10-K
1
tm2124471d1_10k.htm
FORM 10-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
x ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED JUNE 30, 2021
NANOVIRICIDES, INC.
(Name of Business Issuer in Its Charter)
1 CONTROLS DRIVE, SHELTON, CONNECTICUT, 06484
(Address of principal executive offices)
203-937-6137
(Issuer’s telephone number, including area
code)
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF
THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF
THE ACT:
COMMON STOCK, PAR VALUE $0.001 PER SHARE NYSE AMERICAN
(Title of Class) (Name of exchange on which registered)
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ̈ No x
Indicate by a check mark if the registrant is
not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ̈ No x
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days.
Yes x No ̈
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted 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 registrant was required to submit such files).
Yes x No ̈
Indicate by check mark if disclosure of delinquent
filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge,
in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. x
Indicate by check mark whether the Company is
a larger accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See
the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ̈ Accelerated filer ̈
Non-accelerated filer x Smaller reporting company x
Emerging growth company ̈
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ̈
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act.).
Yes ̈ No x
As of October 12, 2021, there were approximately
11,515,000 shares of common stock of the registrant issued and outstanding.
The aggregate market value of the voting
stock held on December 31, 2020, by non-affiliates of the registrant was approximately $29,660,000 based on the closing price
of $2.94 per share, as reported on the NYSE American on December 31, 2020, the last business day of the registrant’s most
recently completed fiscal second quarter (calculated by excluding all shares held by executive officers, directors and holders known
to the registrant of five percent or more of the voting power of the registrant’s common stock, without conceding that such
persons are “affiliates” of the registrant for purposes of the federal securities laws).
TABLE OF CONTENTS
PART I
Item 1. Business 3
Item 1A Risk Factors 61
Item 1B Unresolved Staff Comments 84
Item 2. Properties 84
Item 3. Legal Proceedings 84
Item 4. Mine Safety Disclosures 84
PART II
Item 6. Selected Financial Data 90
Item 7A Quantitative and Qualitative Disclosures About Market Risk 105
Item 8. Financial Statements and Supplementary Data 105
Item 9A. Controls and Procedures 105
Item 9B. Other Information 107
PART III
Item 10. Directors, Executive Officers, Promoters and Corporate Governance. 107
Item 11. Executive Compensation 110
Item 14. Principal Accountant Fees and Services 118
PART IV
Item 15. Exhibits, Financial Statement Schedules 119
Page 2 of 121
PART I
SPECIAL NOTE ON FORWARD-LOOKING STATEMENTS
The information in this report contains forward-looking
statements. All statements other than statements of historical fact made in 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,”
“designed to,” “designed for,” 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 1: BUSINESS
Organization and Nature of Business
NanoViricides, Inc. (the “Company”,
“NanoViricides”, “we,” or “us”) was incorporated in Nevada on April 1, 2005. Our corporate offices
are located at 1 Controls Drive, Shelton, Connecticut 06484 and our telephone number is (203) 937-6137. Our Website is located at http://www.Nanoviricides.com.
We do not incorporate by reference into this Annual Report the information on or accessible through our website, and you should not consider
it part of this Annual Report.
On September 25, 2013, the Company’s
common stock began trading on the New York Stock Exchange American under the symbol, “NNVC”.
We are a development stage company with several
drugs in various stages of pre-clinical development, including late stage IND-enabling non-clinical studies. We have no customers, products
or revenues to date, and may never achieve revenues or profitable operations.
We have several drugs in our pipeline. Of these,
two drugs developed to combat the COVID-19 pandemics, namely NV-CoV-2 and NV-CoV-2-R, are our most advanced drug candidates. We
are currently working on taking these two COVID-19 lead drug candidates into human clinical trials. We believe that the essential preclinical
work including GLP Safety/Toxicology studies is substantially complete for taking these drugs into human evaluation. We plan on undertaking
further clinical advancement of our other lead drug candidate, NV-HHV-101 skin cream for the treatment of shingles, after the COVID-19
program completes initial human clinical studies. The essential preclinical work including GLP Safety/Toxicology studies of NV-HHV-101
were completed and we were beginning to assemble a draft IND application just when the global COVID-19 pandemic struck. We continued to
work on NV-HHV-101 until we had developed viable drug candidates against COVID-19, circa May/June 2020, and thereafter focused completely
on the COVID-19 drug development, putting the NV-HHV-101 program on hold.
Page 3 of 121
We also have several additional pre-clinical drug
development programs including Herpes Simplex Viruses (HSV-1 that causes cold sores, and HSV-2 that causes genital ulcers), HIV/AIDS,
Influenza, Dengue viruses, and Ebola/Marburg, which plan to advance further towards clinical drug candidates as we progress further. Thus
we have a strong and broad pipeline that is expected to continue to result in highly effective drug candidates against a number of viral
diseases.
NanoViricides is one of a few biopharma companies
that has its own cGMP-compliant manufacturing facility. The Company intends to produce its drugs for clinical trials in this facility.
The Company has the capability to produce sufficient drugs for about 1,000 patients in a single batch of production, depending upon dosage.
This production capacity is anticipated to be sufficient for first-in-human use in the current SARS-CoV-2 pandemic for our anti-coronavirus
drug in development, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles.
NanoViricides is one of a few biopharma companies that has its own
cGMP-compliant manufacturing facility. We intend to produce our drug substances, and in many cases, our drug products as well, for clinical
trials in this facility. We have the capability to produce sufficient drugs for about 1,000 patients in a single batch of production,
depending upon dosage. This production capacity is anticipated to be sufficient for first-in-human use in the current SARS-CoV-2 pandemic
for our anti-coronavirus drugs in development, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment
of shingles.
