 333,333 options vested on
      January 1, 2007. The remaining 333,334 options vested on January 1, 2008 .
      The options expire September 26,
2015.








£
            Dr.
      Eugene Seymour received 500,000 options, 250,000 options vested upon
      execution of the employment agreement. Another 125,000 options vested on
      January 1, 2007. The remaining 125,000 options vested on January 1, 2008
      The options expire September 26,
2015.








Leo
Ehrlich received 500,000 options, 250,000 options vested upon execution of the
employment agreement. 125,000 options vested on January 1, 2007 . The remaining
options (125,000 options)were cancelled upon Mr. Ehrlich’s resignation from the
Company on May 16, 2007. The options expire September 26, 2015.








The
employment agreement expired on September 26, 2008. The Company and two of the
executives have agreed to continue the executive compensation under the same
terms until a new agreement is put into effect.





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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 2008 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. For the year ended June 30, 2008, the SAB was granted
a total of 180,000 stock warrants exercisable into common shares at prices from
$ .37 to $ 1.48 per share.





ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND
DIRECTOR INDEPENDENCE




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 $2,086,979 since
inception through June 30, 2008; $746,309 and $617,007 or the years ended June
30, 2008 and 2007, respectively. No royalties are due or have been paid from
inception through June 30, 2008.




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
June 30, 2008, 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 70% of the outstanding capital stock of
TheraCour.





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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; all work
performed by KARD must have prior approval of the executive officers of
NanoViricides; and we retain all intellectual property resulting from the
services by KARD. 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, 2008, and 2007, were, $233,015 and $114,801 respectively, and $554,235
since inception.








ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES





Audit
Fees





The
aggregate fees for each of the last two years for professional services rendered
by the principal accountant for our audits of our annual financial statements
and interim reviews of our financial statements included in our fillings
with Securities and Exchange Commission on Form 10-K and 10-Qs or services that
are normally provided by the accountant in connection with statutory and
regulatory filings or engagements for those years
were approximately:





June
      30, 2008:
                    $
      177,000
                    Holtz
      Rubinstein Reminick LLPJune
      30, 2007:
                    $
      120,000
                    Holtz
      Rubinstein Reminick
LLP





Audit
Related Fees





The
aggregate fees in each of the last two years for the assurance and related
services provided by the principal accountant that are not reasonably related to
the performance of the audit or review of the Company's financial


statements
and are not reported in paragraph (1) were approximately:





June
      30, 2008:
                $
      11,000
                Holtz
      Rubinstein Reminick LLPJune
      30, 2007:
                $
      34,000
                Holtz
      Rubinstein Reminick LLP





We
incurred these fees in connection with registration statements and financing
transactions.





Tax
Fees





The
aggregate fees in each of the last two years for the professional services
rendered by the principal accountant for tax compliance, tax advice and tax
planning were approximately:





June
      30, 2008:
                $
      0
                Holtz
      Rubinstein Reminick LLPJune
      30, 2007:
                $
      0
                Holtz
      Rubinstein Reminick LLP








All Other
Fees





The
aggregate fees in each of the last two years for the products and services
provided by the principal accountant, other than the services reported in
paragraph (1) were approximately:





June
      30, 2008:
                $
      0
                Holtz
      Rubinstein Reminick LLPJune
      30, 2007:
                $
      0
                Holtz
      Rubinstein Reminick LLP





Pre-Approval
Policies





The Board
of Directors, which performs the equivalent functions of an audit committee,
currently does not have any pre-approval policies or procedures concerning
services performed by Holtz Rubinstein Reminick LLP.  All the services
performed by Holtz Rubinstein Reminick LLPthat are described above were
pre-approved by the Board of Directors.





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ITEM 15.  EXHIBITS





Exhibit
      No.
                
                Description3.1*
                
                Articles
      of Incorporation, as amended, of the Registrant3.2*
                
                By-laws
      of the Registrant4.1*
                
                Specimen
      Stock Certificate of the Registrant4.2*
                
                Series
      A Convertible Debenture4.3*
                
                Form
      of Warrant10.1*
                
                Share
      Exchange Agreement between NanoViricide, Inc. and the
      Registrant10.2*
                
                Employment
      Agreement Eugene Seymour10.3*
                
                Employment
      agreement Anil Diwan10.4*
                
                Employment
      agreement Leo Ehrlich10.5*
                
                Form
      of Scientific Advisory Board Agreement10.6*
                
                Amended
      License Agreement with TheraCour Pharma, Inc.10.7*
                
                Lease
      with landlord10.8*
                
                Form
      of First Subscription Agreement10.9*
                
                Form
      of Second Subscription Agreement10.10*
                
                Code
      of Ethics10.11*
                
                Amended
      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





*
Incorporated by reference to the Company’s registration statement on Form 10-SB,
filed with the Securities Commission on November 14, 2006, as
amended.




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SIGNATURES




Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.





Dated:
October 28, 2008





NANOVIRICIDES,
      INC./s/
      Eugene Seymour, MDEugene
      Seymour, M.D.Chief
      Executive and Interim Chief Financial Officer and
      Director/s/
      Anil DiwanAnil
      DiwanChief
      Executive Officer, President and Chairman of the Board of
      Directors




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NANOVIRICIDES,
INC.
 (A
DEVELOPMENT STAGE COMPANY)
 
 Index to Financial
Statements
 
 Report
      of Independent Registered Public Accounting FirmFinancial
      StatementsBalance
      Sheets – June 30, 2008 and 2007
                  F-2Statements
      of Operations – For the Years Ended June 30, 2008 and 2007 and For the
      Cumulative Period May 12, 2005 (Inception) through June 30,
      2008.
                  F-3Statements
      of Changes in Stockholders’ Equity (Deficit) – For the Cumulative Period
      May 12, 2005 (Inception) through June 30, 2008.
                  F-4Statements
      of Cash Flows – For the Years Ended June 30, 2008 and 2007 and For the
      Cumulative Period May 12, 2005 (Inception) through June 30,
      2008.
                  F-10Notes
      to Financial Statements
                  F-12
 Table of Contents
 REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
  
 
 To the
Board of Directors and
 Stockholders
of NanoViricides, Inc.
 
 We have
audited the accompanying balance sheets of NanoViricides, Inc. (a development
stage company, the “Company”) as of June 30, 2008 and 2007, and the related
statements of operations, stockholders’ equity, and cash flows for the years
ended June 30, 2008 and 2007 and the cumulative period from May 12, 2005 (date
of inception) through June 30, 2008. 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. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audits included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements and 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,
2008 and 2007, and the results of its operations and its cash flows for the
years ended June 30, 2008 and 2007 and the cumulative period from May 12, 2005
(date of inception) through June 30, 2008, 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 revenues, 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 this uncertainty.
 
 
 /s/ Holtz
Rubenstein Reminick LLP
 
 New York,
NY
 October
28, 2008
 Table of Contents
  NANOVIRICIDES,
INC.
 (A
DEVELOPMENT STAGE COMPANY)
 BALANCE
SHEETS
  June 30, 2008
                                                          
                                                          
                                                          June 30, 2007ASSETSCURRENT
      ASSETS:Cash
      and cash equivalents
                                                          
                                                          $
                                                          816,386
                                                          
                                                          
                                                          $
                                                          967,797Prepaid
      expenses
                                                          
                                                          
                                                          328,544
                                                          
                                                          
                                                          
                                                          251,722Other
      current assets
                                                          
                                                          
                                                          102,873
                                                          
                                                          
                                                          
                                                          5,000Total
      current assets
                                                          
                                                          
                                                          1,247,803
                                                          
                                                          
                                                          
                                                          1,224,519Property
      and equipment, net
                                                          
                                                          
                                                          133,738
                                                          
                                                          
                                                          
                                                          18,487OTHER
      ASSETS:Security
      deposit
                                                          
                                                          
                                                          80,000
                                                          
                                                          
                                                          
                                                          100,000Trademark,
      net
                                                          
                                                          
                                                          6,709
                                                          
                                                          
                                                          
                                                          7,215Total
      other assets
                                                          
                                                          
                                                          86,709
                                                          
                                                          
                                                          
                                                          107,215TOTAL
      ASSETS
                                                          
                                                          $
                                                          1,468,250
                                                          
                                                          
                                                          $
                                                          1,350,221LIABILITIES
      AND STOCKHOLDERS’ EQUITYCURRENT
      LIABILITIES:Accounts
      payable
                                                          
                                                          $
                                                          295,555
                                                          
                                                          
                                                          $
                                                          72,845Accounts
      payable – related parties
                                                          
                                                          
                                                          374,394
                                                          
                                                          
                                                          
                                                          262,038Accrued
      expenses
                                                          
                                                          
                                                          96,130
                                                          
                                                          
                                                          
                                                          65,000Accrued
      payroll  to officers and related payroll  tax
      expense
                                                          
                                                          
                                                          258,432
                                                          
                                                          
                                                          
