Indicate by check mark whether the Company (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period
that the Company was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes
x
No
¨
Indicate by check mark whether the Company has submitted electronically
and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Company
was required to submit and post such files). Yes
x
No
¨
Indicate by check mark whether the Company is a larger accelerated
filer, an accelerated filer, or a non-accelerated filer. See definition of "accelerated filer and large accelerated filer"
in Rule 12b-2 of the Exchange Act. (Check one)
Indicate by check mark whether the Company is a shell company
(as defined in Rule 12b-2 of the Exchange Act).
The number of shares outstanding of the Company's Common Stock
as of February 14, 2014 was approximately: 53,957,000
PART I
The following discussion should be read
in conjunction with the information contained in the 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 the Company's Annual Report on Form 10-K for the year ended June 30, 2013. 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.
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 this 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.
Although these forward-looking statements
reflect the good faith judgment of our management, such statements can only be based upon facts and factors currently known to
us. Forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. As a result,
our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors,
including those set forth below under the caption “Risk Factors.” For these statements, we claim the protection of
the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not
unduly rely on these forward-looking statements, which speak only as of the date on which they were made. They give our expectations
regarding the future but are not guarantees. We undertake no obligation to update publicly or revise any forward-looking statements,
whether as a result of new information, future events or otherwise, unless required by law.
ITEM I: BUSINESS
Organization and Nature of Business
NanoViricides, Inc. is a leading company
in the application of nanomedicine technologies to the complex issues of viral diseases. The nanoviricide® technology enables
direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming
ineffective at infecting host cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points
per antibody.
The Company develops its drugs, that we
call nanoviricide® using a platform technology. This approach enables rapid development of new drugs against a number of different
viruses. A nanoviricide is a “biomimetic” - it is designed to “look like” the cell surface to the virus.
To accomplish this, we have developed a polymeric micelle structure composed of PEG and fatty acids, that is designed to create
a surface like the cell membrane, with the fatty acids going inside of the micelle. On this surface, we attach, at regular intervals,
virus-binding ligands. The virus is believed to be attracted to the nanomicelle by these ligands, and thereby binds to the nanoviricide
using the same glycoproteins that it uses for binding to a host cell. Upon such binding, a “lipid mixing” interaction
between the lipid envelope of the virus and the nanomicelle is thought to take place, leading to the virus attempting to enter
the nanomicelle. Many different kinds of viruses are likely to get destroyed in the process.
We engineer the ligands to “mimic”
the same site on the cell surface protein to which the virus binds. These sites do not change no matter how much a given virus
mutates. Thus we believe that if a virus so mutates that it is not attacked by our nanoviricide, then it also would not bind to
the human host cell receptor effectively and therefore would be substantially reduced in its pathogenicity. Our success at developing
broad-spectrum nanoviricides depends upon how successfully we can design decoys of the cell surface receptor as ligands, among
other factors.
The Company currently has six drugs in
development with very large commercial markets. These include (i) Injectable FluCide™ for hospitalized patients with severe
influenza, (ii) Oral FluCide™ for out-patients, (iii) DengueCide™, a broad spectrum nanoviricide designed to attack
all types of dengue viruses and expected to be effective in the Severe Dengue Disease syndromes including Dengue Hemorrhagic Fever
(DHS) and Dengue Shock Syndrome (DSS), (iv) HIVCide™ for HIV/AIDS, (v) HerpeCide™ for cold sores and genital sores
caused by HSV, and (vi) Broad-spectrum Anti-Viral Eye drops for adenoviral and herpesviral infections of the external eye. In addition,
the Company has research programs to develop drugs against Rabies virus, Ebola and Marburg viruses, as well as the recent MERS
Coronavirus (Middle-East Respiratory Syndrome). The Company also has a technology that we call “ADIF” or “Accurate-Drug-In-Field”
technology with which an effective drug can be developed against a novel virus right in the field using stockpiled nanoviricides®
precursors. The estimated market size for the current drug candidates is well in excess of $40 Billion worldwide.
We continue to achieve very strong performance
in the testing of these drug candidates. All of our biological testing is conducted by third parties.
Of these, our Injectable FluCide is the
most advanced. This drug candidate has shown extremely high effectiveness in a lethal influenza infection mouse model against two
different types of influenza A virus, namely H1N1 and H3N2. The Company believes that this drug should be effective against most
if not all influenza A subtypes, and strains, including the novel H7N9 strain. The Company held a pre-IND Meeting with the US FDA
for its clinical drug candidate NV-INF-1 (i.e. Injectable FluCide) in the FluCide program in March 2012. The Company obtained valuable
advice and is developing this candidate towards an investigational drug application (“IND”) to the US FDA as well as
for similar applications to other international regulatory agencies. The Company recently performed a short preliminary non-GLP
study designed to guide the planned GLP Safety and Toxicology studies (“Tox Package”) that are required for an IND
filing. On October 7, 2013, the Company announced that in this small animal non-GLP safety/toxicology study of NV-INF-1 drug candidate,
even at maximum feasible dosage, the drug was well tolerated and that no adverse events were found at study completion. . On December
2, 2013, the Company reported that detailed laboratory analyses of samples from this non-GLP safety and toxicology study showed
no overall systemic effects and no direct effects on the primary organs. This includes liver and kidney tissues as well as liver
and kidney function. This is important as the liver and kidneys are major organs involved in drug toxicity. In addition, FluCide
showed no adverse effects on the lungs from the treated animals. This is very important because the respiratory system is a primary
site of influenza virus infection and tissue damage. These strong safety findings were seen at all doses tested, even at the maximum
feasible dose (MFD). MFD was much higher than the therapeutic dose range used to treat influenza virus infections in our animal
model efficacy studies. FluCide was administered intravenously by tail-vein injections or by infusion in this study. The non-GLP
safety/toxicology study was conducted at KARD Scientific in Massachusetts.
These results support the Company’s
positive findings in animals that were infected with different influenza A virus strains. In those studies, no safety or toxicology
concerns were observed. The Company has previously reported that its FluCide candidate demonstrated extremely high anti-influenza
activity in lethal infection animal models using multiple influenza A subtypes. The extremely high anti-influenza activity
coupled with the strong safety data were the basis for the selection of this FluCide candidate for further drug development. As
previously reported, the results of this study will provide both the basis and focus for the GLP safety and toxicology studies
of FluCide that are required for the IND submission to the U.S. FDA. These GLP studies will be performed on both large and small
animals at the BASi facility in Indiana.
The Company believes that these strong
safety data bode well for our other drug programs as well. This is because a nanoviricide is built of two parts – (1) a virus
specific ligand, that is chemically attached to (2) a “nanomicelle” or polymeric micelle based on our specific chemistries.
It is reasonable to believe that the nanomicelle structures of our other drug candidates should also be safe. In addition, we believe
that we have chosen antiviral ligands for our other drug candidates in a very conservative, safety-biased fashion.
The Company is currently performing process
development and scale up studies on its FluCide drug candidate in its existing facilities. Upon scale-up, we will be able to produce
the quantities of materials we need for the GLP Safety/Toxicology study of the injectable FluCide drug. We intend to begin the
GLP Safety/Toxicology study as soon as feasible.
The Company has previously announced that
its anti-dengue drug candidate in the DengueCide™ program achieved an unprecedented 50% survival rate in a special mouse
model that mimics the most severe dengue disease in humans. This study was performed by Professor Eva Harris at the University
of California, Berkeley.
On August 12, 2013, the Company announced
that this anti-dengue drug candidate has been awarded an orphan drug designation by the US FDA. On November 11, 2013, we announced
that this anti-dengue drug candidate was also awarded an orphan drug designation by the European Medicines Agency (EMA). These
orphan drug designations provide the Company with several financial and other benefits that have now enabled the Company to give
a high priority to the development of this drug.
In addition, the Company is developing
a flexible, multi-product, pilot manufacturing facility capable of manufacturing any of its drug candidates in c-GMP compliant
manner. This facility will be able to provide the cGMP clinical drug substances for its future human clinical studies. (“c-GMP”=
current Good Manufacturing Practices, a set of guidelines developed by the US FDA that the manufacture of a drug must adhere to
for human clinical trials and future sales. Internationally, there are similar guidelines promoted by local regulatory agencies,
and ICH harmonization guidelines promoted by the WHO). A group of private financiers that includes our founder Dr. Anil Diwan has
acquired an 18,000 sqft building on 4 acres with possibilities of expansion, in Shelton, CT, via Inno-Haven, LLC, a company formed
specifically for that purpose. This building is now undergoing a total renovation to facilitate setting up a modern cGMP drug substance
manufacturing facility with injectable drugs capability, as well as supporting analytical and chemistry laboratory facilities.
