SHELTON, CT / ACCESSWIRE, Feb 24, 2020 - (ACN Newswire) -
NanoViricides, Inc. (NYSE American: NNVC), a global leader in the
development of highly effective antiviral therapies based on a
novel nanomedicines platform, has filed its quarterly report for
its second quarter of financial year 2020 in a timely manner with
the Securities and Exchange Commission. This press release should
be read in conjunction with the Form 10-Q filed on February 14,
2020. The submission can be downloaded from the SEC website at:
https://www.sec.gov/Archives/edgar/data/1379006/000110465920021930/tm205411-1_10q.htm.
The Company reported that it had approximately $1.0 Million (M) of
current assets (cash, cash equivalents, and prepaid expenses), and
current cash liabilities of approximately $1.4M excluding a recent
mortgage (described below), as of December 31, 2019, the end of the
reporting period. The net cash used in operating activities during
the six months period was approximately $2.56M. The Company's
expenditures were in line with budget estimates. Shareholder equity
stood at approximately $7.72M for the quarter (unaudited figures),
primarily due to the asset value of its cGMP-capable manufacturing
facility, R&D labs, and equipment, that it owns fully except
for a $2 Million secured debt provision. The Company had no
revenues. The Company has no long term debt.
The Company drew down $1.1M from a $2M non-convertible loan
commitment secured by a mortgage on the Company's facility provided
by the Company's founder and President, Anil R. Diwan, PhD. The
mortgage is payable in full on March 31, 2021, with no payments due
until then. Interest is payable only on amounts drawn by the
Company.
In subsequent events, the Company has previously reported that it
has raised approximately $8.625M in gross proceeds in an
underwritten public offering, pursuant to an effective Form S-1
registration statement, comprising the sale of 2.5 million shares
plus 375,000 shares of an underwriters over-allotment option at a
price of $3 per share, with no warrants issued in the transaction.
Aegis Capital Corp. acted as sole bookrunner for the offering. The
net proceeds to the Company after underwriter's commission and
agreed upon customary fees and expenses were approximately $7.78
million, before deducting the Company's legal and accounting
expenses related to the Offering.
With these cash inflows, the Company believes it has sufficient
funding for its planned expenditures for the ensuing year, based on
estimated budgets including costs of certain clinical trials.
In subsequent events, the Company previously reported that it is
working on developing a therapeutic drug for the treatment of the
novel coronavirus 2019-nCoV, aka COVID-19. In 2014, the Company had
engaged in drug discovery efforts against MERS coronavirus. The
Company has reported that it has already found broad-spectrum
virus-binding ligands that are expected to attack the virus at the
same points that the virus uses to bind to its cognate cellular
receptor, namely ACE-2 (angiotensin converting enzyme type 2),
using molecular modeling based on known SARS-CoV and ACE2
interactions. COVID-19 shares significant similarity with, and uses
the same cellular receptor as, SARS-CoV. The Company intends to
perform initial testing of these drug candidates for safety and
effectiveness in cell culture studies in its own BSL-2 virology
laboratory at its Shelton campus, using low-threat coronavirus
strains that have been normally circulating in human
population.
The Company is working on developing necessary collaborations to
take the program further should an effective drug candidate be
identified. However, there can be no assurance that the Company
will be successful in entering into such collaborations or that
such collaborations will lead to an effective drug candidate. The
Company does not currently have a license for the coronavirus field
from TheraCour Pharma, Inc. ("TheraCour"), the licensor of the
Company's pharmaceutical candidates and a significant shareholder.
Customarily, the Company enters into licensing agreements with
TheraCour after a potential drug candidate is demonstrated to be
likely effective against the virus. TheraCour has not previously
denied any licenses sought by the Company.
The Company has experience developing broad-spectrum cellular
receptor mimetics as virus-binding ligands for creating
nanoviricide drugs. The Company has demonstrated this capability
notably in its HerpeCide(TM) program, wherein nanoviricides based
on the same antiviral ligand were found to be effective against at
least three different kinds of herpesviruses, namely herpes
simplex-1 (HSV-1), herpes simplex-2 (HSV-2), and, surprisingly, the
non-simplex varicella zoster virus (VZV).
It is well recognized that development of vaccines takes a long
time, and that vaccines can often be ineffective against viruses
due to viral mutations that lead to emergence of resistant strains.