                                                          450,000TOTAL
      CURRENT LIABILITIES
                                                          
                                                          
                                                          1,024,511
                                                          
                                                          
                                                          
                                                          849,883COMMITMENTS
      AND CONTINGENCIESSTOCKHOLDERS’
      EQUITYCommon
      stock, $0.001 par value; 300,000,000 shares authorized at June 30, 2008
      and 2007; issued and outstanding: 119,270,677 (2008) and
      114,069,144(2007)
                                                          
                                                          
                                                          119,271
                                                          
                                                          
                                                          
                                                          114,069Additional
      paid-in capital
                                                          
                                                          
                                                          9,532,205
                                                          
                                                          
                                                          
                                                          6,855,689Stock
      subscription receivable
                                                          
                                                          
                                                          -
                                                          
                                                          
                                                          
                                                          (20
                                                          )Deficit
      accumulated during the development stage
                                                          
                                                          
                                                          (9,207,737
                                                          )
                                                          
                                                          
                                                          (6,469,400
                                                          )TOTAL
      STOCKHOLDERS’ EQUITY
                                                          
                                                          
                                                          443,739
                                                          
                                                          
                                                          
                                                          500,338TOTAL
      LIABILITIES AND STOCKHOLDERS’ EQUITY
                                                          
                                                          $
                                                          1,468,250
                                                          
                                                          
                                                          $
                                                          1,350,221
 The
accompanying notes are an integral part of these financial
statements.
  F -
2
 Table of Contents
  NANOVIRICIDES,
INC.
 (A
DEVELOPMENT STAGE COMPANY)
 STATEMENTS
OF OPERATIONS
  Year
      Ended
                                        June
      30,2008
                                      
                                      
                                      Year Ended
                                        June
      30,2007
                                      
                                      
                                      For
      the Cumulative Period
                                        From
                                        May
      12. 2005 (Inception)
                                        Through
                                        June
      30, 2008Revenues
                                      
                                      $
                                      -
                                      
                                      
                                      $
                                      -
                                      
                                      
                                      $
                                      -Operating
      expenses:Research
      and development
                                      
                                      
                                      1,039,427
                                      
                                      
                                      
                                      731,808
                                      
                                      
                                      
                                      2,701,897Refund
      Credit for research and development costs
                                      
                                      
                                      (200,190
                                      )
                                      
                                      
                                      -
                                      
                                      
                                      
                                      (200,190
                                      )General
      and administrative (of this amount $181,718, $453,201 and $1,062,623 was
      for stock and option based compensation to consultants and
      officers)
                                      
                                      
                                      1,952,804
                                      
                                      
                                      
                                      2,351,104
                                      
                                      
                                      
                                      6,035,099Total
      operating expenses
                                      
                                      
                                      2,792,041
                                      
                                      
                                      
                                      3,082,912
                                      
                                      
                                      
                                      8,536,806Loss
      from operations
                                      
                                      
                                      (2,792,041
                                      )
                                      
                                      
                                      (3,082,912
                                      )
                                      
                                      
                                      (8,536,806
                                      )Other
      income (expenses)Interest
      income, net
                                      
                                      
                                      53,704
                                      
                                      
                                      
                                      54,511
                                      
                                      
                                      
                                      116,078Non
      cash interest on convertible debentures
                                      
                                      
                                      -
                                      
                                      
                                      
                                      (7,644
                                      )
                                      
                                      
                                      (73,930
                                      )Non
      cash interest expense on beneficial conversion feature of convertible
      debentures
                                      
                                      
                                      -
                                      
                                      
                                      
                                      (82,918
                                      )
                                      
                                      
                                      (713,079
                                      )Total
      other income ( expenses)
                                      
                                      
                                      53,704
                                      
                                      
                                      
                                      (36,051
                                      )
                                      
                                      
                                      (670,931
                                      )Net
      loss to common stockholders
                                      
                                      $
                                      (2,738,337
                                      )
                                      
                                      $
                                      (3,118,963
                                      )
                                      
                                      $
                                      (9,207,737
                                      )Net
      loss per share: basic and diluted$
                                      (0.02
                                      )
                                      
                                      $
                                      (0.03
                                      )Weighted
      average shares outstanding: basic and diluted
                                      
                                      
                                      117,098,514
                                      
                                      
                                      
                                      112,255,669


The
accompanying notes are an integral part of these financial
statements.


F -
3
 Table of Contents




NANOVIRICIDES,
INC.


(A
DEVELOPMENT STAGE COMPANY)


STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT)


FOR
THE CUMULATIVE PERIOD MAY 12, 2005 (INCEPTION) THROUGH JUNE 30,
2008





Common
      StockNumber
                      of
      Shares
                    
                    
                    Par
                      Value
                    
                    
                    Additional
                      Paid-in
                      Capital
                    
                    
                    Stock
                      Subscription
                      Receivable
                    
                    
                    Accumulated
                      Deficit
                    
                    
                    Total
                      Shareholders'
                      EquityShares
      issued May 12, 2005 (Inception)
                    
                    
                    20,000
                    
                    
                    $
                    20
                    
                    
                    $
                    -
                    
                    
                    $
                    (20
                    )
                    
                    $
                    -
                    
                    
                    $
                    -Share
      exchange with Edot-com.com Inc., June 1, 2005
                    
                    
                    (20,000
                    )
                    
                    
                    (20
                    )
                    
                    
                    -
                    
                    
                    
                    20
                    
                    
                    
                    -
                    
                    
                    
                    -Shares
      exchanged in reverse acquisition of Edot-com.com Inc., June 1,
      2005
                    
                    
                    80,000,000
                    
                    
                    
                    80,000
                    
                    
                    
                    (79,980
                    )
                    
                    
                    (20
                    )
                    
                    
                    -
                    
                    
                    
                    -Shares
      outstanding Edot-com.com Inc., June 1, 2005
                    
                    
                    20,000,000
                    
                    
                    
                    20,000
                    
                    
                    
                    (20,000
                    )
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    -Net
      loss period ended June 30, 2005
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    (66,005
                    )
                    
                    
                    (66,005
                    )Balance
      at June 30, 2005 (as restated)
                    
                    
                    100,000,000
                    
                    
                    
                    100,000
                    
                    
                    
                    (99,980
                    )
                    
                    
                    (20
                    )
                    
                    
                    (66,005
                    )
                    
                    
                    (66,005
                    )Discount
      related to beneficial conversion feature of Convertible debentures, July
      13, 2005
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    5,277
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    5,277Legal
      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
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    5,302Warrants
      issued to Scientific Advisory Board, August 15, 2005
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    4,094
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    4,094Options
      issued to officers, September 23, 2005
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    87,318
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    87,318Shares
      issued for consulting services rendered at $.081 per share, September 30,
      2005
                    
                    
                    2,300,000
                    
                    
                    
                    2,300
                    
                    
                    
                    184,000
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    186,300Shares
      issued for interest on debentures, September 30, 2005
                    
                    
                    48,177
                    
                    
                    
                    48
                    
                    
                    
                    4,267
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    4,315Discount
      related to beneficial conversion feature of Convertible debentures,
      October 28, 2005
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    166,666
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    166,666Discount
      related to beneficial conversion feature of Convertible debentures,
      November 9, 2005
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    166,667
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    166,667


F -
4
 Table of Contents





Common
      StockNumber
                    of
      Shares
                  
                  
                  Par
                    Value
                  
                  
                  Additional
                    Paid-in
                    Capital
                  
                  
                  Stock
                    Subscription
                    Receivable
                  
                  
                  Accumulated
                    Deficit
                  
                  
                  Total
                    Stockholders'
                    EquityDiscount
      related to beneficial conversion feature of Convertible debentures,
      November 10, 2005
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  45,000
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  45,000Discount
      related to beneficial conversion feature of Convertible debentures,
      November 11, 2005
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  275,000
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  275,000Discount
      related to beneficial conversion feature of Convertible debentures,
      November 15, 2005
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  49,167
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  49,167Warrants
      issued to Scientific Advisory Board, November 15, 2005
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  25,876
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  25,876Shares
      and warrants issued in connection with private placement of common stock,
      November 28, 2005
                  
                  
                  340,000
                  
                  
                  
                  340
                  
                  
                  
                  169,660
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  170,000Shares
      and warrants issued in connection with private placement of common stock,
      November 29, 2005
                  
                  
                  300,000
                  
                  
                  
                  300
                  
                  
                  
                  149,700
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  150,000Shares
      and warrants issued in connection with private placement of common stock,
      November 30, 2005
                  
                  
                  150,000
                  
                  
                  
                  150
                  
                  
                  
                  74,850
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  75,000Shares
      and warrants issued in connection with private placement of common stock,
      December 2, 2005
                  
                  
                  100,000
                  
                  
                  
                  100
                  
                  
                  
                  49,900
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  50,000Shares
      and warrants issued in connection with private placement of common stock,
      December 6, 2005
                  
                  
                  850,000
                  
                  
                  