We would like to note that in response to
the current global COVID pandemic, the scientific community at large and regulatory efforts to date have remained focused on (a)
vaccines, (b) antibodies, and (c) re-development of pre-existing drugs. Even as alarm bells were raised by renowned scientists
regarding the likelihood of escape mutations and the limitations of any vaccines and antibody therapies in combating a rapidly
evolving global viral pandemic, there has been an effort to downplay these risks at all levels. This has left the world now
grappling with a situation where vaccines are being rolled out even as virus variants that are highly likely to be resistant to
current vaccines and antibody drugs have already been found to be spreading rapidly. Current vaccines are now assumed to require
constant updates and/or re-inoculation campaigns (aka “booster shots”) to keep up with ongoing changes in the virus.
Attention needs to be focused instead on broad-spectrum antiviral therapeutics that minimize the possibility of virus variants
escaping the drug, thereby making the costly ongoing development of vaccine updates, their deployment and re-inoculation campaigns,
unnecessary.
We believe that our platform technology enables
development of drugs that viruses would not escape from. In fact, we have successfully screened our COVID-19 drug candidates to be able
to protect cells against infection by distinctly different coronaviruses. This broad-spectrum drug development approach was adopted to
ensure that our drug candidates should remain effective even as future variants of SARS-CoV-2 evolve in the field, as was already anticipated
by us at the very beginning of the pandemic.
Additionally, ours is the only company that, to
the best of our knowledge, is developing antiviral treatments that are designed to (a) directly attack the virus and disable it from infecting
human cells, and (b) simultaneously block the reproduction of the virus that has already gone inside a cell. Together, this strategy of
a two-pronged attack against the virus, both inside the cell and outside the cell, can be expected to result in a cure for coronaviruses
and other viruses that do not become latent.
The Company’s nanoviricides® platform
technology is based on biomimetic engineering that copies the features of the human cellular receptor of the virus. No matter how much
the virus mutates, all virus variants bind to the same receptor in the same fashion. It appears that the later variants of SARS-CoV-2
may have evolved to bind to the human cellular receptor ACE2 more strongly, in general, based on published datasets. Thus, if these features
of the cellular receptor are appropriately copied, the resulting nanoviricide drug would remain effective against current and future variants
of the virus.
Our current drug candidates to combat the COVID-19
pandemic are designed to attack not only SARS-CoV-2 and its current and future variants, but also many other coronaviruses, and will be
useful even after the pandemic is over, since several coronaviruses are endemic in human populations. SARS-CoV-2 with its variants and
substantial penetration into human populations worldwide is on course to become an endemic virus.
Page 4 of 121
Our COVID-19 drug candidates successfully entered
core safety pharmacology studies required prior to commissioning human clinical trials around October/November, 2019. These studies have
now been completed and we have received the GLP Safety/Toxicology reports from the external CRO in August 2021. We are now engaged in
the preparation of clinical trial protocols and other activities that would be necessary for filing of an IND with the US FDA or equivalent
regulatory filings for entering into human clinical trials in other countries.
The need for the broad-spectrum nanoviricide SARS-CoV-2
drug cannot be overstated in the current circumstances and the present status of the pandemic. To understand this, we are providing a
short review of the current state of the pandemic below:
Strong government support led to rapid emergency
use approval, and later full approval, of an already known antiviral drug now called Veklury (Remdesivir, Gilead) early on. Strong fiscal
support and regulatory enablements from the government also led to the emergency use approval of two different antibody drugs, one from
Regeneron (REGN-CoV-2, a monoclonal antibody cocktail containing two different antibodies) and one from Eli Lilly (bamlanivimab,
a single antibody for restricted use) in the fastest ever drug development timeframe. All of these antibody drugs target the viral Spike
protein that binds to the human cellular receptor, ACE2.
Even stronger commitments and strong government
support led to the fastest ever emergency use approval of two vaccines, both employing nanotechnology: one by Pfizer-BioNTech, and
one by Moderna. Subsequently, additional vaccines have been approved in various countries and several are in development. Almost all of
these vaccines target the original 2019-nCoV-Wuhan variant, and all but a few target primarily its Spike protein.
Yet, as the vaccines are being deployed, several
new virus variants of tremendous concern have already emerged. Additional virus variants will continue to emerge at an even faster rate
because of the widespread dissemination of the virus with many patient bodies serving as virus factories providing historically the greatest
ever opportunities for the virus to escape existing vaccines and antibody drugs. It has already been found that as new variants emerge,
the effectiveness of the antibody drugs against the new variants is diminishing rapidly. Failure of vaccines and antibody drugs is therefore
certain; the only question is how long will it be before the vaccines become substantially ineffective.
Replacing current vaccines with a new vaccine,
as has been suggested, would be an endless game of chasing a rapidly changing epidemic that would be costly and also would remain substantially
non-responsive to the threat, since the virus will continue to remain many steps ahead of the vaccine. Giving booster doses of existing
vaccines repeatedly is both scientifically and epidemiologically or ethically unsupportable except for specific subsets of populations
that do not respond to the vaccine without multiple boosters.
It is well known that viruses, particularly RNA
viruses, mutate rapidly, and that such changes produce “variants” that can escape from vaccines as well as from antibody drugs.
SARS-CoV-2 has a repair mechanism that retains some fidelity during reproduction, and therefore it changes less rapidly than Influenza
A viruses or HIV. Nevertheless, given the significant penetration of the virus into human population, and the very high viral loads achieved
in severe cases of the infection, the virus has a huge opportunity to change. Additional virus variants will undoubtedly continue to emerge
at an even faster rate because of the widespread dissemination of the virus through many patients, their bodies effectively serving as
“factories”. This important concern, voiced by several eminent scientists, has not been regarded with the seriousness it deserves
by supporting and enabling rapid regulatory development of broad-spectrum drugs targeted at the coronaviruses.