We have assembled a marquee team of experts
to help with the design, engineering, architecture, and construction of this facility. Mr. Andrew Hahn continues to provide overall
stewardship for this project. He was formerly Senior Director of Engineering, Pharmaceutical Facilities, Global Engineering, at
the Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He has almost 30 years of experience in architecture, design
and project management in the creation of new and refurbished facilities at Bristol-Myers Squibb Company. Mr. Phil Mader and his
firm, MPH Engineering, LLC (“MPH”), continue to help with the overall project management and design engineering of
the laboratory and cGMP pilot production facility. Prior to founding MPH, from 2000 to 2007, Phil Mader served as the Senior Capital
Project Manager at Bristol-Myers Squibb Company in Wallingford, CT (“BMS”). He was involved in the design, implementation,
and commissioning of various biology and chemistry laboratory projects within budget and in a timely manner. Ms. Kathyann Cowles
of ID3A, LLC, serves as the Principal Architect. Ms. Cowles, co-founder of Id3A, has over thirty years of experience
as a licensed Architect and Senior Project Manager for diverse and complex design and construction projects in the
academic, science, technology, corporate and research sectors. This team is working with the expert advice and guidance
of the Company’s Scientific Advisor, Dr. Harmon Aronson. Dr. Aronson is a well-known cGMP consultant in the pharmaceutical
industry, and was formerly Vice President of Quality Management at Biocraft Laboratories, a company that was acquired by Teva Pharmaceuticals.
This renovation project is now in the construction
phase. The construction is projected to be substantially complete in the first calendar quarter of 2014. We intend to lease the
building from Inno-Haven, LLC. The terms of the lease have not been finalized.
After the construction is completed, we
will need to set up new equipment and ensure that its performance is adequate. Thereafter we will need conduct several validation
studies and also move our current laboratories to the new facility. In addition, we will need to set up cGMP compliant systems
for working in this new facility. We will need to establish the scaled up manufacturing processes of our drug candidates under
cGMP guidelines in this facility. Only after that, the Company will be able to make cGMP-like material using the same processes
as c-GMP material but prior to undergoing the FDA registration process. Such c-GMP-like product can be used for clinical batches
for human clinical studies in several countries around the world. The Company is currently investigating all such options in order
to expedite the timeline to entering human clinical trials. The Company intends to contract out clinical batch fulfillments to
outside established contract manufacturers.
In August 2012, we announced that we were
successful in developing an anti-influenza drug candidate that was orally effective. We believe this may be the very first targeted
nanomedicine that is available via the oral route. Oral availability of FluCide would open up a much larger market than the injectable
version. The Company intends to continue to develop the injectable version for hospitalized patients. For severe, hospitalized
cases of influenza, we are developing a concentrated solution that is administered by “piggy-back” incorporation into
the standard IV fluid supplement system that is commonly used in hospitalized patients. In addition, we now plan to develop an
oral version for out-patients and later also for pediatric patient populations. This oral version will replace the injectable drug
that we were developing for out-patients.
In September 2012, we announced that the
oral version of FluCide was also highly effective against a different strain of influenza A, namely H3N2, in addition to the influenza
strain of H1N1 that we had been using for development, in the same lethal animal challenge model. This is an important indication
that our drug candidates against influenza are indeed broad-spectrum, i.e. capable of combating most if not all influenza viruses.
We will need to perform animal studies against a few additional strains of influenza viruses in order to substantiate that this
drug is indeed a broad-spectrum drug candidate. Additional studies in cell cultures against different strains of influenza are
also planned. All of these studies are necessary for filing an IND application.
Nanoviricide technology is built on the
TheraCour® polymeric micelle platform technology. The design of these materials is like building blocks. We can select components
to achieve desired effects. This tailor-made customizability has many implications. It allows us to (1) rapidly create a new drug
against a different virus; (2) rapidly develop a drug with desired length of time for which its effect should persist; and (3)
quickly develop new drugs with different routes of administration; among many other benefits.
We had always suspected that the polymeric
nature of nanoviricides would enable a long drug effectiveness time frame, thus enabling infrequent dosing. We have indications
now that this is very likely true, from both FluCide™ and HIVCide™ programs. We have observed sustained antiviral effects
for a long time after last drug administration in various animal model studies.
Infrequent dosing would translate into ease of patient compliance.
Patient compliance is a major issue for all antiviral drug therapies, and particularly for HIV/AIDS.
We have been able to develop drugs using
many different routes of administration with very little development time and effort.
Initially we focused on developing only
injectable formulations since these afford the maximum bioavailability of the drug inside the body. We have also developed eye
drop solutions against EKC in a very short time frame.
A skin cream appears to be the right formulation
for the treatment of oral and genital warts caused by HSV-1 and HSV-2. Last year we had already observed that our drug candidates,
in the solution form, were effective in cell cultures against at least two different strains of HSV-1 in two different laboratories.
We needed to make skin creams for conducting animal studies and selected different building blocks for our backbone polymer, and
built new drugs against HSV this year. The skin cream drug candidates against HSV were developed within a matter of weeks. The
formulation development itself took only a few days. In contrast, many drug development companies spend years in formulations development.
We have successfully developed what may
be the first ever orally available targeted nanomedicine, in our Flucide program.
We demonstrated that we can rapidly develop
different formulations because of the inherent strength of the nanoviricide platform technology. The technology also enables us
to develop nasal sprays and bronchial aerosols. We plan to develop the appropriate formulations as necessary.
We have limited our expenditures on socially
conscious projects such as “Neglected Tropical Diseases” (NTD’s), and “Bio-defense” projects to the
extent that participatory funding from third parties is available. To this end, we attempt to obtain grants and contracts financing
from government and non-government sources. We will continue to work on these programs as time and resources permit. In addition,
we continue to develop novel technologies such as ADIF™ (“Accurate-Drug-In-Field™”) which may possibly
represent one of the best scientific approaches against manmade and natural novel disease agents. Outbreaks of natural novel viral
diseases, such as MERS-CoV, SARS-CoV, H7N9 Influenza, and others, will continue to occur. At present, there is no feasible therapeutic
intervention for outbreaks of novel viruses, such as new MERS coronavirus outbreak reported recently.
We have added two marquee independent board
members to our Board of Directors in May/June, 2013. Dr. Milton Boniuk is the Caroline F. Elles Chair Professor of Ophthalmology,
in the Alkek Eye Center at the Baylor College of Medicine, Houston, TX, a practicing ophthalmic surgeon, an astute businessperson,
a renowned humanitarian, and a strong investor in and supporter of the Company. To date, he has invested $7M into NanoViricides,
Inc., through various entities. Dr. Mukund S. Kulkarni, MBA, PhD, is currently the Chancellor of Penn State University, and continues
to be Professor of Finance. Together with Mr. Stanley Glick, Practicing CPA and Chair of our Audit Committee, we now have a majority
of independent board members.
We have continued to successfully raise
financing. We had previously completed a $6M convertible debentures placement with our prior investors with long positions in February,
2013. In addition, we completed a registered direct offering of approximately $10M on September 9, 2013, after reverse-split of
our common stock by a factor of 3.5 old common shares for 1 new common share. With the newly established stock price, subsequently,
we met the eligibility criteria for both NASDAQ and NYSE MKT.
On September, 25, 2013, the Company’s
common stock began trading on the NYSE MKT exchange under the symbol NNVC. This up-listing from OTC bulletin board was the culmination
of a year long effort spearheaded by Dr. Anil R. Diwan, our founder. The Company had announced at its annual meeting on January
16, 2013, that it had undertaken an initiative to improve its corporate governance, build a stronger and independent board of directors,
and prepare the Company for uplisting to a major national exchange. The Company studied and evaluated the processes and performance
at the major national exchanges and determined that it was in the best interests of our shareholders to uplist to NYSE MKT. Midtown
Capital Partners, LLC, and Chardan Capital Markets, LLC advised the Company throughout this process and also served as the joint
placement agents for the $10M registered direct offering referenced above.
This uplisting is a major milestone for
the Company and an important advance in the Company’s corporate lifecycle.