                  850
                  
                  
                  
                  424,150
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  425,000


F -
5
 Table of Contents




Common
      StockNumber
                      of
      Shares
                    
                    
                    Par
                      Value
                    
                    
                    Additional
                      Paid-in
                      Capital
                    
                    
                    Stock
                      Subscription
                      Receivable
                    
                    
                    Accumulated
                      Deficit
                    
                    
                    Total
                      Stockholders’
                      EquityShares
      issued for legal services rendered at $.95 per share, December 6,
      2005
                    
                    
                    20,000
                    
                    
                    
                    20
                    
                    
                    
                    18,980
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    19,000Shares
      and warrants issued in connection with private placement of common stock,
      December 12, 2005
                    
                    
                    750,000
                    
                    
                    
                    750
                    
                    
                    
                    374,250
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    375,000Shares
      and warrants issued in connection with private placement of common stock,
      December 13, 2005
                    
                    
                    50,000
                    
                    
                    
                    50
                    
                    
                    
                    24,950
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    25,000Shares
      and warrants issued in connection with private placement of common stock,
      December 14, 2005
                    
                    
                    50,000
                    
                    
                    
                    50
                    
                    
                    
                    24,950
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    25,000Shares
      issued in connection with debenture offering, December 15,
      2005
                    
                    
                    50,000
                    
                    
                    
                    50
                    
                    
                    
                    48,950
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    49,000Shares
      and warrants issued in connection with private placement of common stock,
      December 20, 2005
                    
                    
                    50,000
                    
                    
                    
                    50
                    
                    
                    
                    24,950
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    25,000Shares
      and warrants issued in connection with private placement of common stock,
      December 29, 2005
                    
                    
                    50,000
                    
                    
                    
                    50
                    
                    
                    
                    24,950
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    25,000Shares
      and warrants issued in connection with private placement of common stock,
      December 30, 2005.
                    
                    
                    50,000
                    
                    
                    
                    50
                    
                    
                    
                    24,950
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    25,000Shares
      issued for interest on debentures, December 31, 2005
                    
                    
                    19,476
                    
                    
                    
                    19
                    
                    
                    
                    17,321
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    17,340Shares
      issued for consulting services rendered at $1.46 per share, January 9,
      2006
                    
                    
                    3,425
                    
                    
                    
                    4
                    
                    
                    
                    4,997
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    5,001Warrants
      issued to Scientific Advisory Board on February 15, 2006
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    49,067
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    49,067Warrants
      issued to Scientific Advisory Board on May 15, 2006
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    51,048
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    51,048Shares
      issued for interest on debentures, March 31, 2005
                    
                    
                    7,921
                    
                    
                    
                    8
                    
                    
                    
                    22,184
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    22,192Options
      exercised, May 31, 2006
                    
                    
                    1,800,000
                    
                    
                    
                    1,800
                    
                    
                    
                    88,200
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    90,000


F -
6
 Table of Contents




Common
      StockNumber
                          of
      Shares
                        
                        
                        Par
                          Value
                        
                        
                        Additional
                          Paid-in
                          Capital
                        
                        
                        Stock
                          Subscription
                          Receivable
                        
                        
                        Accumulated
                          Deficit
                        
                        
                        Total
                          Stockholders’
                          EquityShares
      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
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        22,438Net
      loss year ended June 30, 2006.
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        (3,284,432
                        )
                        
                        
                        (3,284,432
                        )Balance
      at June 30, 2006 (as restated)
                        
                        
                        108,878,425
                        
                        
                        $
                        108,878
                        
                        
                        $
                        4,480,035
                        
                        
                        $
                        (20
                        )
                        
                        $
                        (3,350,437
                        )
                        
                        $
                        1,238,456Shares
      issued for interest on debentures, July 31, 2006
                        
                        
                        5,744
                        
                        
                        
                        6
                        
                        
                        
                        7,638
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        7,644Shares
      issued in connection with conversion of convertible debentures, July 31,
      2006
                        
                        
                        3,333,333
                        
                        
                        
                        3,333
                        
                        
                        
                        996,667
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        1,000,000Exercise
      of stock warrants, July 31, 2006
                        
                        
                        200,000
                        
                        
                        
                        200
                        
                        
                        
                        49,800
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        50,000Warrants
      issued to Scientific Advisory Board on August 15, 2006
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        30,184
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        30,184Warrants
      issued to Scientific Advisory Board on November 15, 2006
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        25,888
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        25,888Shares
      issued for consulting and legal services rendered at $.76 per share,
      January 2, 2007
                        
                        
                        216,000
                        
                        
                        
                        216
                        
                        
                        
                        163,944
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        164,160Warrants
      issued to Scientific Advisory Board on February 15, 2007
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        32,668
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        32,668Warrants
      issued to Scientific Advisory Board on May 15, 2007
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        25,664
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        25,664Shares
      issued for consulting services rendered at $1.03 per share, June 12,
      2007
                        
                        
                        752
                        
                        
                        
                        1
                        
                        
                        
                        774
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        775Shares
      issued for consulting services rendered at $1.15 per share, June 20,
      2007
                        
                        
                        100,000
                        
                        
                        
                        100
                        
                        
                        
                        114,900
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        115,000Shares
      issued upon conversion of convertible warrants  at $1.00 per
      share, June 20, 2007
                        
                        
                        930,000
                        
                        
                        
                        930
                        
                        
                        
                        619,070
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        620,000


F -
7
 Table of Contents




Common
      StockNumber
                          of
      Shares
                        
                        
                        Par
                          Value
                        
                        
                        Additional
                          Paid-in
                          Capital
                        
                        
                        Stock
                          Subscription
                          Receivable
                        
                        
                        Accumulated
                          Deficit
                        
                        
                        Total
                          Stockholders’
                          EquityShares
      issued upon conversion of convertible warrants  at $1.00 per
      share, June 25, 2007
                        
                        
                        75,000
                        
                        
                        
                        75
                        
                        
                        
                        49,925
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        50,000Shares
      issued upon conversion of convertible warrants  at $1.00 per
      share, June 30, 2007
                        
                        
                        300,000
                        
                        
                        
                        300
                        
                        
                        
                        199,700
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        200,000Shares
      issued for consulting and legal services rendered at $1.06 per share, June
      30, 2007
                        
                        
                        29,890
                        
                        
                        
                        30
                        
                        
                        
                        31,770
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        31,800Options
      issued to officers June 30, 2007
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        27,062
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        27,062Net
      loss year ended June 30, 2007.
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        (3,118,963
                        )
                        
                        
                        (3,118,963
                        )Balance
      at June 30, 2007
                        
                        
                        114,069,144
                        
                        
                        $
                        114,069
                        
                        
                        $
                        6,855,689
                        
                        
                        $
                        (20
                        )
                        
                        $
                        (6,469,400
                        )
                        
                        $
                        500,338Warrants
      issued to Scientific Advisory Board on August 15, 2007
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        14,800
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        14,800Shares
      and warrants issued in connection with private placement of common stock,
      September 21, 2007
                        
                        
                        1,500,000
                        
                        
                        
                        1,500
                        
                        
                        
                        748,500
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        750,000Shares
      issued for consulting and legal  services rendered at $.75 per
      share September 30,  2007
                        
                        
                        25,244
                        
                        
                        
                        25
                        
                        
                        
                        18,375
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        18,400Shares
      and warrants issued in connection with private placement of common stock,
      October 16,  2007
                        
                        
                        3,250,000
                        
                        
                        
                        3,250
                        
                        
                        
                        1,621,750
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        1,625,000Shares
      and warrants issued in connection with private placement of common stock,
      October 16, 2007
                        
                        
                        250,000
                        
                        
                        
                        250
                        
                        
                        
                        124,750
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        125,000Warrants
      issued to Scientific Advisory Board on November 15, 2007
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        7,200
                        
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        7,200


F -
8
 Table of Contents




Common
      StockNumber
                      of
      Shares
                    
                    
                    Par
                      Value
                    
                    
                    Additional
                      Paid-in
                      Capital
                    
                    
                    Stock
                      Subscription
                      Receivable
                    
                    
                    Accumulated
                      Deficit
                    
                    
                    Total
                      Stockholders’
                      EquityShares
      issued for consulting and legal services rendered at $.49 per share
      December 31, 2007
                    
                    
                    57,152
                    
                    
                    
                    57
                    
                    
                    
                    26,843
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    26,900Options
      issued to officers January 1, 2008
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    7,044
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    7,044Warrants
      issued to Scientific Advisory Board on February 15, 2008
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    8,500
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    8,500Shares
      issued for consulting and legal services rendered at $ .45 per share March
      31, 2008
                    
                    
                    61,546
                    
                    
                    
                    62
                    
                    
                    
                    27,838
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    27,900Shares
      issued for consulting services rendered at $.39 per share April ,
      2008
                    
                    
                    27,750
                    
                    
                    
                    28
                    
                    
                    
                    10,793
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    10,821Warrants
      issued to Scientific Advisory Board on May 15, 2008
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    32,253
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    32,253Shares
      issued for consulting services rendered at $1.03 per share June 30,
      2008
                    
                    
                    29,841
                    
                    
                    
                    30
                    
                    
                    
                    27,870
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    27,900Stock
      subscriptions received
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    20
                    
                    
                    
                    -
                    
                    
                    
                    20Net
      loss year ended June 30, 2008.
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    (2,738,337
                    )
                    
                    
                    (2,738,337
                    )Balance
      at June 30, 2008
                    
                    
                    119,270,677
                    
                    
                    $
                    119,271
                    
                    
                    $
                    9,532,205
                    
                    
                    $
                    -
                    
                    
                    $
                    (9,207,737
                    )
                    
                    $
                    443,739








The
accompanying notes are an integral part of these financial
statements.