The world has already witnessed at least five
important SARS-CoV-2 variants with significant impact, as a result of the large number of persons becoming infected. The very first important
variant, namely D614G, replaced the original Wuhan strain completely and rapidly during the first wave of the pandemic itself. In the
second wave, we have seen emergence of the lineage B.1.1.7 variant from United Kingdom (Kent and London; now called alpha variant), the
N501Y-V.2 (also called lineage B.1.351) from South Africa, and the P.1 variant (also called lineage B.1.1.248) from Brazil. California
has seen lineage B.1.429 /(CAL.20C) variant become dominant in Los Angeles county recently, with over 50% of the infections. It appeared
to be replacing the earlier dominant CAL.20G variant.
Page 5 of 121
The delta variant from India has replaced the
alpha variant almost globally and has caused a new widely spread and severe wave of infections. Several additional variants have been
identified. New variants continue to be identified at a rapid pace as viral genome sequencing efforts are accelerated.
A major concern is the fact that the variants
that are now becoming dominant have an accumulation of multiple mutations. This is predictive of such variants being more resistant to
drugs and vaccines in use. These variants are likely to have been selected against drug pressure or immune system pressure, and thus would
likely have resistance to vaccines, antibody drugs, as well as other commonly used drugs, as suggested by eminent scientists. Further,
it is now well known that some of the new variants can cause infection of a previously recovered coronavirus patient, as well as previously
vaccinated persons, and sometimes may lead to more severe disease than the earlier infection. Such new variants can be logically expected
to be resistant to antibodies as well as vaccines. Additionally, it has already been found or suspected that many of the new variants
are or are expected to be increasingly resistant to existing antibody drugs. Given the known weak effectiveness of available antibody
drugs, even a small resistance would likely allow a variant to escape the current antibody drugs.
Of note, the currently approved drugs, namely remdesivir, the Regeneron
antibody cocktail, or the Eli Lilly single antibody drug, had demonstrated only moderate effectiveness in clinical trials. Remdesivir
reduced the length to recovery in severe disease cases in hospitalized patients by approximately six days, from 18 days to 12 days in
a clinical trial, NIAID ACIT-1, as reported in its European (CHMP) Product Information. The Regeneron drug dosing in a clinical trial
was at 2.4g or 8g of total antibody, while the Eli Lilly antibody drug dose in the combination therapy clinical trial was at 5.6g, although
single antibody therapy dosages from 700mg upwards are also being evaluated. These high dosage levels are indicative of relatively weak
effectiveness. The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Regeneron REGEN-COV cocktail,
and also to an Eli Lilly single antibody bamlanivimab (LY-CoV555) with both authorizations restricted to the treatment of mild to moderate
COVID-19 only. Thus, further loss of effectiveness of the existing drugs as new variants emerge would have devastating consequences.
Vaccines, it is now clearly apparent, are neither
the great hope nor panacea that the scientific community had once projected them to be for this pandemic. The South African variant, 501Y.v2
is of great concern as scientists believe it may escape current vaccines. Its mutations are also shared by the Brazilian variant, P.1.
Vaccinated persons coming down with SARS-CoV-2 infection has already been witnessed. As more variants emerge, existing vaccines would
very likely lose effectiveness. An additional concern is that some of the variants are expected to result in greater total fatality numbers.
A more contagious variant would cause more number of cases and thus greater number of fatalities. A more lethal variant would lead to
a greater proportion of infected patients dying (i.e. a greater case fatality rate). The UK B.1.1.7 (alpha) variant is currently estimated
by the UK scientific advisory body, namely New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), to be highly contagious
(transmissible), infectious, and more lethal than previous variants. The Delta variant is estimated to be far more contagious than the
alpha variant.
Fiscal Year 2020-2021 in Review
The SARS-CoV-2 virus, despite its current and
future variants, is extremely unlikely to escape a broad-spectrum anti-coronavirus drug like the drugs NV-CoV-2 and NV-CoV-2-R that we
are developing. This is in complete contrast with drugs based on antibodies, antibody cocktails, as well as with preventative vaccines.
We have been developing broad-spectrum anti-coronavirus
drug candidates since the early reports of the new virus from China, then known as 2019-nCoV. We were able to bootstrap this development
using our knowledge gained in the earlier endeavors working on SARS-CoV-1 and MERS coronaviruses.
We have been able to conduct this novel drug development
at an accelerated pace because of the benefits of our platform technology. We were able to bootstrap our SARS-CoV-2 drug development efforts
using the c-GMP-compatible manufacturing processes developed for our then flagship NV-HHV-101 drug candidate for shingles dermal treatment.
Further, we have a tremendous advantage in that the Company has its own cGMP-capable manufacturing facility in Shelton, CT. This facility
is capable of producing approximately 4kg of the COVID-19 drug per batch. We anticipate that this scale would be sufficient for human
clinical trials, and possibly for initial introduction under Compassionate Use, EUA or similar regulatory approval.
Page 6 of 121
In the reported year and subsequently to date,
we have already completed pre-clinical IND-enabling studies on our novel SARS-CoV-2 drug candidate NV-CoV-2. In addition to NV-CoV-2 itself
as a drug to combat COVID-19, we are also developing another SARS-CoV-2 drug candidate, NV-CoV-2-R, which encapsulates remdesivir inside
NV-CoV-2. While remdesivir substantially blocks the replication of the virus inside cells, NV-CoV-2 is designed to block the virus outside
cells by entrapping it and thereby not allowing it to infect the cells in the first place. Thus NV-CoV-2-R is designed to block both the
intra-cellular life cycle of the virus and the extra-cellular life cycle of the virus. Blocking both lifecycles should enable complete
control of the viral disease, promising a potential cure. Remdesivir, sponsored by Gilead, is a known antiviral drug that has received
full US FDA approved for treatment of COVID-19 and has received EUA in many countries. We are developing NV-CoV-2-R on our own, independently
of Gilead.
We intend to develop NV-CoV-2 through Phase1/2a
clinical trials first. Most other drugs for COVID-19 have received EUA only. Dexamethasone, a well-known anti-inflammatory drug, has been
found to be very useful in the treatment of severe COVID-19 and is thought to act by suppressing the body’s own immune reaction
that is responsible for substantial portion of the lung damage seen in COVID-19, but has severe side effects at the dosages employed.