The annual meeting of the Company’s
shareholders was held on December 9th in Stamford, CT. The meeting was well attended in spite of poor weather conditions. All
of the Directors of the Company were present. Professor MukundKulkarni and Mr. Stanley Glick were present in person. Dr. Milton
Boniuk had sent Ms. Debra Boniuk, his daughter and legal counsel to his charitable foundation, as his representative. In addition,
two of the Company’s Scientific Advisory Board members, namely Dr. Harmon Aronson, and Professor Thomas Lentz, also attended
the meeting. The Company has unveiled its completely redesigned website in time for the annual meeting. The new website provides
access to the CEO’s presentation, our press releases, our technologies, as well as our SEC filings and other documents.
This website is built with modern technologies including CSS and HTML5 to allow flexible design and simplifying future updates.
As of December 31, 2013, the Company has
current assets of approximately $17MM and additional cash provided as security deposits for the new facility of $2M, for a total
of $19MM available cash.. The Company continues to be frugal in its expenditures, and has successfully held the rate of operational
cash expenditures at approximately $1.75M this quarter. We believe we have sufficient funds in hand for more than two years of
operations at the current rate of expenditure.
Subsequent to the reporting period, we
have raised approximately $20MM (or approximately $18.8MM net of commissions) on January 21, 2014. With this additional cash,we
believe we have sufficient funds in hand to complete Phase I and Phase IIa human clinical studies for at least one of our drug
candidates, and advance, at least, one more drug candidate into human clinical studies. Our estimate is based on a number of assumptions
and cost estimates provided by outside parties. The Company itself does not have the expertise in taking a drug through human clinical
trials and as such depends upon outside experts to generate such estimates as well as to help the Company formulate and conduct
its drug development programs. As such, these estimates may be grossly in error and there may also be hidden costs that we are
not aware of.
Our strategy is to minimize capital expenditure.
We therefore rely on third party collaborations for the testing of our drug candidates. We continue to engage with our previous
collaborators.
In November 2013, we renewed our contract
with the Professor Eva Harris lab at the University of California at Berkeley for evaluation and development of our Denguecide
drug candidate. With cases in Florida, Texas and recently in New York, in addition to 25,000 suspected cases reported in Puerto
Rico this past summer, dengue virus is clearly becoming an important pathogen of concern in the United States.
We have engaged Biologics Consulting Group,
Inc., to help us with the US FDA regulatory submissions. We are also engaged with Australian Biologics Pty, Ltd to help us with
clinical trials and regulatory approvals in Australia. We believe that cGMP-like manufactured product is acceptable for entering
human clinical trials in Australia.
In addition, we have recently signed “confidential
disclosure agreements” (CDAs) with (1) Lovelace Respiratory Research Institute (LRRI), New Mexico, USA, (2) Public Health
England (PHE), UK, and most recently (3) Viroclinics Biosciences, BV, the Netherlands. We anticipate completing master services
agreements with these parties and, thereafter, initiate antiviral testing programs. In particular, we anticipate the IND-enabling
studies involving testing of FluCide against several influenza strains to be conducted at these facilities. In addition, PHE-UK
and Viroclinics have both been at the frontiers of the study of novel virus infection breakouts, such as MERS (Middle East Respiratory
Virus), and previously, SARS.
We have continued to achieve significant
milestones in our drug development activities. All of our drug development programs are presently at pre-clinical stage. We continue
to test several drug candidates under each program even though we may achieve extremely strong results with some of the candidates.
The Company reports summaries of its studies
as the data becomes available to the Company, after analyzing and verifying the same, in its press releases.
In July-August 2011, we reported on the
anti-HIV studies that were designed to discriminate the comparative effectiveness of different ligands. We reported that our lead
anti-HIV candidate achieved anti-HIV efficacy equivalent to a HAART (highly active anti-retroviral therapy) triple drug cocktail
in this recently completed animal study. Treatment with this lead anti-HIV nanoviricide reduced HIV levels and protected the human
T cells (CD4+/CD8+) to the same extent as treatment with the HAART cocktail. The three drug HAART cocktail used for comparison
in this study is one of the combination therapies recommended for initial therapy in humans. No evidence of drug toxicity was observed
in the case of nanoviricide drug candidates. We later reported that this lead anti-HIV drug candidate achieved a long term anti-HIV
effect with a much shorter dosing regimen and a markedly lower total drug dose than the HAART drug cocktail therapy in a recent
animal study. The antiviral effect of the anti-HIV nanoviricide (“HIVCide™”) continued throughout the 48 days
of study even though HIVCide dosing was discontinued after only 20 days. The clinical benefit of HIVCide was found to be sustained
for at least four weeks after the last drug dose. Treatment with the lead anti-HIV nanoviricide both (1) reduced the HIV viral
load and (2) also protected the human T cells (CD4+,CD8+), equally well as compared to treatment with the three-drug HAART cocktail,
at 24-days as well as at 48-days, even though the HIVCide treatment was stopped at 20 days. The lead candidate is now undergoing
further optimization.
In September 2013, we announced that we
had further improved the HIVCide drug candidates, based on results of cell culture studies conducted by Southern Research Institute,
Frederick, MD. A broad-spectrum anti-HIV-I activity was demonstrated in that HIV-1 Ba-L, a CCR5-using strain as well as HIV-1 IIIB,
a CXCR4-using strain, were both inhibited equally well by two different nanoviricide drug candidates in the standard MAGI HIV Antiviral
Assay
A long and sustained effect of HIVCide
would lead to improved patient compliance, which is a sought after goal in HIV therapy. With this new study, we believe that we
are close to a “Functional Cure” of HIV wherein the patient can take treatment until the viral load is undetectable
and then stop treatment until an episode of virus reawakening occurs. Anti-HIV drug development is very expensive and therefore
the Company continues to keep this program at a lower priority than our other drug development programs.
In September 2011, we announced that we
have selected a clinical candidate, now designated NV-INF-1, for FDA submission in our highly successful FluCide™ anti-influenza
therapeutics program. The Company is now developing certain additional information on NV-INF-1, with input from its FDA consultants,
for the pre-IND application to the FDA. The Company is planning on two separate indications for NV-INF-1: High strength dosage
form for hospitalized patients with severe influenza, and a single course therapy for the out-patients with less severe influenza.
We are currently working on putting together the FluCide information in a pre-IND application to the US FDA.
In July 2011, we retained the Biologics
Consulting Group to help us with our regulatory filings. This led to our pre-IND meeting request to the US FDA in December, 2011,
and a pre-IND meeting with the US FDA in March, 2012.
In July 2012, we retained Australian Biologics
Pty. Ltd., a regulatory affairs consulting firm, to coordinate the regulatory review and approval to conduct the first human trials
in Australia for Flucide™, the Company’s broad-spectrum anti-influenza drug. Australian Biologics will also facilitate
clinical trial site(s) selection and development of the clinical trials agreements. Dr. Jim Ackland, the Manager of Australian
Biologics Pty, Ltd, has extensive experience in this field. Prior to becoming managing director of this company, he was Vice-President,
West Coast and Asia Pacific operations for the Biologics Consulting Group, the Company’s US FDA regulatory affairs consulting
group. In the 1990’s, he was the Head of Regulatory Affairs, Vaccines, for the CSL Group in Australia. The CSL Group is a
global, specialty biopharmaceutical company that researches, develops, manufactures and markets products to treat and prevent serious
human medical conditions.
In August 2012, we reported that oral effectiveness
of anti-influenza FluCide drug was demonstrated in a lethal animal model. Certain anti-influenza drug candidates under our FluCide™
program, when given orally, were nearly as effective as when administered as IV injections. Two different anti-influenza drug candidates
were tested in Oral vs. IV comparison, and both of them showed similar results that indicated strong oral effectiveness. The results
clearly demonstrated that oral administration of both of these FluCide drug candidates resulted in substantially superior animal
protection compared to oseltamivir (Tamiflu®), a standard of care for influenza at present. The studies involved the same highly
lethal animal model the Company has continued to use for its influenza drug development program.
One of the FluCide drug candidates, when
administered orally, enabled the animals to survive as long as 347.4±4.6 hrs. (14.5 days), and when given as an injectable,
it allowed the animals to combat the lethal influenza infection for 376.8±7.5 hrs. (15.7 days). Another drug candidate (with
a different anti-viral ligand), when given orally, resulted in the animals surviving for as long as 301.3±5.2 hrs. (12.6
days), and when given as a tail-vein injection, for 349.0±3.9 hrs. (14.5 days). For comparison, untreated control animals
died in 119.5±1 hrs. (5 days), and oseltamivir (Tamiflu®) treated animals died within just 181.7±4.6 hrs. (7.6
days).