F -
9
 Table of Contents




NANOVIRICIDES,
INC.


(A
DEVELOPMENT STAGE COMPANY)


STATEMENTS
OF CASH FLOWS




Year
      Ended
                                                              June
      30, 2008
                                                            
                                                            
                                                            Year
      Ended
                                                              June
      30, 2007
                                                            
                                                            
                                                            For
      the Cumulative Period
                                                              From
      May 12, 2005 (Inception) through
                                                              June
      30, 2008OPERATING
      ACTIVITIES:Net
      loss
                                                            
                                                            $
                                                            (2,738,337
                                                            )
                                                            
                                                            $
                                                            (3,118,963
                                                            )
                                                            
                                                            $
                                                            (9,207,737
                                                            )Adjustments
      to reconcile net loss to net cash used by operating
      activities:Shares
      issued for services rendered
                                                            
                                                            
                                                            111,921
                                                            
                                                            
                                                            
                                                            311,735
                                                            
                                                            
                                                            
                                                            633,957Warrants
      granted to scientific advisory board
                                                            
                                                            
                                                            62,753
                                                            
                                                            
                                                            
                                                            114,404
                                                            
                                                            
                                                            
                                                            307,241Amortization
      of deferred compensation
                                                            
                                                            
                                                            7,044
                                                            
                                                            
                                                            
                                                            27,062
                                                            
                                                            
                                                            
                                                            121,424Depreciation
      and amortization
                                                            
                                                            
                                                            6,428
                                                            
                                                            
                                                            
                                                            2,525
                                                            
                                                            
                                                            
                                                            9,047Amortization
      of deferred financing expenses
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            6,714
                                                            
                                                            
                                                            
                                                            51,175Non
      cash interest on convertible debentures
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            7,644
                                                            
                                                            
                                                            
                                                            73,930Non
      cash interest expense on beneficial conversion feature of convertible
      debentures
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            82,918
                                                            
                                                            
                                                            
                                                            713,079Changes
      in assets and liabilities:Prepaid
      expenses
                                                            
                                                            
                                                            (76,822
                                                            )
                                                            
                                                            
                                                            (
      22,994
                                                            )
      )
                                                            
                                                            
                                                            (328,544
                                                            )Other
      current assets
                                                            
                                                            
                                                            (97,873
                                                            )
                                                            
                                                            
                                                            (20,000
                                                            )
                                                            
                                                            
                                                            (102,873
                                                            )Deferred
      expenses
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            (2,175
                                                            )Accounts
      payable-trade
                                                            
                                                            
                                                            222,710
                                                            
                                                            
                                                            
                                                            28,769
                                                            
                                                            
                                                            
                                                            295,555Accounts
      payable – related parties
                                                            
                                                            
                                                            112,356
                                                            
                                                            
                                                            
                                                            58,993
                                                            
                                                            
                                                            
                                                            374,394Accrued
      expenses
                                                            
                                                            
                                                            31,130
                                                            
                                                            
                                                            
                                                            (25,831
                                                            )
                                                            
                                                            
                                                            96,130Accrued
      payroll to officers and related payroll tax expense
                                                            
                                                            
                                                            (191,568
                                                            )
                                                            
                                                            
                                                            217,718
                                                            
                                                            
                                                            
                                                            258,432Other
      payroll taxes payable
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            (3,826
                                                            )
                                                            
                                                            
                                                            -Net
      cash used in operating activities
                                                            
                                                            
                                                            (2,550,258
                                                            )
                                                            
                                                            
                                                            (2,333,132
                                                            )
      )
                                                            
                                                            
                                                            (6,706,965
                                                            )INVESTING
      ACTIVITIES:Secuity
      deposit
                                                            
                                                            
                                                            20,000
                                                            
                                                            
                                                            
                                                            (100,000
                                                            )
                                                            
                                                            
                                                            (
      80,000
                                                            )Purchases
      of property and equipment
                                                            
                                                            
                                                            (121,173
                                                            )
                                                            
                                                            
                                                            (18,586
                                                            )
                                                            
                                                            
                                                            (141,907
                                                            )Purchase
      of  Trademark
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            (7,587
                                                            )
                                                            
                                                            
                                                            (7,587
                                                            )Net
      cash used in investing activities
                                                            
                                                            
                                                            (101,173
                                                            )
                                                            
                                                            
                                                            (126,173
                                                            )
      )
                                                            
                                                            
                                                            (229,494
                                                            )FINANCING ACTIVITIES:Proceeds
      from issuance of convertible debentures
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            1,000,000Proceeds
      from issuance of common stock in connection with the private placement of
      common stock, net of fees
                                                            
                                                            
                                                            2,500,000
                                                            
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            5,742,825Proceeds
      from stock option exercise
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            90,000Proceeds
      from exercise of warrants
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            920,000
                                                            
                                                            
                                                            
                                                            920,000Stock
      subscription received
                                                            
                                                            
                                                            20
                                                            
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            20Net
      cash provided by financing activities
                                                            
                                                            
                                                            2,500,020
                                                            
                                                            
                                                            
                                                            920,000
                                                            
                                                            
                                                            
                                                            7,752,845NET
      INCREASE IN CASH AND CASH EQUIVALENTS
                                                            
                                                            
                                                            (151,411
                                                            )
                                                            
                                                            
                                                            (1,539,305
                                                            )
                                                            
                                                            
                                                            816,386CASH
      AND CASH EQUIVALENTS, BEGINNING
                                                            
                                                            
                                                            967,797
                                                            
                                                            
                                                            $
                                                            2,507,102
                                                            
                                                            
                                                            
                                                            -CASH
      AND CASH EQUIVALENT, ENDING
                                                            
                                                            $
                                                            816,386
                                                            
                                                            
                                                            $
                                                            967,797
                                                            
                                                            
                                                            $
                                                            816,386CASH
      PAID DURING THE YEAR FOR:INTEREST
                                                            
                                                            $
                                                            -
                                                            
                                                            
                                                            $
                                                            -
                                                            
                                                            
                                                            $
                                                            -INCOME
      TAXES
                                                            
                                                            $
                                                            970
                                                            
                                                            
                                                            $
                                                            2,067
                                                            
                                                            
                                                            $
                                                            2,067


The
accompanying notes are an integral part of these financial
statements.


F -
10
 Table of Contents




NANOVIRICIDES,
INC.


(A
DEVELOPMENT STAGE COMPANY)


STATEMENTS
OF CASH FLOWS (CONTINUED)





SUPPLEMENTAL
DISCLOSURE OF NON-CASH ACTIVITY





During
the periods indicated below, the Company had the following non-cash
activity:






Year Ended June 30,2008
                    
                    
                    2007
                    
                    
                    For
      the Cumulative Period From May 12, 2005 (Inception) through June 30,
      2008Common
      stock issued for services rendered
                    
                    $
                    111,921
                    
                    
                    $
                    311,735
                    
                    
                    $
                    633,957Stock
      options issued to the officers as compensation
                    
                    
                    7,044
                    
                    
                    
                    27,062
                    
                    
                    
                    121,424Stock
      warrants granted to scientific advisory board
                    
                    
                    62,753
                    
                    
                    
                    114,404
                    
                    
                    
                    307,241Common
      stock issued for interest on debentures
                    
                    
                    -
                    
                    
                    
                    7,644
                    
                    
                    
                    73,930Shares
      of common stock issued in connection with debenture
    offering
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    49,000Warrants
      issued in connection with private placement
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    1,262,632Common
      stock issued upon conversion of convertible debentures
                    
                    
                    -
                    
                    
                    
                    1,000,000
                    
                    
                    
                    1,000,000Debt
      discount related to beneficial conversion feature of convertible
      debt
                    
                    
                    -
                    
                    
                    
                    82,918
                    
                    
                    
                    713,079








The
accompanying notes are an integral part of these financial
statements.


F -
11
 Table of Contents


NANOVIRICIDES,
INC


(A
DEVELOPMENT STAGE COMPANY)


NOTES
TO FINANCIAL STATEMENTS


JUNE
30, 2008 AND 2007





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. TheraCour has granted us the right to
include dengue fever among the viruses we are able to treat.  However,
no written agreement has been entered into with TheraCour and no assurance can
be given that a written amendment to the licensing agreement with TheraCour will
ever be reached or that, if reached, will be on terms favorable to the
Company.