It is not expected to be reducing the viral load itself.
NV-CoV-2 and NV-CoV-2-R were found to be highly
effective against a totally lethal coronavirus lung infection in rats based on multiple indicators:
Survival: While rats
in the untreated infected group succumbed to the disease in 5 to 6 days, the rats in the NV-CoV-2 treatment group survived for 14 days,
and the rats in the NV-CoV-2-R treatment group survived for 16 days. In contrast, rats treated with remdesivir formulated in SBECD (comparable
to the FDA-approved Veklury® formulation of remdesivir) survived for only 7.5 days. The total dose of remdesivir was 90mg/kgBW for
the remdesivir treated group, and it was 80mg/kgBW when encapsulated in the NV-CoV-2-R group. Thus compared to treatment with remdesivir,
treatment with the Company’s drug candidate NV-CoV-2 extended the lifespan by approximately four times more days. Further, treatment
with the Company’s other drug candidate NV-CoV-2-R extended the lifespan by approximately five times more days.
Body Weight: Both NV-CoV-2
and NV-CoV-2-R protected the animals from body weight (BW) loss that results from the infection and immune response, in addition to the
substantially increased survival, in this lethal coronavirus infection model. NV-CoV-2 group lost only about 7% BW (12.5 g/animal) at
day 13, and the NV-CoV-2-R group lost as little as ~1.8% BW (3g/animal) at day 13. In contrast, the remdesivir group had already lost
~17% BW (30g/animal) by day 7 and succumbed to the disease soon thereafter.
These results clearly indicate strong effectiveness
of NV-CoV-2 as well as NV-CoV-2-R in fighting the coronavirus lung infection and its ill effects, as compared to the FDA-approved drug
remdesivir.
The (1) significant improvement in lifespan by
a factor of four to five, and (2) the significant prevention of body weight loss, upon treatment with NV-CoV-2 as well as NV-CoV-2-R as
compared to treatment with the FDA-approved remdesivir are important indicators for potential human clinical success of the Company’s
drug candidates.
The Company studied the effectiveness of these
drugs against the human coronaviruses h-CoV-NL63 (NL63) that uses the same ACE2 human cellular protein as receptor to gain entry into
cells as do all variants of SARS-CoV-2 and SARS-CoV-1. Additionally, the human pathology of NL63 infection closely mimics that of SARS-CoV-2,
albeit with limited disease severity. NL63 is a circulating human coronavirus that can be used in BSL2 labs. NL-63 is therefore being
used as a model for anti-SARS-CoV-2 drug development in various labs including ours (see Chakraborty and Diwan for a review: A. Chakraborty
and A. Diwan (2020). “NL63: A Better Surrogate Virus for studying SARS- CoV-2”. Integr Mol Med, 2020, vol.7, pp 1-9, doi:
10.15761/IMM.1000408).
Remdesivir (Veklury®, Gilead) has shown
relatively weak effectiveness in animal and clinical studies in contrast to its strong effectiveness in cell culture studies. This
has been related by scientists to the metabolism of remdesivir in the blood stream that causes loss of effectiveness. The Company
has developed the drug candidate NV-CoV-2-R by encapsulating (“hiding inside”) remdesivir into NV-CoV-2. The Company
believes that this encapsulation should protect remdesivir from bodily metabolism and thereby significantly increase its clinical
effectiveness (see below about pharmacokinetics of NV-CoV-2-R and protection of remdesivir).
Page 7 of 121
The strong effectiveness of NV-CoV-2 and NV-CoV-2-R
drug candidates in this animal model is consistent with whose previously reported effectiveness in cell culture studies against infection
of two human coronaviruses, hCoV-NL63, which was used in this animal efficacy study, and hCoV-229E, another circulating coronavirus that
uses a distinctly different receptor, namely APN. In contrast, while remdesivir was highly effective in the cell culture studies, it was
not very effective in this animal efficacy study, a result that is consistent with human clinical studies of remdesivir.
The effectiveness of NV-CoV-2-R observed in this
study can be understood as a combination of (a) the improvement in the effectiveness of remdesivir due to encapsulation, and (b) the effectiveness
of NV-CoV-2 by itself.
NV-CoV-2-R, we believe, is an excellent demonstration
of the power of the nanoviricides platform technology that enables combining multiple modalities seamlessly into a single drug.
We believe that these in vivo study results support
a potential synergistic improvement in the drug effect as a result of combining the two different mechanisms of attacking (i) the virus
reinfection cycle and (ii) the virus replication cycle simultaneously.
We have developed NV-CoV-2 and NV-CoV-2-R based
on its platform nanoviricides® 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. 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 cells. Antibodies in contrast attack a virus particle at only two attachment points per antibody.
It is anticipated that when a virus comes in contact
with the nanoviricide, not only would it land on the nanoviricide surface, binding to the copious number of ligands presented there, but
it would also get entrapped because the nanomicelle polymer would fuse with the virus lipid envelope, harnessing a well known biophysical
phenomenon called “lipid-lipid mixing”. In a sense, a nanoviricide drug acts against viruses like a “venus-fly-trap”
flower does against insects. Unlike antibodies that tag the virus and require the human immune system to take over and complete the task
of dismantling the virus, a nanoviricide is a nanomachine that is designed to not only bind to the virus but also complete the task of
rendering the virus particle ineffective.
In addition, the nanoviricide technology also
simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical
ingredients (APIs) within the core of the nanoviricide. The nanoviricide® technology is the only technology in the world, to the best
of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously
(b) disrupting intracellular production of the virus, thus blocking the complete lifecycle of the virus, enabling complete control of
a virus infection.