The survival data clearly showed that oral
as well as IV administration of FluCide drug candidates was substantially superior to oseltamivir. In addition, they showed that
FluCide drug candidates when given orally had substantial efficacy, almost matching the effectiveness of the injectable form given
at 0.3X of the oral dosage level.
One of the FluCide drug candidates, when
administered orally, resulted in 1.30 log reduction (or 20X reduction) in lung viral load and matched the viral load reduction
on the same drug candidate given as an IV injection. Another drug candidate resulted in 1.23 log viral load reduction when given
orally and 1.31 log viral load reduction when given as an injectable. In contrast, oseltamivir (Tamiflu®, given orally at 40mg/kg/d)
resulted in only 0.6 log viral load reduction (or only 4X reduction) compared to negative controls. These were the results of lung
viral load measured at 108 hours post-infection (hpi). Further, at 180 hpi, the lung viral load remained controlled at about the
same level as at 108 hpi with the nanoviricide® drug candidates. In contrast, lung viral load in the oseltamivir treated mice
increased to the same level as the negative control (infected untreated) animals prior to their death and the oseltamivir group
exhibited a survival of only 182±4 hours.
The number of lung plaques and plaque areas
(resulting from the influenza virus infection) also were consistent with the data from the lung viral load, and were minimal in
the case of the nanoviricide drug candidates whether given as IV or orally. Oseltamivir treatment did not protect the lungs of
infected animals anywhere close to the protection afforded by the FluCide drug candidates.
These data clearly demonstrated that both
oral and IV treatment with nanoviricide drug candidates protected the lungs of the mice infected with influenza virus equally well.
It is also clear that this lung protection was the result of the substantial decrease in the lung viral load. In addition, they
show that FluCide drug candidates when given orally had substantial efficacy, almost matching the effectiveness of the injectable
form given at 0.3X of the oral dosage level.
In addition to the antiviral effects, the
oral FluCide drug candidates also led to generation of a strong antiviral antibody response. Two different anti-influenza drug
candidates were tested in Oral vs. IV comparison. One of the FluCide drug candidates, when administered orally, resulted in 1866±90
micro-g/ml-plasma of anti-influenza antibody, and 1258±59 when administered as IV injections. Another FluCide candidate,
when given orally, resulted in 1491±37 ug/ml plasma of anti-influenza antibody, and 1151±53 when administered as
IV injections. The untreated infected animals had 190±22 ug/ml antibody response, which was the weakest of all, as expected.
Of significance, oseltamivir (Tamiflu) resulted in only 950±64 ug/ml level of antibody response, which was far less than
the two oral FluCide groups (p-value <0.0003), and also substantially less than the two IV FluCide groups (p-value <0.04).
These p-values were determined for a comparison of FluCide groups against the oseltamivir group using the most stringent parameters,
viz. two-tailed, paired, t-test. A smaller p-value indicates a greater confidence that the difference in observations cannot be
a result of pure chance. These data also indicated that the antibody response was stronger when FluCide was given orally rather
than as IV injection.
The generation of a strong antibody response
is important. We believe that the strong reduction in viral load caused by FluCide treatment allows the immune system to function
normally and generate appropriate antibodies. A strong antibody response implies that the FluCide drug candidates may also be useful
as prophylactic therapy of uninfected health care workers and close associates of a patient in addition to treatment of infected
patients.
All of these data also clearly demonstrated
that both injectable and oral FluCide™ candidates were superior to oral oseltamivir (Tamiflu®, Roche), a current standard
of care for influenza, in all parameters evaluated.
No adverse effects were found, indicating
that the FluCide dose could be increased further to achieve much greater levels of effectiveness.
The oral FluCide candidate development
was the result of chemistry optimization program that the Company has been working on.
In September 2012, we announced that the
oral FluCide™ drug candidates demonstrated dramatically improved survival in animals administered a lethal dose of the H3N2
influenza A virus. Animals treated with the oral anti-influenza nanoviricide drug candidates survived for much longer as compared
to Tamiflu® treated animals.
In this H3N2 infection study, animals treated
with the best of the oral FluCide™ nanoviricide drug candidates survived 15.6 days while the animals treated with oral Tamiflu
survived only 9.6 days. The control animals died within 5 days. The Company has previously reported that animals treated with these
same oral anti-influenza nanoviricides protected mice infected with the H1N1 influenza A virus and were similarly substantially
superior to oral oseltamivir (Tamiflu).
This is the first demonstration of efficacy
of the Company’s FluCide drug candidates against a completely unrelated type of influenza A virus (viz. H3N2) in contrast
to the H1N1 Influenza A virus that the Company has used for its recent development work leading to its pre-IND application with
the US FDA. H3N2 influenza virus is one of the multiple sub-types of influenza A that cause seasonal epidemics. According to the
CDC, influenza causes approximately 36,000 deaths every year in the U.S. alone. The Hong Kong Flu pandemic of 1968-1969, which
killed an estimated one million people worldwide, was caused by a variant strain of H3N2. The Company believes an orally administered
nanoviricide that protect against multiple influenza virus sub-types would be effective in season after season of influenza epidemics.
Such a highly effective, broad-spectrum anti-influenza drug is widely anticipated to be highly successful.
The Company believes that the anti-influenza
drug candidates it has developed are broad-spectrum, i.e. they should work against most if not all of influenza viruses. This is
because, in spite of mutations and antigenic drift, all influenza viruses bind to the same cell surface receptor called sialic
acid, and the Company has developed small chemical ligands that mimic this receptor, to attack the influenza viruses. These ligands
are chemically attached to the Company’s polymeric micelle backbones that mimic the cell membrane, to create the nanoviricides.
The Company has previously shown effectiveness of its very early anti-influenza drug candidates against two different strains of
H5N1 Bird Flu virus in cell culture studies. The Company has since then improved the ligands as well as the chemistries as reported
from time to time.
The Company intends to develop data about
effectiveness of its drug candidates against certain unrelated influenza A viruses using both cell culture studies and animal models
in a reasonable manner. These data will be needed as part of the IND application that the Company is working on. An IND application
will be required for the Company to enter into human clinical trials.
Previously, in June 2010, the Company reported
successful studies in two different cell culture models of dengue virus type 2 infection. These studies were conducted at the Prof.
Eva Harris lab at the UC Berkeley. Our results were later confirmed and extended to animal studies.
The Company reported that its anti-Dengue
drug candidates demonstrated significant protection in the initial animal survival studies of Dengue virus infection, in an animal
study protocol modeled to simulate the ADE syndrome. The best nanoviricide drug candidates demonstrated 50% animal survival in
this uniformly lethal mouse model. The studies were performed in the laboratory of Dr. Eva Harris, Professor of Infectious Diseases
at the University of California, Berkeley (UC Berkeley).
Based on this data, the Company believes
that it is feasible to develop a single nanoviricide drug against all types of dengue viruses that circumvents the primary issue
of antibody-dependent enhancement (ADE) of dengue virus infection. ADE is thought to result in severe dengue disease syndromes
such as dengue shock syndrome (DSS) and dengue hemorrhagic fever (DHF).
In June, 2010, we also reported that our
anti-HIV drug candidates demonstrated efficacy in the recently completed cell culture studies using two distinctly different HIV-1
isolates. These studies were performed in the laboratory of Carol Lackman-Smith at the Southern Research Institute, Frederick,
Maryland. These results corroborated our previous findings in Animal Studies. The Company had reported that its best nanoviricide
drug candidate against HIV was more than 25 times superior to a three drug combo anti-HIV cocktail based on biomarker test response
in all parameters tested. The parameters included improvement in human T cell populations in the animal model and reduction in
HIV viral load. The Company has since performed additional studies to optimize the HIV binding ligand and has found ligands that
are superior to the one that yielded these strong results. The Company now plans to deploy this new anti-HIV ligand connected to
the full strength polymeric micelle that we have also optimized as a new anti-HIV nanoviricide drug candidate. We plan to test
this optimized anti-HIV drug candidate in animal studies. Anti-HIV studies are extremely expensive. As such, the Company’s
HIVCide program has been slowed down with the current slow financial markets.
In August 2010, we reported that our anti-HSV
drug candidates exhibited almost complete inhibition of herpes simplex virus HSV-1 in cell culture studies conducted in Professor
Ken Rosenthal lab at the Northeastern Ohio Universities Colleges of Medicine and Pharmacy. These studies employed the H129 strain
of herpes simplex virus type 1 (HSV-1). H129 is an encephalitic strain that closely resembles a clinical isolate; it is known to
be more virulent than classic HSV-1 laboratory strains.