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
2 - Substantial Doubt Regarding Ability to Continue as a Going
Concern





The
Company’s financial statements at June 30, 2008 and for the year then ended have
been prepared on a going concern basis, which contemplates the realization of
assets and settlement of liabilities and commitments in the normal course of
business.  The Company incurred a loss of $9,207,737 for the period
from May 12, 2005 (date of inception) through June 30, 2008.  In
addition, the Company has not generated any revenues and no revenues are
anticipated.  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.  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 private financings (See Notes 8 and 9) and a cash and
cash equivalent balance of $816,386 at June 30, 2008, substantial additional
financing will be required in future periods, as the Company believes it will
require in excess of $3,000,000 to fund its operations during the next twelve
months.  These conditions raise substantial doubt as to the Company’s
ability to continue as a going concern.


F -
12
 Table of Contents


Management’s
plan to support the Company in operation and to maintain its business strategy
is to raise funds through public and private offerings and to rely on officers
and directors to perform essential functions with minimal
compensation.  If the Company does not raise all of the money it needs
from its public and private offerings, it will have to find alternative sources,
such as a secondary public offering, a private placement of securities, or loans
from its officers, directors, or others.  If the Company requires
additional cash and cannot raise it, it will either have to suspend operations
until the cash is raised or cease business entirely.





The
accompanying financial statements do not include any adjustments related to the
recoverability and classification of assets or the amounts and classifications
of liabilities that might be necessary should the Company be unable to continue
as a going concern.





On August
22, 2008, the Company raised $3,286,000 from the sale of stock and “Warrants.”
This private placement of stock included 150,000 shares of Common Stock and
75,000 Warrants subscribed in consideration of $150,000 worth of scientific
testing performed for the Company.  Also on August 22, 2008, the
Company consummated subscriptions with its Warrants holders, thereby raising an
additional $106,250.  See Note 13. Subsequent Event.





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
      operations 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.
      Cash and cash equivalents is comprised of cash and money market funds and
      stated at cost, which approximates fair value. In addition, the Company
      maintains cash and cash equivalents at financial institutions, which may
      exceed federally insured amounts at
times.





C.
            Property and Equipment –
      Property and equipment is stated at cost and depreciated over the
      estimated useful lives of the assets (generally five years), or lease
      term, using the straight-line
method.





D.
            Use of Estimates – The
      preparation of financial statements in conformity with accounting
      principles generally accepted in the United States of America requires
      management to make estimates and assumptions that affect the reported
      amounts of assets and liabilities and disclosure of contingent assets and
      liabilities at the date of the financial statements and the reported
      amounts of revenues and expenses during the reporting period. Actual
      results could differ from those
estimates.





E.
            Research and Development
      – Research and development expenses consist primarily of costs associated
      with the preclinical and or clinical trials of drug candidates,
      compensation and other expenses for research and development, personnel,
      supplies and development materials, costs for consultants and related
      contract research and facility costs. Expenditures relating to research
      and development are expensed as
incurred.





F.
            Accounting for Stock Based
      Compensation – The Company adopted the fair value recognition
      provisions of “FASB Statement No. 123(R) Share-Based Payment”, using the
      modified prospective-transition method. Under that transition method,
      compensation cost recognized in the years ended June 30, 2007 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).





G.
            Accounting for Non-Employee
      Stock Based Compensation – The Company accounts for shares and
      options issued for non-employees in accordance with the provision of
      Emerging Issue Task Force Issue No. 96-18, “Accounting for Equity
      Instruments that are issued to other than Employees for Acquiring or in
      Conjunction with selling Goods or Services”. According to the provisions
      of ETIF 96-18, the Company determines the fair value of stock and options
      granted to non-employees on the measurement date which is either the date
      of a commitment for performance has been reached or when performance has
      been completed, depending upon the facts and circumstances. The fair value
      of the shares and options valued at commitment date is expensed
      immediately if they were for past
services.


F -
13
 Table of Contents




H.
            Income Taxes – The
      Company utilizes Statement of Financial Accounting Standards No. 109,
      “Accounting for Income Taxes,” which requires an asset and liability
      approach to financial accounting and reporting for income taxes. The
      difference between the financial statement and tax basis of assets and
      liabilities is determined annually. Deferred income tax assets and
      liabilities are computed for those temporary differences that have future
      tax consequences using the current enacted tax laws and rates that apply
      to the periods in which they are expected to affect taxable income.
      Valuation allowances are established, if necessary, to reduce the deferred
      tax asset to the amount that will, more likely than not, be realized.
      Income tax expense is the current tax payable or refundable for the year
      plus or minus the net change in the deferred tax assets and
      liabilities.





I.
            Basic Earnings (Loss) per
      Share – Basic Earnings (Loss) per Share is calculated in accordance
      with SFAS No. 128, "Earnings per Share," by dividing income or loss
      attributable to common stockholders by the weighted average common stock
      outstanding. Diluted EPS is calculated in accordance with SFAS No. 128 by
      adjusting weighted average common shares outstanding by assuming
      conversion of all potentially dilutive shares. In periods where a net loss
      is recorded, no effect is given to potentially dilutive securities, since
      the effect would be antidilutive. Total stock options and warrants not
      included in the calculation of common shares outstanding (including both
      exercisable and nonexercisable) as of June 30, 2008 and 2007 were
      6,250,000 and 4,570,000
respectively.





The
following table presents the calculation of basic and diluted net loss per
share:




2008
                        
                        
                        2007Net
      loss available to common shareholders
                        
                        $
                        (
      2,738,337
                        )
                        
                        $
                        (3,118,963
                        )Net
      loss per share, basic and diluted
                        
                        $
                        (0.02
                        )
                        
                        $
                        (0.03
                        )Weighted-average
      shares used in computing net loss per share, basic and
      diluted
                        
                        
                        117,098,514
                        
                        
                        
                        112,255,669


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, 2008 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.
            Fair Value of Financial
      Instruments





The
Company’s financial instruments include cash, cash equivalent, accounts payable,
receivables due from and payables due to related or affiliated parties, and
accrued liabilities. The carrying amounts on the Company’s financial statements
approximate their fair value.





M.
            New Accounting Pronouncements
      Affecting the Company








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 as required
under other accounting pronouncements. SFAS No. 157 is effective for financial
statements beginning with fiscal year beginning after November 15,2007, and
interim periods within those fiscal years. In Februaary, 2008, the FASB issued
FASB Staff position No. FAS 157-1 (FSP FAS 157-1) which excludes SFAS No. 13,
from the scope of SFAS 157.  In February 2008, the FASB issued FASB
Staff Position No.157-2 (FSP 157-2) which provides a one year delayed
application of SFAS 157 for non financial assets and liabilities, exceptfor
itemsthat are recognized  or disclosed at fair value in the financial
statements on a recurring basis ( at least annually). We are required to adopt
SFAS 157 as amended by FSP FAS 157-1 and FSP FAS 157-2 On July 1, 2008 The
Company is in the process of assessing the effect SFAS No. 157 may have on its
financial statements. .The adoption is not
expected  to have a material impact on our financial statements
..


F -
14
 Table of Contents




In
February 2007, the FASB issued SFAS No. 159, "Establishing the Fair Value Option
for Financial Assets and Liabilities" ("SFAS 159") to permit all entities to
choose to elect to measure eligible financial instruments and certain other
items at fair value. The decision whether to elect the fair value option may
occur for each eligible item either on a specified election date or according to
a preexisting policy for specified types of eligible items. However, that
decision must also take place on a date on which criteria under SFAS 159 occurs.
Finally, the decision to elect the fair value option shall be made on an
instrument-by-instrument basis, except in certain circumstances. An entity shall
report unrealized gains and losses on items for which the fair value option has
been elected in earnings at each subsequent reporting date. SFAS 159 applies to
fiscal years beginning after November 15, 2007. The Company is currently
evaluating this pronouncement.




In June
2007, the FASB ratified the consensus reached by the EITF on Issue No. 07-3
(EITF 07-3), Accounting for Nonrefundable Advance Payments for Goods or Services
Received for Use in Future Research and Development Activities. Pursuant to EITF
07-3, nonrefundable advance payments for goods or services that will be used or
rendered for future research and development activities should be deferred and
capitalized. Such amounts should be recognized as an expense when the related
goods are delivered or services are performed, or when the goods or services are
no longer expected to be received. This Issue is effective for us beginning July
1, 2008, and is to be applied prospectively for contracts entered into on or
after the effective date. We do not anticipate the implementation of this Issue
to be material to our financial position or results of operations.
 