It is also well recognized and well documented that monoclonal
antibodies as antiviral drugs are very difficult to develop and
often lead to emergence of resistant viral strains due to viral
mutations.
In contrast, the Company believes that, its nanoviricide biomimetic
technology platform has the potential to develop broad-spectrum
antiviral drugs that viruses may not be able to escape due to
mutations.
The Company continues to advance its first drug candidate, namely
NV-HHV-101 skin cream, for the treatment of shingles rash as its
first indication, towards human clinical trials. All of the planned
IND-enabling Safety/Toxicology studies as well as other required
non-clinical studies have been completed, and draft reports of
various studies are being circulated between collaborating parties,
as of the filing date. The Company anticipates receiving final cGLP
reports for inclusion in our IND filing once the quality assurance
processes are completed.
The Company has undertaken cGMP manufacture of the drug product,
namely, NV-HHV-101 skin cream, indicated for the topical treatment
of shingles rash, for supplying anticipated Phase I human clinical
trials at its own facility. The Company has industry-leading
internal expertise in the cGMP manufacture of complex nanomedicines
drugs, right from simple starting materials to formulated drug
products.
In a human skin patch organ culture model ex vivo, the Company has
previously demonstrated the effectiveness and safety of topical
NV-HHV-101 against VZV, the cause of shingles and chickenpox. These
studies were conducted by Professor Jennifer Moffat at the Upstate
Medical Center, SUNY Syracuse, NY. Professor Moffat has developed
this model for pre-clinical evaluation of therapeutics against VZV,
and is a well known expert in the field.
It is anticipated that the high effectiveness of our clinical drug
candidate observed in this human skin model should be predictive of
effectiveness in human clinical trials for topical dermal treatment
of shingles.
Following shingles drug development, the Company anticipates
developing drugs for HSV-1 cold sores and HSV-2 genital ulcers
treatments using NV-HHV-101. The total market for our HerpeCide(TM)
program drugs is estimated at several tens of billions of dollars
because neither cures nor very effective treatments are available.
The Company also has drug candidates in development at different
pre-clinical stages in its Influenza and HIV drug programs. In
addition, the Company has drug candidates against Dengue viruses,
and was developing drugs against Ebola/Marburg viruses among
others. The Company anticipates re-engaging these programs upon
appropriate financing becoming available. Thus the Company has a
rich and expanding pipeline of highly effective and safe drug
candidates against a number of viral diseases.
NanoViricides is pioneering a unique platform for developing
anti-viral drugs based on the "bind-encapsulate-destroy"
principles. Viruses would not be able to escape a properly designed
nanoviricide(R) drug by mutations because in doing so they would
lose the ability to bind their cognate cellular receptor(s) and
thus fail to infect productively, becoming incompetent.
There is a significant unmet medical need for the topical treatment
of shingles rash. An effective therapy for shingles has been
estimated to have a market size into several billions of dollars,
if it reduces PHN incidence. An effective therapy for shingles rash
reduction alone is estimated to have a market size of several
hundred million dollars to low billion dollars. These market size
estimates have taken into account the potential impact of the new
Shingrix(R) GSK vaccine, assuming scaling up of their production in
the 2024 time-frame, and the impact of the existing Zostavax(R)
vaccine. Of note, the Shingrix vaccine has been found to cause
significant, debilitating, side effects in as many as 15%-20% of
the persons receiving it. Given that shingles is not a
life-threatening disease (except under certain conditions), the
uptake of such a vaccine with high incidence of adverse effects may
be limited. Shingrix is not yet widely available.
The Company develops its class of drugs, that we call
nanoviricides(R), 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. The
nanoviricide(R) 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 a maximum of
two attachment points per antibody. 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.
About NanoViricides
NanoViricides, Inc. (www.nanoviricides.com) is a development stage
company that is creating special purpose nanomaterials for
antiviral therapy. The Company's novel nanoviricide(R) 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. 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.
The Company's technology is based on broad, exclusive,
sub-licensable, field licenses to drugs developed in these areas
from TheraCour Pharma, Inc.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
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. CMC refers to
"Chemistry, Manufacture, and Controls".
SOURCE: NanoViricides, Inc.
Source: NanoViricides, Inc.
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