We have developed NV-CoV-2-R based on this
encapsulation capability that is built into its nanoviricide NV-CoV-2. The Company has chosen to encapsulate remdesivir as the
participating drug for blocking the viral replication cycle. Remdesivir is approved by the US FDA for the treatment of patients
hospitalized with COVID-19. Encapsulation of remdesivir in the Company’s nanoviricide envelope is believed to protect it from
metabolism in the body. This protection can be expected to lead to significant enhancement in the effectiveness of remdesivir itself
(in the encapsulated form), by potentially increasing both the effective remdesivir concentration and its duration of action. This
could be an additional favorable effect for the Company’s anti-coronavirus drug candidate NV-CoV-2-R. Remdesivir is sponsored
by Gilead. The Company is developing its drug candidates independently at present.
It should be noted that animals metabolize
remdesivir relatively rapidly, and this has been cited as a reason for poor efficacy of remdesivir in animal models. We further note
that the human clinical evidence of remdesivir efficacy against SARS-CoV-2 appears to reflect substantial metabolism in humans as
well, albeit perhaps not as strong as in rats, because the human clinical data to date did not reflect as strong an effectiveness of
remdesivir in blocking the viral infection as would be expected based on its cell culture studies. Thus, treatment with NV-CoV-2 and
with NV-CoV-2-R, at both dose levels employed, markedly extended survival of rats infected intra-tracheally (directly into the
lungs) with a lethal dose of human Cov-NL63 virus emulating the SARS-CoV-2 lung disease. Importantly, both treatments were also
markedly superior to Remdesivir treatment alone.
Page 8 of 121
Therefore, we believe that both NV-CoV-2 and NV-CoV-2-R
have shown strikingly superior effectiveness in animal models of the lung disease caused by the surrogate coronavirus, as compared to
the standard of care, remdesivir. The strong safety of NV-CoV-2 is expected to allow its use in circumstances where remdesivir may not
be recommended or may be contra-indicates, such as pregnancy or pediatric situations.
The non-GLP safety/toxicology studies in rats have been completed for
both NV-CoV-2 and NV-CoV-2-R. Rats dosed at up to 562 mg/kg body weight by tail vein intravenous injection on Days 0,1,3,5,7,and 9 for
a total of 3,375mg/kg dose of NV-CoV-2 showed no side effects. No evidence of any severe adverse reactions was observed during the administration
of the NV-CoV-2 or Vehicle during the study period and at postmortem examination in all dose groups of animals. All groups including the
NV-CoV-2 and Vehicle groups tolerated the compounds similarly. The body fluids and fecal analysis showed no significant difference between
the groups. Histopathological examination showed no changes either in the areas of small intestine or large intestine. No changes in organ
weight or histology were observed in all dose groups.
The GLP Safety/toxicology studies for NV-CoV-2 have been completed
with no evidence of adverse effects. In a GLP neuro-pulmonary safety pharmacology study in rats, the following conclusion was drawn: The
intravenous administration of NV-CoV-2 at doses of 25, 50 and 100 mg/kg did not affect respiratory function in rats.
In a GLP cardiovascular function study in the
NHP cynomolgus monkeys, the following conclusion was drawn: Intravenous infusion of NV-CoV-2 at 25, 37.5, and 50 mg/kg did not have any
toxicologic effects on cardiac rhythm or ECG morphology in cynomolgus monkeys in this study. No significant effects on blood pressure
and heart rate were observed after the intravenous infusion of NV-CoV-2.
The broad-spectrum anti-coronavirus effectiveness
of NV-CoV-2 and NV-CoV-2-R was established in cell culture studies. Both NV-CoV-2 and NV-CoV-2-R were found to be highly effective in
comparison to remdesivir against two distinctly different coronaviruses in our new cell culture studies. Remdesivir is one of the most
effective anti-coronavirus drugs in cell culture studies. Therefore our finding that NV-CoV-2 was highly effective and comparable to remdesivir
in activity in these cell culture studies was pleasantly surprising. Even more striking was the finding that NV-CoV-2-R exceeded the effectiveness
of remdesivir itself in these cell culture studies. These results indicate that NV-CoV-2 and NV-CoV-2-R could be some of the strongest
weapons in the fight against coronaviruses and the current COVID-19 global pandemic. These results are consistent with the effectiveness
of NV-CoV-2 and NV-CoV-2-R in animal studies against a coronavirus with lung pathology similar to the COVID-19 pathology.
Additionally, strong SARS-CoV-2 infection inhibition
activity of NV-CoV-2 was observed in a standard pseudovirion study. Pseudovirion assay is a standard method for evaluating virus entry-inhibitors
in BSL2 laboratories and is primarily used for viruses that require high security BSL3 or BSL4 laboratories otherwise. In this study,
SARS-CoV-2- pseudovirions virus particles that carry a green fluorescent protein (GFP) producer mRNA inside, and use the SARS-CoV-2 S1
protein on their surface to bind to ACE2 receptor protein on cells were made. They were incubated with NV-CoV-2, or a known neutralizing
antibody (positive control), or just the vehicle buffer (negative control). Then these solutions were separately used to infect ACE2 positive
cells and the virus allowed to grow. The virus infectivity was determined by measuring the number of GFP positive cells (i.e. infected
cells) versus the uninfected cells. In this well-known assay, NV-CoV-2 was as effective as the neutralizing antibody in reducing the virus
infection. This study demonstrates that NV-CoV-2 attacks the SARS-CoV-2 virus particles and renders it incapable of binding to the ACE2
positive cells.
NV-CoV-2-R
NV-CoV-2-R was observed to provide significant
advantages to its encapsulated component remdesivir in terms of substantially superior pharmacokinetics consistent with our expectation
in designing this drug by encapsulating remdesivir within our lead drug candidate NV-CoV-2. This encapsulation results in the dual-acting
drug candidate NV-CoV-2-R which we believe has the promise of a potential pan-coronavirus cure.