 In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force (ETIF) on Issue No. 07-1 (EITF 07-1), Accounting for Collaborative
Arrangements. EITF 07-1 defines collaborative arrangements and establishes
reporting requirements for transactions between participants in a collaborative
arrangement and between participants in the arrangement and third parties. This
Issue is effective for us beginning July 1, 2009 and will be applied
retrospectively to all prior periods presented for all collaborative
arrangements existing as of the effective date. While we have not yet completed
our analysis, we don not anticipate the implementation of this Issue to be
material to our consolidated financial position or results of
operations.




In March
2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments
and Hedging Activities," and Amendment of FASB Statement No. 133. SFAS 161
amends SFAS 133, "Accounting for Derivative Instruments and Hedging Activities,"
to amend and expand the disclosure requirements of SFAS 133 to provide greater
transparency about (i) how and why an entity uses derivative instruments, (ii)
how derivative instruments and related hedge items are accounted for under SFAS
133 and its related interpretations, and (iii) how derivative instruments and
related hedged items affect an entity's financial position, results of
operations and cash flows. To meet those objectives, SFAS 161 requires
qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of gains and losses on
derivative instruments and disclosures about credit-risk-related contingent
features in derivative agreements. SFAS 161 is effective for fiscal years and
interim periods beginning after November 15, 2008. Earlier adoption is
encouraged. The Company is currently evaluating the impact of SFAS 161 on its
financial position, results of operations or cash flows.





In May
2008, the FASB issued SFAS No. 162, "The Hierarchy of Generally Accepted
Accounting Principles" ("SFAS 162"). SFAS 162 is intended to improve financial
reporting by identifying a consistent framework, or hierarchy, for selecting
accounting principles to be used in preparing financial statements that are
presented in conformity with U.S. GAAP for nongovernmental entities. SFAS 162 is
effective 60 days following the Securities and Exchange Commission's approval of
the Public Company Accounting Oversight Board auditing amendments to AU Section
411, "The Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles." The Company does not expect SFAS 162 to have a material
effect on its financial statements.





In May
2008, the FASB issued FSP APB 14-1, "Accounting for Convertible Debt Instruments
That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlements)." This FSP requires a portion of this type of convertible debt to
be recorded as equity and to record interest expense on the debt portion at a
rate that would have been charged on nonconvertible debt with the same terms.
This FSP takes effect in the first quarter of fiscal years beginning after
December 15, 2008 and will be applied retrospectively for all periods presented.
It will effective for the Company on July 1, 2009. This FSP would apply to the
Company's convertible debentures. The Company is currently evaluating how it may
affect the financial statements.  The Company does not currently have
any convertible debt instruments.





In June
2008, the FASB issued Staff Position ("FSP") EITF 03-6-1, "Determining Whether
Instruments Granted in Share-Based Payment Transactions Are Participating
Securities." Securities participating in dividends with common stock according
to a formula are participating securities. This FSP determined unvested shares
of restricted stock and stock units with nonforfeitable rights to dividends are
participating securities. Participating securities require the "two-class"
method to be used to calculate basic earnings per share. This method lowers
basic earnings per common share. This FSP takes effect in the first quarter of
fiscal years beginning after December 15, 2008 and will be applied
retrospectively for all periods presented. It will be effective for the Company
on July 1, 2009. The Company does not expect FSP EITF 03-6-1 to have a material
effect on its financial statements.





N. Reclassification– Certain
reclassifications have been made in prior year’s financial statements to conform
to classification used in the current year. Such reclassification of prepaid
expenses and other current assets has no effect on the balance of any one total
account.


F -
15
 Table of Contents


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 exclusive licenses in perpetuity for
technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian
(bird) flu, Influenza and rabies. The Company and TheraCour have agreed, in
principle, to an amendment to the existing Licensing Agreement to include
additional virus types among the virus types the Company is permitted to
manufacture, use, and offer for sale,, and for a payment of a license fee to
TheraCour. TheraCour has permitted the Company to use its nanomaterials to
develop a treatment for dengue fever until such time as the Company and
TheraCour can complete an amendment to the Licensing Agreement to include dengue
fever viruses, West Niles Virus, Japanese Encephalitis Virus, and others among
the virus types we are permitted to manufacture, use and offer for sale. 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 manufacture 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 (refundable) equal to twice the amount of the previous months invoice to
be applied as a prepayment towards expenses.





As to the
license fee, there can be no assurance that the license fee will be paid or that
the amendment will be become effective, in which case TheraCour may revoke our
permissive use of its materials, which may adversely impact our operations and
cause the termination of our Cooperative Research and Development Agreement
(CRADA) with the United States Army Medical Research Institute of Infectious
Diseases (USAMRIID), and The Walter Reed Army Institute of Research (WRAIR), and
the United States Armed Forces Institute of Pathology (USAFIP).





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. were $746,309 and $617,007
for the years ended June 30, 2008 and 2007, respectively and $2,086,979 since
inception. As of June 30, 2008, pursuant to its license agreement, the company
has paid a security advance of $236,186 to and held by TheraCour Pharma, Inc.
which is reflected in Prepaid Expenses. The development costs are partially
offset by a refundable Connecticut Research and Development tax credit of
$200,190.  No royalties are due TheraCour from the Company’s inception
through June 30, 2008





TheraCour
Pharma, Inc., is affiliated with the Company through the common control of it
and our Company by Anil Diwan, President, who is a director of each corporation,
and owns approximately 70% of the capital stock of TheraCour Pharma, Inc., which
itself owns approximately 30% 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, 2008.





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, 2008 and 2007 the Company evaluated its relationship with
TheraCour Pharma, Inc. for purposes of FIN-46R, and concluded that TheraCour
Pharma, Inc. is not a variable interest entity that is subject to consolidation
in the Company’s financial statements under FIN-46R.


F -
16
 Table of Contents


KARD
Scientific, Inc.





In June
2005, the Company engaged KARD Scientific to conduct pre clinical animal studies
and provide the Company with a full history of the study and final report with
the data collected from Good Laboratory Practices (CGLP) style
studies.  Dr. Krishna Menon, the Company’s Chief Regulatory Officer,
is also an officer and principal owner of KARD Scientific. Lab fees charged by
KARD Scientific for services for the years ended June 30, 2008 and 2007 were
$233,015 and $114,801 respectively and $554,235 since inception. In addition the
Company paid KARD a $50,000 advance payment towards future fees.








Note
5. Prepaids





Prepaids
at June 30 are summarized as follows:





2008
                                      
                                      
                                      2007TheraCour
      Pharma, Inc.
                                      
                                      $
                                      236,186
                                      
                                      
                                      $
                                      186,722Kard
      Scientific, Inc.
                                      
                                      
                                      50,000
                                      
                                      
                                      
                                      50,000Prepaid
      Others
                                      
                                      
                                      42,358
                                      
                                      
                                      
                                      15,000$
                                      328,544
                                      
                                      
                                      $
                                      251,722




(See Note
4. Significant Alliances and Related Parties)





Note
6 - Property and Equipment:





The costs
and accumulated depreciation of property and equipment are summarized as
follows:





June
      30,2008
                  
                  
                  2007Leasehold
      Improvements
                  
                  $
                  5,000
                  
                  
                  $
                  5,000Office
      Equipment
                  
                  
                  26,596
                  
                  
                  
                  14,334Furniture
      and Fixtures
                  
                  
                  1,400
                  
                  
                  
                  1,400Lab
      Equipment
                  
                  
                  108,911
                  
                  
                  
                  -Total
      Property and Equipment
                  
                  
                  141,907
                  
                  
                  
                  20,734Less
      Accumulated Depreciation
                  
                  
                  8,169
                  
                  
                  
                  2,247Property
      and Equipment, Net
                  
                  $
                  133,738
                  
                  
                  $
                  18,487





Depreciation
expense amounted to $5,922, and $2,247 for the years ended June 30, 2008, 2007
respectively.





Note
7. Deferred Financing Expenses





Deferred
Financing Expenses representing the value of cash payments and common stock
issued for attorney fees and to an investor as consideration for debt financing
during fiscal year ended June 30, 2006 were being amortized on a straight-line
basis over the term of the debenture.  Amortization expense for the
years ended 2008 and 2007 was $ -0- and  $ 6,714, respectively. The
debenture was converted to common stock  in May ,2007





Note
8 . 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 debenture holders in lieu of
interest on debentures as set forth in the contract. The Company recorded an
interest expense of $7,644 for the month of July 2006.


F -
17
 Table of Contents


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 $50,000 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 warrants to purchase
40,000 shares of common stock at $1.36 per share. These warrants, if not
exercised will expire in August 2010. The fair value of these warrants, by using
the Black-Scholes option pricing model, were valued at $30,184 and recorded as
consulting expense.





In
November 2006, the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock common stock at $1.19 per share. These
warrants, if not exercised will expire in November 2010.  The fair
value of these warrants, by using the Black-Scholes option pricing model, were
valued at $25,888, and recorded as consulting expense.