In March through May 2011, the Company
reported that further chemistry optimization led to dramatically improved antiviral efficacy with its optimized FluCide™
drug candidates in its most recent animal study. In the influenza mouse lethal infection model, animals treated with one of the
optimized FluCide™ nanoviricide drug candidates survived beyond the stated full duration of study (21 days), and those treated
with two additional drug candidates survived almost the full duration of the study. Animals in these three groups survived significantly
longer (20.2 to 22.2 days) as compared to the animals treated with Oseltamivir (Tamiflu®) only 8.3 days. In addition, the post-infection
treatment with these optimized FluCide™ drug candidates resulted in dramatic reduction in the number of lung lesions that
are caused by a lethal influenza virus infection. Four days post virus infection, animals treated with three of the optimized FluCide™
nanoviricide drug candidates exhibited greater than 95% reduction in the number of lung lesions as compared to the infected yet
untreated control animals (p-values < 0.001). In contrast, animals treated with Oseltamivir (Tamiflu®, Roche) showed only
a 50% reduction. In another significant finding, no increase in the number or size of the lung lesions was observed over the entire
duration of the study in the FluCide™-treated animals. This was not the case for the Oseltamivir-treated animals. This demonstrated
that treatment with FluCide drug candidates provided clear and strong protection against lung damage caused by the severe influenza
infection. In addition, in this study, these optimized FluCide™ drug candidates achieved 1,000-fold reduction in the levels
of infectious virus in the lungs of animals with a lethal level of influenza virus infection. The amount of infectious virus in
the lungs of the infected animals treated with three of the optimized FluCide™ nanoviricide drug candidates was reduced by
greater than 1000-fold as compared to the infected untreated control animals (p-values < 0.001), four days after virus infection.
In contrast, animals treated with Oseltamivir (Tamiflu®, Roche) showed less than a 2-fold reduction in lung viral load at the
same time point. This indicated a 500-fold greater reduction in viral load by FluCide drug candidates over Oseltamivir. Of great
clinical significance is the fact that 2 of the optimized FluCide™ drug candidates maintained this greatly reduced lung viral
load at 7, 13 and 19 days after virus infection in this 21 day study. Thus, treatment with the optimized FluCide drug candidates
appeared to protect against the complete cycle of infection, virus expansion and spread of infection in the lungs that follows
the initial virus infection. This was not the case for the Oseltamivir-treated animals. Animals treated with Oseltamivir (Tamiflu®,
Roche) showed less than a 2-fold reduction in lung viral load at 4 days and the viral load was increased at 7 days to the same
level as that found in the infected, untreated control animals shortly before their death.
In September 2011, we announced that we
have selected a clinical candidate, designated NV-INF-1, for FDA submission in our highly successful FluCide™ anti-influenza
therapeutics program. The Company submitted a pre-IND application to the FDA for this clinical candidate and held a pre-IND meeting
with the US FDA in March, 2012. In addition, the Company is planning a high strength “piggy-back infusion” dosage form
for hospitalized patients with severe influenza. The Company will continue the development of these two drug candidates towards
an IND, based on the guidance it received in the first pre- IND meeting.
The studies of biological testing of materials
provide information that is relatively easy to understand and therefore readily reported. In addition, we continue to engage in
substantial work that is needed for the optimization of synthesis routes and for the chemical characterization of the nanoviricide
drug candidates. We also continue to work on improving the drug candidates and the virus binding ligands where necessary. We continue
to work on creating the information needed for the development of controlled chemical synthesis procedures that is vital for developing
c-GMP manufacturing processes.
We are also making progress in development
of our cGMP manufacturing capability. The Company announced in May 2012 that it had appointed Mr. Andrew Hahn to help with the
overall design and construction of its laboratory and cGMP pilot production facility. Mr. Hahn recently retired as the Senior Director
of Engineering, Pharmaceutical Facilities, Global Engineering, at the Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS).
He has almost 30 years of experience in architecture, design and project management in the creation of new and refurbished facilities
at Bristol-Myers Squibb Company.
In addition, the Company announced on October
24, 2011, that information about its novel, proprietary anti-virus platform technology has been published in the book “Bionanotechnology
II: Global Prospects.” The chapter entitled “Nanoviricides - A Novel Approach to Antiviral Therapeutics” provides
an in-depth presentation of the NanoViricides platform technology.
The Company also announced in May 2012
that a fundamental patent, on which the nanoviricides® technology is based, is due to be issued in the USA on May 8, 2012.
The US Patent (No. 8,173,764) is granted for "Solubilization and Targeted Delivery of Drugs with Self-Assembling Amphiphilic
Polymers." It was issued on May 8, 2012. The patent term is expected to last through October 1, 2028, including anticipated
extensions in compensation for time spent in clinical trials. This US Patent has been allowed with a very broad range of claims
to a large number of families of chemical structure compositions, pharmaceutical compositions, methods of making the same, and
uses of the same. The disclosed structures enable self-assembling, biomimetic nanomedicines. NanoViricides, Inc. holds exclusive,
perpetual, worldwide licenses to these technologies for a broad range of antiviral applications and diseases. The other national
and regional counterparts of the international Patent Cooperation Treaty (“PCT”) application number PCT/US06/01820,
which was filed in 2006,. have issued as a Singapore National Patent Publication, a South African patent, and also as an OAPI regional
patent covering Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Republic of Congo, Cote d'Ivoire, Equatorial Guinea,
Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal, and Togo. It has also issued as a granted patent in New Zealand,
China, Mexico, and Japan. Estimated expiry dates range nominally from 2026 to 2028 with various extensions accounting for delays
in clinical trials. Additional issuances are expected in Europe, and in several other countries around the world.
In addition, the counterparts of the international
PCT application PCT/US2007/001607 have issued as a granted patent in New Zealand, OAPI, Pakistan, Australia, South Africa, and
Mexico to date. Additional issuances are expected in Europe, USA, and in several other countries around the world. This patent
application teaches antivirals based on the TheraCour polymeric micelle technologies, their broad structures and compositions
of matter, pharmaceutical compositions, methods of making the same, and their uses. The nominal expiry dates are expected to range
from 2027 to 2029.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATION
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 the Company's Annual Report on Form 10-K for the year ended June 30, 2013. 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 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.
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
The nanomedicine technologies developed
by TheraCour Pharma, Inc. serve as the foundation for our intellectual property. The Company holds 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. The Company has entered into an Additional License Agreement with TheraCour
granting the Company the exclusive licenses in perpetuity for technologies developed by TheraCour for the additional virus types:
Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Viruses causing viral Conjunctivitis (a disease of the eye) and Ocular
Herpes, and Ebola/Marburg viruses. The Company may want to add further virus types to its drug pipeline. The Company would then
need to negotiate with TheraCour an amendment to the Licensing Agreement to include those of such 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 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., the exclusive source for these nanomaterials. The Company may manufacture these drugs
itself, or 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. There can be no assurance that the Company will be able to enter into co-development or other
licensing agreements.
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. Several of the Company’s drug candidates have shown excellent levels of efficacy and preliminary
safety in animal studies in many different animal models against many different viruses. The Company determined that its anti-Influenza
program, “FluCide™”, was the most advanced and obtained and held a pre-IND meeting with the US FDA for the same
on March 29, 2012. The Company believes it has gained valuable guidance from the FDA that enables us to develop and execute a product
development plan for our anti-influenza drug candidate with the goal of filing an Investigational New Drug (IND) application to
the US FDA, and similar applications in other countries in the world.
As the Company’s drug candidates
progress towards human clinical studies, it has become necessary to enable that they can be produced under “current Good
Manufacturing Practices” (cGMP) guidelines of the US FDA, and other applicable international guidelines (such as WHO and
ICH guidelines, as well as other country-specific and region-specific guidelines). In the US, the US FDA requires that at least
two validated and consistent batches of the drug be produced under cGMP conditions before any human clinical trials can be allowed.