Page 9 of 121
Pharmacokinetics of Encapsulated Remdesivir
Compared to Standard Formulation
Almost double the amount of remdesivir remained
intact in plasma when given as the encapsulated NV-CoV-2-R form, in comparison to the standard remdesivir formulation made in betadex
sulfobutyl ether sodium (SBECD), during the first day of dosing in a rat pharmacokinetics study in the time profile. Additionally, remdesivir
accumulation was observed on repeated dosing of NV-CoV-2-R. After the fifth dose of NV-CoV-2-R (on day 7), in comparison to the standard
remdesivir dosing pattern (twice on day 1 followed by daily thereafter; on day 7), the circulating level of intact remdesivir in plasma
was 75% greater in the NV-Cov-2-R group as compared to the standard remdesivir group. The data were normalized to reflect the same amount
of remdesivir given to the animals per kg body weight for uniform comparison. The assays were performed using the well-established isotopic
internal standard method of remdesivir estimation with LCMS detection.
The increased circulating level of intact remdesivir
when given as NV-CoV-2-R encapsulated formulation without any increase in toxicity is significant. It can be expected to result in improved
antiviral effectiveness of the remdesivir component in human usage of NV-CoV-2-R treatment. This is important because remdesivir is a
highly effective drug in cell culture and pre-clinical studies but does not show clinical effectiveness in humans at levels that would
be expected based on its cell culture efficacy because of its rapid metabolism. Additionally, there is very little margin to increase
remdesivir dosing in its standard formulation because of dose limiting toxicity.
Importantly, NV-CoV-2-R was found to be less toxic
than the standard remdesivir formulation in this study. At day 7, when a total of 80mg/kg remdesivir was dosed in the standard formulation,
the body weight loss was approximately 9.5% in male and 9.5% in female animals. In contrast, when 80mg/kg of remdesivir was delivered
as NV-CoV-2-R encapsulated formulation, at day 7, the weight loss was only approximately 3% in male animals and 1% in female animals that
was the same as with the vehicle treatment reflecting injection trauma itself and no drug toxicity.
These data demonstrate that the pan-coronavirus
nanoviricide drug candidate NV-CoV-2-R substantially decreases the loss of remdesivir to bodily metabolism in comparison to the standard
formulation, and also minimizes toxic effects of remdesivir. We anticipate that this stabilizing effect should lead to a highly effective
pan-coronavirus drug that could potentially cure most cases of COVID-19 infection.
Both remdesivir and NV-CoV-2 have demonstrated
broad-spectrum activity against coronaviruses. Thus NV-CoV-2-R is expected to continue to be active in spite of evolution of novel variants
of SARS-CoV-2. In contrast, antibody drugs and vaccines which induce antibodies lose effectiveness against variants. The more the variant
drifts from the original strain, the less protection is offered by vaccines, and effectiveness of antibodies also diminishes significantly.
This is now known to be occurring for current vaccines and antibodies during the global COVID-19 pandemic.
NV-CoV-2-R combines (1) the power of the nanoviricides®
platform attacking the virus particle outside cells with (2) the power of remdesivir in attacking the virus reproduction inside cells.
Additionally, we believe that (3) NV-CoV-2-R would be improving the effect of remdesivir by (a) enabling a higher effective concentration
of remdesivir in the body and (b) sustaining this higher concentration for a substantially longer period of time, both compared to the
standard formulation of remdesivir, as observed in this pharmacokinetic animal study.
NV-CoV-2-R combines two different mechanisms of
attack against the virus and therefore is expected to be substantially more difficult for the virus to evade than either NV-CoV-2 or remdesivir
alone. This is important because scientists believe it is only a matter of time before variants of SARS-CoV-2 that evade current vaccines
and antibody drugs become commonplace.
Both NV-CoV-2 and remdesivir are expected to retain
their effectiveness against existing and emerging variants of SARS-CoV-2. NV-CoV-2 has shown effectiveness against multiple unrelated
coronavirus types. Remdesivir has been demonstrated to possess antiviral activity in cell culture against a large number of RNA viruses.
The standard Veklury® formulation of
remdesivir in betadex sulfobutyl ether sodium (SBECD) helps with suspending remdesivir in solution, but does not appear to
significantly improve upon the metabolic effects. In contrast, NV-CoV-2-R is an encapsulation approach wherein remdesivir would
slowly leak out into the bloodstream from the polymeric nano-micelle over time, imparting protection against metabolism and
sustained effective levels of the encapsulated drug component over a longer time period.
Page 10 of 121
The strong effectiveness of our drug candidates
NV-CoV-2 and NV-CoV-2-R against two unrelated coronaviruses, namely hCoV-NL63 and hCoV-229E, and SARS-CoV-2 pseudovirions in cell culture
studies indicates their strong potential for treatment of coronavirus diseases including COVID-19, irrespective of variants or coronavirus
types. The broad-spectrum effectiveness of the Company’s drug candidates is very important as coronavirus variants that are reported
to evade antibodies, potentially causing disease in spite of vaccination, are becoming widespread as the COVID-19 global pandemic is progressing
into its second year.
We believe that our broad-spectrum anti-coronavirus
drugs will continue to be effective even as the virus continues to mutate developing into a number of variants of concern. Antibody protection
afforded by vaccines and the effectiveness of antibody drugs have continued to decline progressively as new SRAS-CoV-2 variants continue
to emerge. We believe that our unique anti-viral nanomachine technology overcomes these issues.
Oral administrations of NV-CoV-2 as well as NV-CoV-2-R were also found
to be highly effective in a lethal coronavirus lung infection rat model. The oral delivery requires more dosing for equivalent effect
compared to injectable delivery, as is normal for all drugs except a few that directly work in gastroenteric path itself. Additionally,
the extremely strong safety of our drugs, particularly NV-CoV-2, is expected to be very important for pediatric application.
Thus we believe that we will be able to develop
oral formulations suitable for use in pediatric patients, and we plan to include pediatric cohorts into clinical trials at the appropriate
stages. As the variants evolve, pediatric infections and their severity have begun to rise, causing major worldwide concerns even as the
world is trying to move towards normalcy in education and child social interactions.