On
January 2, 2007, the Company entered into consulting agreements for future
services with Dr. Randall Barton for scientific consulting, and Mr. Harry
Schochat, Esq. for legal consulting.  The Company issued Dr. Randall
Barton 114,000 shares of its common stock and Mr. Harry Schochat, Esq. 102,000
shares of its common stock, for a total of 216,000 shares as upfront payments
(non-refundable) to these consultants. Based upon the fair market value of the
common stock on the commitment date, the Company recorded a consulting expense
of $164,160.





In
February 2007, the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock at $1.54 per share. These warrants, if
not exercised will expire in February 2011.The fair value of these warrants, by
using the Black-Scholes option pricing model,  were valued at $32,668
and recorded as consulting expense.





In May
2007, the Scientific Advisory Board (SAB) was granted warrants to purchase
40,000 shares of common stock at $1.30 per share. These warrants, if not
exercised will expire in May 2011.The fair value of these warrants, by using the
Black-Scholes option pricing model,  were valued at $25,664 and
recorded as consulting expense.





In June
2007, the Company's Board of Directors authorized the issuance of 752 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 $775.





In June
2007, 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 $115,000.





In June
2007, the Company's Board of Directors authorized the issuance of 15,791 shares
of its common stock with a restrictive legend to Dr. Randall Barton for
scientific consulting, 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 $16,800.





In June
2007, the Company's Board of Directors authorized the issuance of 14,099 shares
of its common stock with a restrictive legend to Mr. Harry Schochat, Esq. for
legal consulting, 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 $15,000.





In June
2007, 870,000 warrants  were converted into common stock, resulting in
the issuance of 1,305,000 common shares. The Company received $870,000 upon this
conversion in July, 2007. All holders of the Class A $2.50
warrants  and $1.00 warrants were provided an option to exercise their
warrants during a 30 day period at a price of $1.00 and to receive an additional
one half (1\2)share for each  Warrant converted.





In
August, 2007, the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock at $.80 per share. These warrants, if not
exercised, will expire in August, 2011.  The fair value of these
warrants in the amount of $14,800was recorded as a consulting
expense.


F -
18
 Table of Contents


In
August, 2008, the Company had received fully paid subscriptions in the aggregate
amount of $2,375,000 through the offering of shares of the Company’s common
stock (the “Offering”). The subscriptions are for shares of common stock at a
purchase price of $.50 per share and warrants to purchase 0.30 shares of common
stock at an exercise price of $1.00 per share; which warrants may be exercised
at any time and expire in three years. In accordance with the Offering, on
October 16, 2007, the Company issued 4,750,000 shares of common stock and
warrants to purchase 1,425,000 shares of common stock at an exercise price of
$1.00 per share. These warrants, if not exercised, will expire in fiscal year
ending in 2011. The Company allocated a relative fair value of $435,000 to these
warrants, by using the Black-Scholes option pricing model.  The
Company had agreed to use its best efforts to file a Registration Statement with
the Securities and Exchange Commission covering the resale of the Registrable
Securities issued or issuable pursuant to the Securities Purchase Agreement, and
to use its best efforts to obtain effectiveness of the Registration Statement on
or prior to one hundred and eighty days from the date of closing, and to keep
such registration statement continuously in effect. The company may be required
to issue additional warrants to purchase the company’s common stock if the
Registration Statement was not declared effective by the expiration of the
Effectiveness Period. On January 3, 2008 the Company filed a Form SB-2 with the
Securities and Exchange Commission. This filing became effective as of April 11,
2008





In
November, 2007 the Scientific Advisory Board (SAB) was granted warrants to
purchase 40,000 shares of common stock at $.54 per share. These warrants, if not
exercised, will expire in November, 2011. The fair value of these warrants in
the amount of $7,200 was recorded as a consulting expense.





In
February, 2008 the Scientific Advisory Board (SAB) was granted warrants to
purchase 50,000 shares of common stock at $.52 per share. These warrants, if not
exercised, will expire in February 2012. The fair value of these warrants in the
amount of $8,500 was recorded as a consulting expense.





In May,
2008 the Scientific Advisory Board (SAB) was granted warrants to purchase 50,000
shares of common stock at $1.48 per share. These warrants, if not exercised,
will expire in May, 2012. The fair value of these warrants in the amount of
$32,253 was recorded as a consulting expense





For the
year ended June  30, 2008, the Company's Board of Directors authorized
the issuance of 201,533 shares of its common stock with a restrictive legend,
for services. The Company recorded an expense of $111,921.





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 were vested
immediately and are exercisable from September  2005
until  September 2015, and the  remaining  options
vested annually on January 1, 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 were vested immediately and are exercisable from September 2005 until
September 2015, and the remaining options vested annually on January 1, in two
equal amounts.





In
September 2005, 500,000 stock options were granted to Leo Ehrlich, our former
CFO under an employment agreement. Of these options, 250,000 were vested
immediately and are exercisable from September 2005 until September 2015, and
the remaining options vest annually in two equal amounts.   On
May 16, 2007, Leo Ehrlich resigned as the Company's Chief Financial Officer. At
time of his resignation 375,000 options were vested and are exercisable from
September 2005 until September 2015.The remaining options were
forfeited.





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, $7,044 and
$27,062 was recognized as stock based compensation expense for the years ended
June 30, 2008 and 2007, respectively.





Note 9. 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 matured July 31,
2006 and carried an interest rate of 9% per year and were 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 was being amortized on a straight-line basis over
the term of these debentures. Amortization expense for the years ended June 30,
2008 and 2007 and since inception was $-0-, $82,918 and $713,079,
respectively.


F -
19
 Table of Contents


In July
2006, the debentures holders converted all outstanding debentures. As a result
of these conversions, the Company issued an aggregate total of 3,333,333 shares
of the Company's $.001 par value common stock.





For the
years ended June 30, 2008 and 2007 and since inception, interest expense on the
convertible notes in the amount of $ -0- and $7,644 and $73,930 respectively,
was paid by the issuance of -0-, 5,744 and 95,744 shares of the Company’s common
stock respectively.





Note
10. 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 June 30, 2006
                  
                  
                  2,000,000
                  
                  
                  
                  0.10
                  
                  
                  
                  9.25
                  
                  
                  
                  -Granted
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  -Exercised
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  -Expired
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  -Canceled
                  
                  
                  (125,000
                  )
                  
                  
                  .10
                  
                  
                  
                  -
                  
                  
                  
                  -Outstanding
      at June 30, 2007
                  
                  
                  1,875,000
                  
                  
                  $
                  0.10
                  
                  
                  
                  8.25
                  
                  
                  $
                  1,537,500Granted
                  
                  
                  -
                  
                  
                  
                  
                  
                  
                  
                  -
                  
                  
                  
                  -Exercised
                  
                  
                  -
                  
                  
                  
                  
                  
                  
                  
                  -
                  
                  
                  
                  -Expired
                  
                  
                  -
                  
                  
                  
                  
                  
                  
                  
                  -
                  
                  
                  
                  -Canceled
                  
                  
                  -
                  
                  
                  
                  
                  
                  
                  
                  -
                  
                  
                  
                  -Outstanding
      at June 30, 2008
                  
                  
                  1,875,000
                  
                  
                  
                  0.10
                  
                  
                  
                  7.25
                  
                  
                  $
                  2,437,500Exercisable at June 30,
2008
                  
                  
                  1,875,000
                  
                  
                  
                  0 .10
                  
                  
                  
                  7.25
                  
                  
                  $
                  2,437,500








As of
June 30, 2008 there was no unrecognized compensation cost.








Stock
Warrants




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
                                  
                                  
                                  
                                  1.65
                                  
                                  
                                  
                                  - -Granted
                                  
                                  
                                  160,000
                                  
                                  
                                  
                                  1.35
                                  
                                  
                                  
                                  2.50
                                  
                                  
                                  
                                  ---Exercised
                                  
                                  
                                  (1,070,000
                                  )
                                  
                                  
                                  1.21
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -Expired
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -Canceled
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -Outstanding
      at June 30, 2007
                                  
                                  
                                  2,695,000
                                  
                                  
                                  
                                  1.95
                                  
                                  
                                  
                                  .94
                                  
                                  
                                  
                                  ---Granted
                                  
                                  
                                  1,680,000
                                  
                                  
                                  
                                  1.00
                                  
                                  
                                  
                                  2.25
                                  
                                  
                                  
                                  -Exercised
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -Expired
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -Canceled
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -
                                  
                                  
                                  
                                  -Outstanding
      at June 30, 2008
                                  
                                  
                                  4,375,000
                                  
                                  
                                  $
                                  1.58
                                  
                                  
                                  
                                  1.46
                                  
                                  
                                  
                                  -Exercisable
      at June 30, 2008
                                  
                                  
                                  4,375,000
                                  
                                  
                                  $
                                  1.58
                                  
                                  
                                  
                                  1.46
                                  
                                  
                                  
                                  -


Of the
above warrants, 2,375,000 expire in fiscal year ending June 30, 2009; 160,000
expire in fiscal year ending June 30, 2010; 1,660,000 expire in fiscal year
ending June 30, 2011; and 180,000 expire in fiscal year ended June 30,
2012.