Some other countries may allow research product materials for certain phases of human clinical trials. The Company’s management
has studied the possibilities of contract manufacturing of its drug candidates over the last several years and has concluded that
building a small pilot scale manufacturing facility where the special needs of the manufacture of its nanomedicines can be met
is the most appropriate solution. This approach provides the highest level of control over the quality of the materials and also
keeps the intellectual property of the Company well protected. Further, to minimize capital costs to the Company, management determined
that a separate entity should be allowed to purchase the real estate, renovate, build and maintain the facilities under the Company’s
direction and control. Subsequently, a separate entity, Inno-Haven, LLC (“Inno-Haven”), controlled by Anil R. Diwan,
the Company’s founder, was created for this purpose. Inno-Haven purchased an 18,000 sq. ft. light manufacturing building
on a 4.2 acre land lot in Shelton, Connecticut in August, 2011. The purchase and related costs were financed by Dr. Diwan through
his personal savings, and the sale of NanoViricides common stock that he had acquired as a founder, that netted approximately $900,000
after expenses and income taxes. Dr. Diwan disposed of his shares in accordance with a 10b5.1 trading plan which concluded in October,
2011. Inno-Haven has also obtained additional financing from certain other unrelated parties.. Dr. Diwan had also agreed to provide
personal guarantees for potential loans and mortgages which could be drawn for the purpose of financing the building and construction
costs
The Company has agreed to provide Inno-Haven
the specifications and plans for the cGMP pilot facility and laboratory and office spaces that are anticipated to be built by renovating
the existing building. Subsequently, on February 11, 2013, the Company entered into a binding Memorandum of Understanding (“MOU”)
with Inno-Haven, to lease these facilities for a four-year term. The MOU is subject to a definitive lease agreement (the “Lease
Agreement”) to be executed upon final determination of the cost of the facilities. Pursuant to the MOU, the Company has agreed
to provide up to $2,000,000 in cash collateral for sums borrowed by Inno-Haven (collectively, the “Loans”) to complete
the build-out and renovation of the Leased Premises for the benefit of the Company. The Company agreed to file a registration statement
for the shares of restricted NNVC Common Stock owned and provided by TheraCour Pharma, Inc., as additional collateral for any or
all of the Loans (the “Registrable Shares”). The MOU further provides that, so long as there is no breach of the Lease
Agreement by the Company, any distribution of the collateral in accordance with a Loan will first be made from the proceeds of
life insurance policies (if applicable), then from the proceeds of the sale of the Registrable Shares, and then, should there be
any balance still owing to the lender, from the cash collateral. Also on February 11, 2013, pursuant to the provisions of the MOU,
the Company transferred $1,000,000 as cash collateral (the “Cash Collateral”) and agreed to register a number of shares
of the Company’s Common Stock, which shares were provided by TheraCour Pharma, Inc., equal to $1,000,000 (the “Collateral
Shares”) as collateral pursuant to a Loan and Security Agreement entered into between Inno-Haven and a non-affiliated lender
(the “Loan Agreement”) for a loan in the principal amount of $2,000,000. On September 17, 2013, the Company transferred
the remaining $1,000,000 cash collateral to Inno-Haven. Moreover, Inno-Haven is required to obtain a life insurance policy to insure
the life of Dr. Diwan in the amount of $2,000,000. If Dr. Diwan dies during the term of the Loan Agreement, the lender shall have
the option to demand payment of the balance of the loan, but, shall be repaid first from the proceeds of any life insurance policy
(if applicable), then from the proceeds of the sale of the Collateral Shares, and then, should there be any balance still owing
to the lender, from the Cash Collateral. As of December 31, 2013, the Company had expensed approximately $1.1 million in specific
fixtures and improvements required by the Company. No lease has been finalized as of now. Total rent expense paid to Inno-Haven
during this period amounted to $-0- for the three months ended December 31, 2013 and $-0- since February 11, 2013.
The Company does not currently have any
revenue. All of the Company’s products are in development stage and require successful; development through regulatory processes
before commercialization. During the development stage, we have generated funding through the issuances of debt and private placement
of common stock and also the sale of our registered securities. The Company does not currently have any long term debt, other than
convertible debentures as disclosed earlier. We have not generated any revenues and we may not be able 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.
The Company’s Drug Pipeline
We currently have, in early, active development,
(1) an Injectible FluCide™ for hospitalized patients with severe influenza; (2) Oral FluCide™ for outpatient –
both of these drug candidates are expected to be active against Epidemic Influenzas including the current novel H1N1/2009 “Swine
flu” virus, H5N1 and other Highly Pathogenic Avian Influenzas (H5N, H7N, H9N HPAI, Bird Flu), as well as common seasonal
human Influenzas; (3) HIV Cide, a potential “Functional Cure that is active against both the R5 and X4 strains of HIV, (4)
Eye drops against viral diseases of the eye such as Epidemic Kerato-Conjunctivitis (EKC) and Herpes Keratitis, (5) HerpeCide against
Herpes virus cold sores and genital Herpes, and (6) DengueCide against Dengue viruses. In addition, we have research programs against
Rabies virus, Ebola/Marburg family of viruses, as well as other Viral hemorrhagic fevers. We also have a research program called
ADIF(™) “Accurate-Drug-In-Field”, that we believe is the only way to combat a novel viral threat right in the
field before it becomes an epidemic like SARS, bird flu H5N1, Ebola, or other viral outbreak. Adenoviral Epidemic Kerato-Conjunctivitis
(EKC) is a severe pink eye disease that may lead to blurry vision in certain patients after recovery. Herpes simplex viral infections
cause keratitis of the eye, and severe cases of infection may sometimes necessitate corneal transplants. 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. However, there can be
no assurance that TheraCour will agree to license these materials to the Company, or to do so on terms that are favorable to the
Company.
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 of 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.
Requirement for Additional Capital
As of December 31, 2013, we have current
assets of $19.2M that is more than sufficient our operations through more than two years or December 31, 2015, at the Company’s
current rate of expenditure. In addition, subsequent to the reporting period, we have raised approximately $20M gross (or approximately
$18.8M after commissions).
While we now have the necessary funds based
on our current operations to last more than the next 24 months, we anticipate undertaking additional expenditures to accelerate
our progress to regulatory submissions. With our current funds we believe that we currently have sufficient funding available to
perform Toxicology Package studies, and additional animal efficacy studies, to move at least one of our drug candidates into an
Investigational New Drug Application (“IND”) with the US FDA or a similar application with an international regulatory
agency, and to conduct Phase I and Phase IIa human clinical trials of at least one of our drug candidates. In order to file an
IND application, we also need to enable manufacturing of the drug under US FDA guidelines called cGMP. We estimate that a small,
1kg/batch, production facility would be sufficient to satisfy the Company’s near future needs for supporting the FluCide
clinical studies, at least through Phase II. This small batch size requirement is based on the extremely high effectiveness of
the influenza clinical candidate observed in animal studies, and therefore must be treated with caution. We intend to
enter into lease negotiations with Inno-Haven, LLC (“Inno-Haven”) to enable cGMP manufacture of our drug products.
Inno-Haven is managed by its member Dr. Anil R. Diwan, who is our President and Chairman. Inno-Haven raised financing from Dr.
Diwan and others, including some earlier investors of NanoViricides, Inc., and is renovating an 18,000 square foot building in
Shelton, CT, on a 4.2 acre lot. Dr. Diwan raised additional financing through the sale of his NanoViricides stock that
he had obtained as a founder under a 10b5-1 plan that was concluded in October, 2011. Inno-Haven has also raised significant amounts
of additional financing through affiliated and un-affiliated parties. A lease agreement has not been completed , but the parties
have negotiated a Memorandum of Understanding which will form the basis of the lease terms.
We anticipate that as we progress with
our first drug candidate, we may need an additional $10M to $15M to take one of our drug candidates through certain phases of human
clinical trials. Further additional funding, if available, will allow us to move our other drug candidates towards IND
filings. These additional funds will be needed to pay for additional personnel, increased subcontract costs related to the expansion
and further development of our drug pipeline, and for additional capital and operational expenditures required to file IND applications.
We will accelerate our business plans provided that we can obtain such additional funding. We believe that we currently have adequate
financing for our current business plan of operations.
We anticipate that we will incur the following
additional expenses over the next 24 months.
1. Research and Development of $5,000,000:
Planned costs for in-vivo and in-vitro studies for pan-influenza FluCide, Eye nanoviricide, HIVCide, HerpeCide, Dengue, and Ebola/Marburg
and Rabies programs.
2. Corporate overhead of $1,500,000: This
amount includes budgeted office salaries, legal, accounting, investor relations, public relations, and other costs expected to
be incurred by being a public reporting company.
3. Capital costs of $1,500,000: This is
the estimated cost for equipment and laboratory improvements.
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, and other items related to FDA compliance, as required for development
of necessary data for filing an Investigational New Drug with the United States Food and Drug Administration.
In addition the Company anticipates estimated
capital costs of $4,000,000 for infrastructure and laboratory facilities for a scaled up research pilot production facility. The
Company anticipates that some of this infrastructure funding will be obtained through real estate and industrial loans and related
instruments. Further, we estimate approximately $5,000,000 will be needed to take our first drug candidate through Phase I and
Phase IIa human clinical trials.