Corporate Events - Intellectual Property
Our drug development business model was formed
in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc.(TheraCour) that enabled creation of
drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our
intellectual property. We have a worldwide exclusive license to this technology for several drugs with specific targeting mechanisms for
the treatment of a number of human viral diseases including coronaviruses, herpesviruses, VZV, HIV, Influenza, and others.
On June 9, 2020, we reported in a press release
that the Company signed a Memorandum of Understanding (“CovMoU”) with respect to anti-viral treatments for coronavirus derived
human infections (the “Field”) with TheraCour. The MoU specifically provides a limited, exclusive license to all research
and development in the Field for further research and development purposes towards human clinical trials. Dr. Diwan recused himself
in the Board’s discussions on the MoU, and recuses himself from the Company’s discussions regarding the license agreements
as well. Our Board of Directors retained an independent consultant for the evaluation of the assets in order to develop the full license
agreement. We intend to perform the regulatory filings and own all the regulatory licenses for the drugs we are currently developing.
We will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials.
On September 14, 2021, we announced execution
of a license agreement for the field comprising anti-viral treatments for coronavirus derived human infections with TheraCour on September
9, 2021 (the “CoV Agreement”). The licensed field includes antiviral drugs to treat SARS-CoV-2 and its variants that cause
the COVID-19 disease resulting in a global pandemic that continues to rage through the world, wave after wave, as new variants develop
and take hold. There was no upfront cash payment for the license and the compensation terms were generally consistent with prior licenses,
and are summarized below.
Page 11 of 121
Under the CoV Agreement, we have obtained a world-wide,
exclusive, sub-licensable, license to use, promote, offer for sale, import, export, sell and distribute antiviral drugs that treat human
Coronavirus infections using TheraCour’s proprietary as well as patented technology and intellectual property, including the new
patent application cited above. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization,
as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between
the parties, with no duplication of costs allowed. We will not make any upfront cash payments to TheraCour and we have agreed to the following
milestone payments to TheraCour: 100,000 shares of the Company’s Series A Convertible Preferred Stock, par value $0.001 per share
(the “Series A Preferred Stock”) upon the execution of the Agreement; 50,000 shares of Series A Preferred Stock after the
grant of the approval of Licensee’s Investigational New Drug (IND) Application, or its equivalent; cash payments of $1,500,000 after
the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion of Phase 1 Clinical Trials or its equivalent
for at least one product within twelve (12) months from the date of the acceptance of the IND; $2,500,000 no later than six (6) months
after the completion of Phase 2A Clinical Trials or its equivalent for at least one product within twenty (24) months from the date of
the completion of Phase 1 or its equivalent; 100,000 shares of Series A Preferred Stock after the initiation of Phase 3 clinical trials
or its equivalent; and, at TheraCour’s option, $5,000,000 in cash or 500,000 shares of Series A Preferred Stock, no later than six
(6) months after the completion of Phase 3 Clinical Trials or its equivalent for at least one product within thirty-six (36) months from
the completion of Phase 2 Clinical Trials or its equivalent. In addition, we agreed to pay to TheraCour fifteen percent (15%) of net sales
of licensed products and any income from sublicensed products, consistent with previous agreements. Under the CoV Agreement, TheraCour
retains the exclusive right to develop and manufacture the Licensed Products. The Agreement contemplates that the parties will enter into
a separate Manufacturing and Supply Agreement for the commercial manufacture and supply of the drug products if and when we intend to
engage into commercialization of the drugs. The CoV Agreement provides that the Manufacturing and Supply agreement would be on customary
and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup
manufacturing rights, as with prior agreements. The Series A Convertible Preferred Shares are only convertible upon a “change of
control” of the Company as defined in its full specification, are non-transferrable and have no trading market. Each Series A share
carries 9 votes, and is convertible only upon a change of control into 3.5 shares of the Company’s common stock.
To assist in the analysis of the terms of the CoV Agreement, we commissioned
research reports on Coronavirus drug market sizes for the Coronavirus antiviral field from an independent consulting agency, Nanotech
Plus, LLC. Additionally, we obtained business analysis and valuation reports for potential licensing terms for a coronavirus drug from
an independent consultant. NanoViricides was represented by McCarter & English, LLP while TheraCour was represented by DuaneMorris
LLP.
A new patent application regarding coronavirus
drug candidates has been filed under the Patent Cooperation Treaty (PCT) on June 25, 2021, and is automatically licensed by us under the
CoV Agreement. Our anti-COVID drugs are based on polymeric micelle nanomedicine technologies developed by TheraCour and its affiliate,
AllExcel, Inc.(“Allexcel”). The inventors at AllExcel have filed a broad PCT patent application that forms the basis of our
two lead drug candidates, namely, NV-CoV-2 and NV-CoV-2-R. The new patent application covers the new technologies, compositions, formulations,
processes, manufactured products, and methods of use, among other specifics. This patent application was filed on June 25, 2021, application
number PCT/US2007/001607, entitled “Self-Assembling Amphiphilic Polymers As Anti-Covid-19 Agents”. Its nominal expiry date
would be 20 years, after filing and if issued, i.e. June 24, 2041, and could be extended in certain countries under regulatory extensions
to as late as into the year 2043, providing a significant commercial runway.
We believe that we currently do not need a
license for the use of remdesivir in developing the novel nanoviricide drug candidates that encapsulate remdesivir. We have
undertaken encapsulation of remdesivir into certain of its drug candidates for the treatment of coronavirus because we believe that
this encapsulation would result in substantial patient benefits. However, we believe that our anti-coronavirus drug candidates have
shown significant anti-coronavirus activity in cell culture and animal studies, and therefore are expected to be viable drugs
against human coronavirus infections by themselves, without encapsulating remdesivir. At present, we believe that to develop our
drug candidate NV-CoV-2 as independent, we may need to also use the approved remdesivir treatment as standard of care in addition to
the new nanoviricide drug candidate in the human clinical trial treatment arm. It may be possible that encapsulation would improve
the pharmacokinetics of remdesivir and thereby improve its effectiveness when in encapsulated form. These possibilities can only be
evaluated in a human clinical trial. We believe that any license for the use of remdesivir encapsulation in our novel drugs, if
necessary, will be feasible in the interests of resolving the pandemic. We would also be willing to collaborate with Gilead
Sciences, Inc., the developer of remdesivir, for developing the encapsulated drug. There is currently no collaboration agreement
with Gilead Sciences, Inc., nor any assurance that such an agreement can be reached. The Company is currently developing its
anti-coronavirus clinical drug candidates NV-CoV-2 and NV-CoV-2-R independently.
