NanoViricides
Has Filed Quarterly Report for Period Ending
December 31,
2020 -
Has Sufficient Cash, Coronavirus
Drug Candidate
Safe in GLP Safety Toxicology Moving
Towards
IND
SHELTON,
CONNECTICUT – February
17, 2021
--
InvestorsHub NewsWire -- NanoViricides,
Inc. (NYSE American: NNVC)
(the "Company") a global leader in the development of highly
effective antiviral therapies based on a novel nanomedicines
platform
(the "Company"), has filed its quarterly report for its
second
quarter
of financial year 2021 with the Securities
and Exchange Commission. This press release
should be read in conjunction with the Company's
Form 10-Q
filed on February
16, 2021.
The submission can be downloaded from the SEC website
at:
https://www.sec.gov/Archives/edgar/data/1379006/000110465921024154/tm214592d1_10q.htm.
The Company reported
that it had approximately $18.39 million of current
assets (cash, cash equivalents, and prepaid expenses), and current
cash liabilities of approximately $0.34 million,
after repayment of the
short
term
mortgage loan of $1.1
million
secured
by the Company's
facility
that the Company
had
obtained in December 2019 from Dr. Anil Diwan, founder and
President of the
Company, on
December
31, 2020. As of
December 31, 2020 the
Company has no
debt, and the
Stockholder's equity
was approximately
$27.74
million.
During
the six-month period ended December 31, 2020 approximately
$4.55M in cash
was
used toward operating
activities. The Company had no
revenues. (All figures are
unaudited).
The Company believes
it has sufficient funds for initial human clinical trials of at
least one of its drug candidates.
The Company has been
developing pan-coronavirus broad-spectrum antiviral drug candidates
for the treatment of infected persons with COVID-19 since the first
news of the novel 2019-nCoV disease
came
out. The Company
is
successfully
advancing
broad-spectrum
nanoviricide
anti-coronavirus
drug
candidates towards human clinical trials.
The Company's drug
candidate NV-CoV-2 is a
nanoviricide®
that is
designed to attack coronaviruses irrespective of the
variant. This is important
because variants that are less sensitive to vaccines and antibodies
than the original strain are already in widespread circulation in
various countries. In fact the South African variant lineage B1.351
has already been found in Connecticut in a patient with no known
travel history.
The Company recently
reported in a press release that NV-CoV-2 had successfully
completed GLP
core
safety pharmacology studies that are
required
prior to filing an IND and was found to be
safe and well
tolerated.
In addition, the
Company has developed NV-CoV-2-R, which is a drug candidate that
encapsulates (holds in its "belly")
remdesivir
inside
the NV-CoV-2 nanomicelles.
NV-CoV-2-R is thus designed to attack both (1) the virus lifecycle
outside the cells, and (2) the virus lifecycle inside
the
cells, enabling complete
control of the infection. Therefore
NV-CoV-2-R
is
expected to be a potential
cure for
the virus.
The Company is
preparing to submit a pre-IND application to the US FDA with safety
tolerability and effectiveness data to obtain guidance regarding
human clinical trials. Additionally, the Company is
actively
seeking opportunities to engage appropriate sites for human
clinical trials. Further, the Company is
engaged
in the preparation of clinical trial protocols and other activities
that would be necessary for submitting an IND application to the US
FDA.
The need for the
broad-spectrum, pan-coronavirus nanoviricide
drug
treatments cannot be overstated
for combating the COVID-19 pandemic given the current circumstances
and the present status of the pandemic. New virus variants continue
to develop in the field. The variants that have advantages in terms
of transmissibility, infectivity, and escape from drugs and
vaccines will continue to evolve and spread, replacing prior
variants, especially under
pressure of the use of vaccines and antibodies. The
phenomenon
that
viruses develop variants to escape vaccines and antibodies
is well
known.
Of concern is the
fact that a mutation that is thought to enable the virus to escape
a number of current vaccines, E484K, already present in
the South African variant B1.351, and the Brazilian variant
P.1, has spontaneously
and independently
arisen
sporadically
within the B1.1.7 UK-Kent
variant. At present, B.1.1.7 is spreading in the USA, and is
projected to become
the
dominant variant soon. B1.351 has also been
found in the USA.
The available
monoclonal antibody drugs and convalescent plasma antibodies have
been reported to be less effective against several
variants compared to the
original target strain.
By the very nature of
how they work, vaccines and antibodies tend to be highly specific
to the target virus variant, and do not afford strong protection
against differentiated variants that are
evolutionarily
distant
from the target variant. This scientific fact is now well
demonstrated for the COVID-19 pandemic.
It is
thus
evident that effective
broad-spectrum anti-coronavirus drugs such as the Company's
NV-CoV-2 and NV-CoV-2-R will be needed before
the world can return to normal activity.
The Company has
developed NV-CoV-2 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 turn around and 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, thereby enabling complete
control of a virus infection.