F -
20
 Table of Contents


The
Option Assumptions used to calculate these values are:





Expected
      life in years
                  4
      yearsRisk
      free interest rate
                  2.9%
      - 4.31%Expected
      volatility
                  74%
      - 133.03%Dividend
      yield
                  0%








Note
11. Income Taxes





Deferred
income taxes arise from the temporary differences between financial statements
and income tax recognition of net operating losses. The net operating loss
carryforwards will begin to expire in the year 2017 if not utilized. Utilization
of the Company's net operating loss carryforwards are limited based on changes
in ownership as defined in Internal Revenue Code Section 382. As of June 30,
2008 the Company accumulated a federal tax loss of approximately $6,702,000
resulting in a deferred tax benefit of approximately $2,901,000 which has been
offset by a 100% valuation allowance.





The
components of deferred tax assets as of June 30, 2008 and 2007 are as
follows:





June
      30 2008
                  
                  
                  June
      30 2007Net
      operating loss carryforwards
                  
                  $
                  2,901,100
                  
                  
                  $
                  1,611,400Research
      and development credit
                  
                  
                  773,100
                  
                  
                  
                  391,700Other
                  
                  
                  503,200
                  
                  
                  
                  526,300Gross
      deferred tax assets
                  
                  
                  4,177,400
                  
                  
                  
                  2,529,400Valuation
      allowances
                  
                  
                  (4,177,400
                  )
                  
                  
                  (2,529,400
                  )Deferred
      tax assets
                  
                  $
                  -
                  
                  
                  $
                  -





During
the year ended June 30, 2008, the valuation allowance increased by
$1,648,000.





During
the year  ended on June 30, 2008, the Company recognized a refundable
Research and Development tax credit of $200,190, and has received, to date,
$110,318 of this refundable credit . The remaining credit receivable is included
under “Other Current Assets” on the Company’s Balance Sheet.





The
Company adopted the provisions of Financial Accounting Standards Board (“FASB”)
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes (“FIN 48”),
on July 1, 2007. As required by Interpretation 48, which clarifies SFAS No. 109,
Accounting for Income Taxes, the Company recognizes the financial statement
benefit of a tax position only after determining that the relevant tax authority
would make more likely than not sustain the position following an audit. For tax
positions meeting this standard, the amount recognized in the financial
statements is the largest benefit that has a greater than 50 percent likelihood
of being realized upon ultimate settlement with the relevant tax authority. At
the adoption date, the Company applied Interpretation 48 to all tax positions
for which the statute of limitations remained open. The adoption of FIN 48 did
not have a material impact in the financial statements during the year
ended June 30, 2008.


F -
21
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Note
12. Commitments and Contingencies





OPERATING
LEASE





The
Company’s principal executive offices are located at 135 Wood Street, West
Haven, Connecticut, and include approximately 4,100 square feet of office and
laboratory space at a base monthly rent of $4,692. Commencing September 1, 2008
the Company rented additional storage space and the base monthly rent increased
to $4,892. The term of lease expires in February 28, 2011, and may be extended,
at the option of the Company, for an additional two years. The lease can be
cancelled by the Company upon providing six months written notice.





On
February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000
square feet of space at 4 Research Drive, in Woodbridge, Connecticut. The
term of the occupancy is until January 30, 2009 at a monthly rent of $11,667,
plus an additional $500 per month for utilities.





At June
30, 2008, future minimum rental payments due under these operating leases are as
follows:





Year
      EndingJune 302009
                                    
                                    
                                    143,2732010
                                    
                                    
                                    58,7042011
                                    
                                    
                                    39,136241,113





Total
rent expense amounts to $166,881 and $68,796 for the years ended June 30, 2008
and 2007 respectively, and $245,177 for the period from inception.








OFFICERS’
COMPENSATION





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 increased to $250,000 per year upon closing of a
financing to the Company as ofOctober 16, 2007. 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 exercisable into the Company’s common stock
at $0.10 per share:





£
            Dr.
      Anil Diwan received 1,000,000 options, 333,333 options vested upon
      execution of the employment agreement. Another 333,333 options vested on
      January 1, 2007. The remaining 333,334 options vested
      on  January 1, 2008 . The options expire September 26,
      2015.





£
            Dr.
      Eugene Seymour received 500,000 options, 250,000 options vested upon
      execution of the employment agreement. Another 125,000 options vested on
      January 1, 2007. The remaining 125,000 options vested
      on  January 1, 2008 The options expire September 26,
      2015.








The
employment agreements expired on September 26, 2008. The Company and two of the
executives have verbally  agreed to continue the executive
compensation under the same terms until a new agreement is put into
effect.





On May
16, 2007 Leo Ehrlich, formerly chief financial officer, resigned from the
Company. At the time of his resignation, and pursuant to an agreement between
Mr. Ehrlich and the Company, Mr. Ehrlich was owed $91,666 in earned, but
deferred compensation which was paid in the fiscal year ended June 30,
2008.


F -
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 Table of Contents


COOPERATIVE
RESEARCH AND DEVELOPMENT AGREEMENT (CRADA)





On April
4, 2007, the Company signed a Cooperative Research and Development Agreement
(CRADA) with the Walter Reed Army Institute of Research (WRAIR) to create new
treatments for Dengue Fever using the Company’s nanomedicine technology. The
Company is currently negotiating a modification to this agreement as requested
by WRAIR.





On
October 4, 2007, the Company signed a Cooperative Research and Development
Agreement for Material Transfer (CRADAMT) with the U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID) to create new treatments for
Filovirus using the Company’s nanomedicine technology. Each party is
individually responsible for funding its own respective researchers throughout
this agreement, including laboratory facilities, salaries, overhead and indirect
costs, etc.





On
February 4, 2008, the Company signed a Cooperative Research Agreement with the
United States Armed Forces Institute of Pathology (USAFIP) to test the efficacy
of the Company’s nanomedicine technology in preliminary animal studies against
H5N1 and HIV viruses. The company will fund such studies in the amount of
$122,844.





On
February 4, 2008, the Company signed a Technical Testing Agreement with a major
medical research institute. The agreement provides for certain animal studies to
test the efficacy of the Company’s nanomedicine technology against
Epidemic-Kerato Conjunctivitis (“EKC”) and other viral diseases of the cornea
and conjunctiva. The Company will fund the costs of these studies. These studies
commenced in May, 2008.





On July
3, 2008, the Company signed a Materials Cooperative Research and Development
Agreement (M-CRADA) with the Centers for Disease Control and Prevention (CDC)
for testing anti-rabies nanoviricides. The testing is expected to begin late in
the third quarter of 2008. The Company will fund $10,000 of this testing; all
other expenses are to be paid by the CDC.





While the
licensing agreement between the Company and TheraCour does not provide for the
use of the nanomaterials we license from TheraCour for the treatment of the
Filovirus, TheraCour has permitted the Company to use the nanomaterials to
develop a treatment for Filovirus until such time as the Company and TheraCour
can negotiate an amendment to the Licensing Agreement to include the Filovirus
among the virus types we are permitted to manufacture, use and offer for
sale.  While the Company is currently negotiating such an amendment
with TheraCour, there can be no assurance that an agreement will be reached, in
which case TheraCour may revoke our permissive use of its materials for
Filovirus and the EKC virus, which may adversely impact our operations and cause
the termination of our CRADA with the USAMRIID, WRAIR, USAFIP and the Technical
Testing Agreement with the Medical Research Institute.








OTHER
CONTINGENCIES





The
Company is dependent upon its license agreement with TheraCour Pharma, Inc. (See
Note 4).  If it  loses 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.





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.


F -
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 Table of Contents


Note
13. Subsequent Event





On August
22, 2008, the Company consummated subscriptions with certain investors whereby
the Company sold 3,286,000 shares (the “Shares”) of its common stock , par
value$0.001 per share (the “Common Stock”) and (“Warrants”) to purchase
1,643,000 shares of  Common Stock at an exercise price of $2.00 per
share for an aggregate purchase price of $3,286,000. The 3,286,000 share private
placement of stock included 150,000 shares of Common Stock and 75,000 warrants
subscribed in consideration of $150,000 of scientific testing and other
laboratory work performed for the Company. The Warrants may be exercised at any
time and expire on September 17, 2008.





Also on
August 22, 2008, the Company consummated subscriptions with certain of its
Warrant holders whereby the Company offered all the holders of its $2.50
Warrants the option of exercising the Warrants at $1.00 per share of Common
Stock, of which warrants to purchase 50,000 shares of Common Stock for an
aggregate price of $50,000 were exercised. Concurrently, the Company consummated
subscriptions with certain other of its Warrant holders whereby the Company
offered all the holders of its $1.00 Warrants the o ption of exercising the
Warrants at $0.75 per share of Common Stock, of which warrants to purchase
75,000 shares of Common Stock for an aggregate price of $56,250 were
exercised.







F - 24