Subsequent to the reporting period, we
have raised approximately $20M gross (or approximately $18.8M after commissions). With these additional funds, the Company is now
in a position to be able to advance at least one more additional drug candidate towards human clinical trials, and possibly also
conduct initial human clinical trials for this additional candidate. Our projections are based on several assumptions and preliminary
quotations from providers of various services. The Company does not have direct experience in taking a drug through human clinical
trials. In addition, we depend upon external collaborators, service providers and consultants for much of our drug development
work. As such our projections and estimates may be significantly off from actual future results both in terms of timeline and in
terms of cost budgets.
In March, 2010, the Company filed a Form
S-3 Shelf Registration with the Securities and Exchange Commission (SEC) for the sale from time to time of up to $40 million of
the Company’s securities. The registration statement became effective on April 29, 2010. As of December 31, 2012,
the Company had drawn down $22,500,000 of the $40,000,000 S-3 Shelf Registration. In addition, on October 26, 2012, the Company
has filed a new S-3 Shelf Registration Statement for $40,000,000 of common stock, preferred stock, warrants, debt securities and
units comprised of those securities. Subsequently we combined the unused portion of the prior shelf registration for a total available
Shelf Registration of $57,500,000. As of December 31, 2013, the Company has drawn down approximately $35,000,000 from this shelf
registration. Subsequently, on January 21, 2014, the Company completed another registered direct offering based on this shelf and
an additional allowance of 20%, to raise $20M and exhausting the registered shelf. The Offering was made pursuant to the Company’s
shelf registration statement on Form S-3 (File No. 333-184626), which was declared effective by the Securities and Exchange Commission
on December 21, 2012 and Form S-3MEF (File No. 333-193439). The Company, pursuant to Rule 424(b) under the Securities Act of 1933,
has filed with the Securities and Exchange Commission a prospectus supplement relating to the Offering.
With these funds, in addition to certain
clinical trials for FluCide and DengueCide, the Company anticipates that it will also be able to expedite development of its four
other drug candidates, namely, Oral FluCide, HerpeCide™, HIVCide™, and EKCCide™ into the FDA approval process.
The Company anticipates it will have sufficient
access to capital even if it decides to develop FluCide through Phase III on its own. The Company believes it will continue to
be able to successfully raise financing as needed. If we are unable to obtain additional financing, our business plan will be significantly
delayed.
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.
We believe that our current work-plan will
lead us to obtain certain information about the safety and efficacy of some of the drugs under development in animal models. If
our studies are not successful, we will have to develop additional drug candidates and perform further studies. If our studies
are successful, then we expect to be able to undertake further studies in animal models to obtain necessary data regarding the
pharmaco-kinetic and pharmaco-dynamic profiles of our drug candidates. We believe these data will then enable us to file an Investigational
New Drug (IND) application, towards the goal of obtaining FDA approval for testing the drugs in human patients.
Most pharmaceutical companies expect 4
to 10 years of study to be required 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 most of our studies will be of relatively short
durations. Our business plan is based on these assumptions. If we find that we have underestimated the time duration of our studies,
or we have to undertake additional studies, due to various reasons within or outside of our control, this will grossly and adversely
impact both our timelines and our financing requirements.
Management intends to use capital and debt
financing, as required, to fund the Company’s operations. Management also 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 beyond December
31, 2015. The Company currently has no long term debt other than the convertible debentures as disclosed.
The Company is considered to be a development
stage company and will continue in the development stage until it generates revenues from the sales of its products or services.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK.
Market risk is the
risk of loss arising from adverse changes in market rates and prices, such as interest rates, foreign currency exchange rates and
commodity prices. We currently have no foreign operations and are not exposed to foreign currency fluctuations. Our primary exposure
to market risk is interest rate risk associated with our short term cash equivalent investments, which the Company deems to be
non-material. The Company does not have any financial instruments held for trading or other speculative purposes and does not invest
in derivative financial instruments, interest rate swaps or other investments that alter interest rate exposure. The Company does
not have any credit facilities with variable interest rates.
ITEM 4. CONTROLS AND PROCEDURES
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(a)
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Evaluation of disclosure controls and procedures.
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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.
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 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, 2013.
(a) Based upon an evaluation of the effectiveness
of disclosure controls and procedures, our Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO")
have concluded that as of the end of the period covered by the Annual Report on Form 10-K our disclosure controls and procedures
(as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) were effective to provide reasonable assurance that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified
by the rules and forms of the SEC and is accumulated and communicated to management, including the CEO and CFO, as appropriate
to allow timely decisions regarding required disclosure.
(b) Changes in internal control over financial
reporting. The Company has established an independent Board of Directors comprising three independent members. Under this Board
the Company has established an Audit Committee, a Compensation Committee, a Nomination Committee, and an Executive Committee. The
Company has met or exceeded corporate governance standards of the NYSE MKT, a national exchange. On September 25, 2013, the Company’s
common stock was listed and began trading on the NYSE MKT.
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.
Management conducted an evaluation of the
effectiveness of our internal control over financial reporting as of June 30, 2013. 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 (the “COSO Framework”). Based on its evaluation
under the
Internal Control - Evaluation Framework,
management concluded that our internal control over financial reporting
was effective as of June 30, 2013.
Changes in Internal Control Over Financial
Reporting
In June 2013, the Company completed the
process of accomplishing an independent board of directors. Simultaneously, the Company also expanded its Audit Committee, chaired
by its Director, Mr. Stanley Glick, CPA, to include two additional Board Members, namely, Professor Mukund Kulkarni and Professor
Dr. Milton Boniuk. In addition, the Company formalized its Compensation Committee, and Nomination Committee, with the same three
independent board members serving on these committees. The Company further formulated an Executive Committee that reports directly
to the Board of Directors. The Company’s CEO, Dr. Eugene Seymour, MD, MPH, and its President, Anil R. Diwan, PhD, are ex-officio
members of the Executive Committee.
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 December 31, 2013, that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we may be a party to
legal proceedings in the ordinary course of our business in addition to those described below. We do not, however, expect such
other legal proceedings to have a material adverse effect on our business, financial condition or results of operations.
On or around January 18, 2012, the Nevada
Agency and Transfer Company, as agent for service of process for the Company in Nevada, was served with a Summons and Complaint
in the case entitled Yidam, Ltd. v. Eugene Seymour, Anil Diwan, and NanoViricides, Inc. (Case No. A-12-654437-B) answerable in
the Eighth Judicial District Court of the State of Nevada – Clark County (“Court”). The Complaint seeks
to compel inspection of the Company’s books and records. On or about February 14, 2012 we filed a Motion to Dismiss
the Complaint for failure to state a claim upon which relief can be granted. The Complaint further seeks unspecified “injunctive
relief” in furtherance of the demand for inspection to which it is not entitled. The Complaint by a holder of less
than 1 percent of the common stock of the Company seeks to, inter alia, inspect documents and records of the company to which it
is not entitled and in a form and manner the Company argues is not authorized by statute. Management believes that this lawsuit
has no merit or basis and intends to vigorously defend it. Monetary damages have not been claimed and as a result no accrual
has been made in relation to this litigation. On April 9, 2012, the Court dismissed the Complaint for failure to state a Claim
for which relief could be granted.
On or about April 13, 2012, the Nevada
Agency and Transfer Company, as agent for service of process for the Company in Nevada, was served with a Summons and Complaint
in the case entitled Yidam, Ltd. v. Eugene Seymour, Anil Diwan, and NanoViricides, Inc. (Case No. A-12-659535-B) answerable in
the Eighth Judicial District Court of the State of Nevada – Clark County (“Court”). The Complaint seeks to compel
inspection of the Company’s books and records. On or about May 2, 2012, the Company filed a Demand for Security of Costs.
