NanoViricides, Inc. (NYSE MKT: NNVC) (the “Company”), announced
today that the annual meeting of its shareholders was held on
December 9th in Stamford, CT. The meeting was well attended in
spite of poor weather conditions. All of the Directors of the
Company were present. Professor Mukund Kulkarni and Mr. Stanley
Glick were present in person. Dr. Milton Boniuk had sent Ms. Debra
Boniuk, his daughter and legal counsel to his charitable
foundation, as his representative. In addition, two of the
Company’s Scientific Advisory Board members, namely Dr. Harmon
Aronson, and Professor Thomas Lentz, also attended the meeting.
The Company has unveiled its completely redesigned website in
time for the annual meeting. The new website provides access to the
CEO’s presentation, our press releases, our technologies, as well
as our SEC filings and other documents. This website is built with
modern technologies including CSS and HTML5 to allow flexible
design and simplifying future updates.
After the business portion of the meeting was concluded, Dr.
Eugene Seymour, the Company’s CEO, reviewed the Company’s
achievements over the previous year. Of note, the Company has
successfully up-listed to the NYSE MKT exchange in September. The
listing to NYSE MKT followed a uniform reverse split comprising
conversion of each 3.5 old common stock instruments to 1 new common
stock instrument(s). The prior existing warrants were automatically
adjusted in price and in number in accordance with the uniform
reverse split. Concomitantly, the Company also successfully raised
approximately $9.7M, with a total financing of approximately $18M
over the year. The Company’s rate of cash expenditure continues to
be low, at about $1.75M in the most recent quarter. The Company had
approximately $22M in cash and cash-like instruments in hand as of
September 30, 2013. The Company estimates that this funding is
sufficient for approximately two years worth of operations. The
available funding is estimated to be sufficient for initial human
clinical trials of FluCide and possibly of DengueCide as well,
depending upon several factors outside of the Company’s
control.
The Company added two new marquee directors to its Board this
year, leading to a majority of independent directors, prior to the
up-listing. The Company also adopted strong corporate governance
policies.
The Company’s drug development programs continue to progress
satisfactorily. The broad-spectrum injectable FluCide™
anti-influenza drug is our most advanced drug candidate. Recently,
the Company has announced that FluCide was found to be safe and
well tolerated in a small non-GLP safety-toxicology study, even at
the maximum feasible dosage level. In addition, the Company has
successfully performed studies on the scale up of synthesis of
FluCide.
In addition, DengueCide™, the Company’s broad-spectrum drug
candidate against all dengue viruses and dengue fever, DHF, and DSS
was awarded an “orphan drug” status by the US FDA as well as the
European Medicines Agency (EMA). These designations bring
substantial benefits, financial, and otherwise, that have enabled
the Company to give high priority to the development of this drug
candidate. DHF (dengue hemorrhagic fever), and DSS (dengue shock
syndrome) are very severe manifestations of dengue virus infection
with fatality rates in excess of 20% worldwide.
Further, the construction of a cGMP facility for pilot-scale
production of the Company’s nanoviricide® drug candidates in
Shelton, CT, has commenced, after completing design, architecture,
and engineering. The Company intends to lease this facility in
order to minimize capital expenditures. This project is on track
with construction scheduled to be completed in first calendar
quarter of 2014. The facility is designed as a state-of-the-art,
high-tech biotechnology and nanomedicines R&D laboratory as
well as a highly customizable c-GMP capable pilot scale
manufacturing facility.
This facility is the very first and only nanomedicines
manufacturing facility in the State of Connecticut, and one of the
very few in the entire world. The facility is expected to be
capable of producing any of the Company’s nanoviricides drug
candidates, whether injectables, oral formulations, skin creams,
lotions, eye drops, or other forms, in quantities needed for human
clinical trials.
Other milestones included the signing of non-disclosure
agreements with the Lovelace Respiratory Research Institute as well
as with the Public Health England for testing of our drug
candidates against various subtypes of Influenza viruses, as well
as against the deadly Middle-East Respiratory Syndrome Coronavirus
(MERS-CoV).
Dr. Seymour’s presentation was made available on our newly
redesigned website at the time of the meeting.
Following Dr. Seymour’s presentation, Dr. Diwan provided an
overview of the Company’s platform technology and the built in
capabilities that enable the current generation of nanoviricides
drugs. Because a nanoviricide is expected to work directly against
the virus particle, it can be added to current therapies that
interrupt virus lifecycle inside the cell. Such combination is
expected to result in much stronger antiviral effect than that of
either the current therapy or the nanoviricide alone. This is
possible because a nanoviricide’s putative mechanism of action is
orthogonal to that of antiviral drugs that work inside host
cells.
More importantly, nanoviricides drugs are designed such that
viral mutations are unlikely to cause resistance to the
nanoviricide, because despite all genetic changes, how the virus
binds to the host cell receptor does not change.
NanoViricides Pipeline
NanoViricides is developing broad-spectrum anti-influenza drugs
as part of its rich drug pipeline. The Company believes that its
FluCide™ drug candidates will be effective against most if not all
influenza viruses, including the H7N9 bird flu, H3N2 or H1N1
epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as
novel influenza viruses. This is because FluCide is based on the
Company’s biomimetic technology, mimicking the natural sialic acid
receptors for the influenza virus on the surface of a nanoviricide®
polymeric micelle. It is important to note that all influenza
viruses bind to the sialic acid receptors, even if they rapidly
mutate. The FluCide drug candidates have already shown strong
effectiveness against H1N1 and H3N2 influenza viruses in highly
lethal animal models. The injectable FluCide drug candidate has
shown 1,000X greater viral load reduction as compared to
oseltamivir (Tamiflu®), the current standard of care, in a highly
lethal influenza infection animal model. The Company believes that
these animal model results should translate readily into
humans.
NanoViricides has also developed an oral drug candidate against
influenza. This oral version was found to be dramatically more
effective than oseltamivir (TamiFlu®) in animals given a highly
lethal level of influenza virus infection. This oral FluCide may be
the very first nanomedicine that is effective when taken by
mouth.
In addition, NanoViricides has developed drug candidates against
Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown
strong effectiveness in relevant animal and/or cell culture
models.
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating
special purpose nanomaterials for viral therapy. The Company's
novel nanoviricide® class of drug candidates are designed to
specifically attack enveloped virus particles and to dismantle
them. The Company is developing drugs against a number of viral
diseases including H1N1 swine flu, H5N1 bird flu, seasonal
Influenza, HIV, oral and genital Herpes, viral diseases of the eye
including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue
fever, and Ebola virus, among others.
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
pre-clinical 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.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
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