SHELTON, CT / ACCESSWIRE – (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.