Upon filing of the Demand, proceedings relative to the Company are stayed pending posting of the demanded security (or plaintiff
engages in motion practice about the Demand). The Company may seek dismissal of the complaint if plaintiff has not posted the demanded
security (or engaged the court). The Complaint further seeks unspecified “injunctive relief” in furtherance of the
demand for inspection to which the Company believes it is not entitled. The Complaint, by a holder of less than 1 percent of the
common stock of the Company, seeks to, inter alia, inspect documents and records of the company to which it is not entitled and
in a form and manner the Company argues is not authorized by statute. On or about July 18, 2012, the Plaintiff moved to amend its
answer. On or about August 8, 2012, we filed our opposition to Plaintiff’s Motion to Amend and a Motion to Dismiss the Complaint
for failure to state a claim upon which relief can be granted. On or about September 13, 2012 the court granted the Plaintiff’s
Motion to Amend. On or about September 17, 2012 the Plaintiff served its “Second Amended Shareholder Derivative Complaint”
upon our Counsel in Nevada. As in the prior two complaints that this Plaintiff has filed in this action, the Second Amended Complaint
sought to compel inspection of the Company’s books and records, sought injunctive relief, an accounting and alleges breach
of Fiduciary by Dr. Seymour and Dr. Diwan. On or about October 11, 2012, we filed a Motion to Dismiss the Second Amended Complaint
for failure to state a claim upon which relief can be granted. On or about December 4, 2012, the Court granted the Company’s
Motion to Dismiss with respect to Dr. Seymour and Dr. Diwan and ordered the case dismissed as to all claims but the Plaintiff’s
request to compel documents required to be maintained by the Company’s registered agent in Nevada pursuant to NRS 78.105.
On or about December 26, 2012, the Company provided the Plaintiff with each of the documents to which it is entitled. Management
believes that the Plaintiff does not have a legal or good faith basis for inspection or copying of its shareholder’s list
and intends to vigorously defend the production thereof. In May, 2013, the Plaintiff filed a motion for permission to file a third
amended complaint. The Company subsequently filed a motion to dismiss and for Summary Judgment. The Court denied the Motion to
Dismiss and for Summary Judgment and ordered the Plaintiff to file its Third Amended Complaint. On or about July 15, 2013 the Company
Petitioned the Nevada Supreme Court for a Writ of Prohibition or Mandamus reversing the trial Court’s denial of Summary Judgment.
Thereafter, on or about September 20, 2013, the Nevada Supreme Court denied the Company’s Writ Petition. The Company filed
its answer to the Third Amended Complaint, which contains only one cause of action which is identical to the sole cause of action
which was not dismissed from the Second Amended Complaint. Specifically, the Third Amended Complaint seeks only to compel production
of books and records required to be maintained by the Company’s Registered Agent pursuant to NRS 78.105 Management believes
that the Company’s registered Agent has provided the Plaintiff with all documents to which it is entitled pursuant to NRS
78.105 and that this lawsuit has no merit or basis. The Company intends to vigorously defend this lawsuit. Specific monetary damages
have not been claimed and as a result no accrual has been made in relation to this litigation.
On or about July 15, 2013 the same Plaintiff
that had filed the repetitive complaints in the Nevada action as set forth in the preceding paragraph (Yidam, Ltd. v. Eugene Seymour,
Anil Diwan, and NanoViricides, Inc.)filed a Shareholder Derivative complaint with the United States District Court for the District
of Colorado . The Plaintiff asserts the action is a shareholder derivative action and the Company is solely a nominal defendant.
The Company maintains that it, as well as the individual defendants, Messrs. Seymour and Diwan, have not been served in the action.
However, a default had been filed against the Company, which has been vacated. The Complaint alleges that the Company has failed
to deliver information requested by the Plaintiff, the identical information the Plaintiff is seeking inspection of in the Nevada
action, and that the individual defendants, Messrs. Seymour and Diwan, breached their fiduciary duties to the Company and caused
it financial harm. The Plaintiff demands an order to inspect the Company’s records, an order revoking Messrs. Diwan
and Seymour from the Board of Directors, equitable relief, and consequential and punitive damages. The Company believes these
claims have no merit and the Company intends to defend this action vigorously. The Company has moved the District Court to dismiss
the action in its entirety. Though consequential and punitive damages are claimed, no facts have been submitted to support such
claim. Management has determined that such claims are specious and not relevant to the Company and no accrual has been made in
relation to this litigation.
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 2. UNREGISTERED SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS.
In September, 2013, the Company’s
Board of Directors authorized the issuance of Warrants to Midtown Partners & Co., LLC and Chardan Capital Markets, LLC (collectively,
the “Placement Agents”) to purchase a total of 58,910 shares of common stock at $5.25 per share expiring in September,
2018. These warrants were valued at $113,696 and recorded as Placement Agents Fees related to the sale of Common Shares
and Warrants on September 10, 2013.
For the three months ended September 30,
2013, the Company's Board of Directors authorized the issuance of 10,311 shares of its common stock with a restrictive legend for
consulting services. The Company recorded an expense of $21,000.
For the three months ended September 30,
2013, the Company's Board of Directors authorized the issuance of 5,501 shares of its common stock with a restrictive legend for
Director services. The Company recorded an expense of $11,250.
In November, 2013, the Scientific Advisory
Board (SAB) was granted warrants to purchase 17,143 shares of common stock at $6.56 per share expiring in November ,2017. These
warrants were valued at $31,552 and recorded as consulting expense.
In December, 2013, the Company issued 7,143
shares of the Company’s $0.001 par value Common Stock with a restrictive legend at $3.50 per share upon the exercise of Warrants.
For the three months ended December 31,
2013, the Company's Board of Directors authorized the issuance of 4,069 shares of its common stock with a restrictive legend for
consulting services. The Company recorded an expense of $21,000.
For the three months ended December 31,
2013, the Company's Board of Directors authorized the issuance of 2,220 shares of its common stock with a restrictive legend for
Director services. The Company recorded an expense of $11,250.
The securities described above were offered
and sold in reliance upon exemptions from registration pursuant to Section 4(2) under the Securities Act and Rule 506 of Regulation
D promulgated thereunder. The agreements executed in connection with this sale contain representations to support the Registrant’s
reasonable belief that the Investor had access to information concerning the Registrant’s operations and financial condition,
the Investor acquired the securities for their own account and not with a view to the distribution thereof in the absence of an
effective registration statement or an applicable exemption from registration, and that the Investor are sophisticated within the
meaning of Section 4(2) of the Securities Act and are “accredited investors” (as defined by Rule 501 under the Securities
Act). In addition, the issuances did not involve any public offering; the Registrant made no solicitation in connection with the
sale other than communications with the Investor; the Registrant obtained representations from the Investor regarding their investment
intent, experience and sophistication; and the Investor either received or had access to adequate information about the Registrant
in order to make an informed investment decision. The Company has not utilized an underwriter for an offering of its
securities, except in the recent financing completed on September 10, 2013 with various investors, wherein Midtown Partners &
Co., LLC and Chardan Capital Markets, LLC (collectively, the “Placement Agents”) were engaged as placement agents for
the Company’s securities sold in the offering.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Dr. Krishna Menon, our interim Consulting
Regulatory Officer, has resigned from this consulting post due to health reasons. Dr. Menon was not an employee of the Company
and did not receive any compensation for this role, other than the shares of founder’s stock he had received at the formation
of the Company. Randall W. Barton, PhD, our Chief Scientific Officer (CSO), continues to perform the duties of our interim Regulatory
Officer. He is supported in this role by the Biologics Consulting Group, Inc., our consultants for regulatory affairs.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibit index
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Exhibit
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31.1
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Certification of Chief Executive and Interim Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
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32.1
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Certification of Chief Executive Officer and Interim Chief Financial Officer required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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(b) Reports on Form 8-K. During the fiscal
quarter ended December 31, 2013, the Company filed the following Current Reports on Form 8-K:
On December 13, 2013, the Company filed
a Current Report on Form 8-K disclosing that the Company held its Annual Meeting on December 9, 2013 and that at the Meeting, the
Company’s stockholders: (i) re-elected Eugene Seymour, as director of Class II for a two-year term expiring at the 2015 annual
meeting of stockholders and until his successor is duly elected and qualified or until his earlier resignation or removal; (ii)
voted, on an advisory basis, on the compensation of the Company’s named executive officers; (iii) voted, on an advisory basis,
on a three year frequency to approve the compensation of the Company’s named executive officers; (iv) ratified the appointment
of Li & Company, P.C. as the Company’s independent registered public accounting firm for the fiscal year ending June
30, 2014. Each proposal is described in more detail in the Company’s Proxy Statement filed with the Securities and Exchange
Commission on October 22, 2013.
SIGNATURES
Pursuant to the requirements of Section
13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Dated: February 14, 2014
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NANOVIRICIDES, INC.
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/s/ Eugene Seymour, MD
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Name: Eugene Seymour, M.D.
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Title: Chief Executive Officer and Director
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(Principal Executive Officer )
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/s/ Meeta Vyas
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Name: Meeta Vyas
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Title: Chief Financial Officer
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(Chief Financial Officer)
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