Page 12 of 121
Corporate Events - Financing
We had approximately $20.5 million cash in hand
as of June 30, 2021, the end of the reporting period. We spent approximately $8.2 million in cash on operating activities in the reported
year, although our expenditure is expected to increase upon commissioning of human clinical trials. We believe we have sufficient financing
to complete at least the initial set of human clinical trials for our most advanced drug candidate, namely, NV-CoV-2.
On July 8, 2020, we entered into an underwriting
agreement (the “Underwriting Agreement” or “Offering”) with Kingswood Capital Markets, a Division of Benchmark
Investments, Inc. (“Kingswood”, now EF Hutton Group). The Offering was consummated on July 10, 2020, whereby we sold 1,369,863
shares of Common Stock and a fully exercised Underwriters’ over-allotment option of 205,479 additional shares the public offering
price of $7.30 per share. No warrants were issued in this Offering. The net proceeds to us from the Offering was approximately $10.4 million
after deducting underwriting discounts and commissions and other estimated offering expenses payable by us.
On July 31, 2020, we entered into an At Market
Issuance Sales Agreement (the “Sales Agreement”) with B. Riley Securities, Inc. and Kingswood Capital Markets, a division
of Benchmark Investments, Inc. (each a “Sales Agent” and collectively, the “Sales Agents”), pursuant to which
we may offer and sell, from time to time, through or to the Sales Agents, shares of Common Stock (the “Placement Shares”),
having an aggregate offering price of up to $50 million (the “ATM Offering”). Sales pursuant to the Sales Agreement will be
made only upon instructions by us to the Sales Agents, and we cannot provide any assurances that it will issue any Shares pursuant to
the Sales Agreement. Actual sales will depend on a variety of factors to be determined by us from time to time, including (among others)
market conditions, the trading price of our Common Stock, capital needs and determinations by us of the appropriate sources of funding.
We are not obligated to make any sales of Common Stock under the Sales Agreement and we cannot provide any assurances that it will issue
any shares pursuant to the Sales Agreement. We will pay a commission rate of up to 3.5% of the gross sales price per share sold and agreed
to reimburse the Sales Agents for certain specified expenses, including the fees and disbursements of its legal counsel in an amount not
to exceed $50,000 and have agreed to reimburse the Sales Agents an amount not to exceed $2,500 per quarter during the term of the Sales
Agreement for legal fees to be incurred by the Sales Agents. We have also agreed pursuant to the Sales Agreement to provide each Sales
Agent with customary indemnification and contribution rights.
On March 2, 2021 we sold 814,242 shares of common
stock at an average price of $7.83 under the “At-the-Market Issuance” Sales Agreement with B. Riley Securities, Inc. The net
proceeds from the offering were approximately $6.1 million after deducting underwriting discounts and commissions and other offering expenses.
Management believes that the Company has several
important milestones to be achieved in the ensuing year. Management believes that as it achieves these milestones, the Company’s
ability to raise additional funds in the public markets would be enhanced and support our goals of obtaining approvals for our COVID-19
drug candidates, marketing, establishing additional commercial scale manufacturing, and re-engaging additional drug development programs
that are currently on hold.
Page 13 of 121
Corporate Events - Board
On November 19, 2020, we announced that Mr.
Brian Zucker, CPA, has joined the Company’s Board of Directors, effective November 13, 2020, as an independent director. He
was also appointed as a member of the Board’s Audit Committee, Nomination Committee and Compensation Committee. Mr. Zucker is
a Partner at CFO Financial Partners, LLC (https://www.cfopartners.com/), a firm that provides outsourced CFO (Chief Financial
Officer), Controller and Financial Operations services as well as back office reporting and bookkeeping services for public and
private companies, broker dealers, hedge funds, and family offices and high net worth individuals, among others. Mr. Zucker also
serves as the CFO and Financial Operations Principal for numerous broker dealers and hedge funds. In addition to and simultaneously
therewith, Mr. Zucker has served as a Partner at RRBB Accountants & Advisors, (aka Rosenberg Rich Baker Berman & Co.), a
full-service accounting, advisory and consulting firm located in Central New Jersey. He has over thirty years of experience as a CPA
specializing in the securities industry.. From 1983 through 1986, Mr. Zucker was a Senior Consultant at Deloitte Haskins and Sells
and at Price Waterhouse from January 1987 through September 1989. He has previously served as the President and Chairman of Atlantis
Business Development Corp. (ABDV), CFO of Natcore Solar Technology, Inc. (NTCXF) and as a Managing Director of American Frontier
Financial Corp. (EVIS). Since May 2018, he has been serving as the CFO of EIG Energy Partners Capital Markets, LLC. Brian holds a
CPA in States of New Jersey and New York, and holds several FINRA licenses. He is on the Board of Directors of National Investment
Banking Association (NIBA). Mr. Zucker obtained a B.S. in Public Accounting from Pace university. We believe we have thus
strengthened our Audit Committee and our Board of Directors with the addition of Mr. Brian Zucker who brings valuable multi-faceted
experience with public companies, as well as financings and banking institutions to our Board.
Page 14 of 121
The Nanoviricide Platform Technology in Brief
The Company develops its class of drugs, that
we call nanoviricides®, using a platform technology. This approach enables rapid development of new drugs against a number of different