The Company has
developed NV-CoV-2-R based on this encapsulation capability that is
built in 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 SARS-CoV-2
infection. Encapsulation
of remdesivir
in
the
Company's nanoviricide
envelope
is expected 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.
About
NanoViricides
NanoViricides,
Inc. (the "Company")(www.nanoviricides.com)
is a development stage company that is creating special
purpose nanomaterials
for
antiviral therapy. The Company's novel nanoviricide®
class of drug candidates are designed to specifically attack
enveloped virus particles and to dismantle them. Our lead drug
candidate is NV-HHV-101 with its first indication as dermal topical
cream for the treatment of shingles rash. In addition, we are
developing a clinical candidate for the treatment of COVID-19
disease caused by SARS-CoV-2 coronavirus. The Company cannot
project an exact date for filing an IND for this drug because of
its dependence on a number of external collaborators and
consultants.
The Company is now
working on tasks for completing an IND application. The Company is
currently pursuing two separate drug candidates for the treatment
of COVID-19 patients. NV-CoV-2 is our nanoviricide
drug
candidate that does not encapsulate remdesivir.
NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2
with remdesivir
encapsulated in it.
The Company believes that since remdesivir
is
already US FDA approved, our drug candidate encapsulating
remdesivir
is likely
to be an approvable drug, if safety is comparable.
Remdesivir
is
developed by Gilead. The Company has developed both of
its
own drug
candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company intends
to re-engage into an IND application to the US FDA for NV-HHV-101
drug candidate for the treatment of shingles once its COVID-19
project moves into clinical trials, based on resources
availability. The NV-HHV-101 program was slowed down because of the
effects of recent COVID-19 restrictions, and re-prioritization for
COVID-19 drug development work.
The Company is also
developing drugs against a number of viral diseases including oral
and genital Herpes, viral diseases of the eye including EKC and
herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal
Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus,
among others. NanoViricides'
platform technology and programs are based on the
TheraCour®
nanomedicine
technology of
TheraCour,
which TheraCour
licenses
from AllExcel. NanoViricides
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-1 and
HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu
Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus
and Ebola/Marburg viruses. The Company has executed a Memorandum of
Understanding with TheraCour
that
provides a limited license for research and development for drugs
against human coronaviruses. The Company intends to obtain a full
license and has begun the process for the same. The Company's
technology is based on broad, exclusive, sub-licensable, field
licenses to drugs developed in these areas from TheraCour
Pharma,
Inc. The Company's business model is based on licensing
technology from TheraCour
Pharma
Inc. for
specific application verticals of specific viruses, as established
at its foundation in 2005.
As is customary, the
Company must state the risk factor that the path to typical drug
development of any pharmaceutical product is extremely lengthy and
requires substantial capital. As with any drug development
efforts by any company, there can be no assurance at this time that
any of the Company's pharmaceutical candidates would show
sufficient effectiveness and safety for human clinical
development. Further, there can be no assurance at this time
that successful results against coronavirus in our lab will lead to
successful clinical trials or a successful pharmaceutical
product.
This press release
contains forward-looking statements that reflect the Company's
current expectation regarding future events. Actual events could
differ materially and substantially from those projected herein and
depend on a number of factors. Certain statements in this release,
and other written or oral statements made by NanoViricides,
Inc. are "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. You should not place undue reliance on
forward-looking statements since they involve known and unknown
risks, uncertainties and other factors which
are, in
some cases, beyond the Company's control and which could, and
likely will, materially affect actual results, levels of activity,
performance or achievements. The Company assumes no obligation to
publicly update or revise these forward-looking statements for any
reason, or to update the reasons actual results could differ
materially from those anticipated in these forward-looking
statements, even if new information becomes available in the
future. Important factors that could cause actual results to differ
materially from the company's expectations include, but are not
limited to, those factors that are disclosed under the heading
"Risk Factors" and elsewhere in documents filed by the company from
time to time with the United States Securities and Exchange
Commission and other regulatory authorities.
Although
it is not possible to predict or identify all such factors, they
may include the following: demonstration and proof of principle in
preclinical trials that a nanoviricide
is safe
and effective; successful development of our product candidates;
our ability to seek and obtain regulatory approvals, including with
respect to the indications we are seeking; the successful
commercialization of our product candidates; and market acceptance
of our products.
FDA refers to US Food
and Drug Administration. IND application refers to "Investigational
New Drug" application. cGMP
refers to
current Good Manufacturing Practices. CMC refers to "Chemistry,
Manufacture, and Controls". CHMP refers to the Committee for
Medicinal Products for Human Use, which is the European Medicines
Agency's (EMA) committee responsible for human
medicines.
Contact:
NanoViricides,
Inc.
info@nanoviricides.com
Public
Relations Contact:
MJ
Clyburn
TraDigital
IR
clyburn@tradigitalir.com
Source:
NanoViricides,
Inc.