NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") reported
today that construction of the modern R&D Lab and cGMP Clinical
Production facility in Shelton, CT, is nearing completion on
schedule. The Company reports that the R&D lab section of the
facility is nearing completion, slightly ahead of schedule. In
addition, construction of the cGMP Clean Room Production Suite is
expected to be completed in March, 2014, on schedule, and shortly
thereafter, the project will enter facility testing and validation
phase. The Company and the project staff, including Mr. Phil Mader
and Mr. Andrew Hahn have been working diligently to keep this
complex project on time.
“Our urgency to bring this facility online has increased with
the new wave of H7N9 Influenza A infections in China this year,”
said Eugene Seymour, MD, MPH, explaining, “It is now thought that
H7N9 bird flu has at least sporadically transmitted from humans to
humans. This is the first step before the H7N9 virus gains ability
to cause an epidemic, which could become a pandemic if a
drug-resistant mutant strain of the virus takes over. Drug
resistant H7N9 has already been found in China.”
“We believe that the broad-spectrum FluCide™ should be an
excellent treatment for H7N9,” added Anil R. Diwan, PhD, President
and Chairman of the Company, explaining, “This FluCide drug
candidate was designed to mimic both the bird and human variants of
the sialic acid receptors on cells to which the influenza virus
binds. FluCide has shown extremely strong activity in animal
studies against both Group I and Group II Influenza A viruses. Thus
we fully expect it to work against H7N9.”
In late March 2013, investigators confirmed that 3 patient
deaths in China were due to a novel avian-origin influenza virus,
H7N9. Approximately 32% case fatality rate is reported from H7N9 by
the European Center for Disease Prevention and Control (ECDC;
http://ecdc.europa.eu/en/press/news/_layouts/forms/News_DispForm.aspx?List=8db7286c%2Dfe2d%2D476c%2D9133%2D18ff4cb1b568&ID=930&Web=86661a14%2Dfb61%2D43e0%2D9663%2D0d514841605d).
The Company reports that its project for enabling clinical scale
drug product cGMP capability at the Shelton facility is now nearing
completion of construction. After construction is complete, the
facility, and particularly the cGMP Clean Room Suites will undergo
facility testing and validation to ascertain that the facility
satisfies the requirements. After validation, the Company plans to
occupy the new facility while keeping the current facility active
to minimize impact on the multiple nanoviricides® drug development
projects. The Company intends to first start production of FluCide
in the cGMP section, set up appropriate cGMP operation for this
production, produce multiple batches of FluCide under cGMP
conditions, and demonstrate equivalence of the batches produced, in
preparation for human clinical trials.
Certain countries including Australia allow early human clinical
trials to be conducted using cGMP-compliant material. The Company
intends to begin human clinical trials at the earliest after
completing the Tox Package studies, and is evaluating all available
options.
Safety and toxicology studies of our injectable and oral FluCide
drugs are estimated to require very large quantities of the drugs,
because of strong safety data evidenced from our preliminary safety
study, as well as our in vivo (animal) efficacy studies to date.
The Company will be able to initiate GLP Safety/Toxicology studies
(“Tox Package”) studies of our injectable FluCide drug when the
requisite large amount of drug substance is produced at our current
facility.
In another news, the Company reports that its recently announced
registered direct offering (“Offering”) has been completed
successfully on Friday, January 24th, 2014. The Company sold
3,815,285 units and raised gross proceeds of $20,030,246.25 before
estimated expenses of approximately $1,200,000, which includes
placement agent fees but does not include and attorneys’ fees and
other expenses. The price per Unit was $5.25, equal to a four
percent (4%) discount to the 20-day VWAP of the NNVC stock price on
Friday, January 17, 2014. The exercise price of the Warrant was
equal to the closing price of NNVC stock on Friday, January 17,
2014. Each Unit consisted of one share of the Company’s common
stock, par value $0.001 per share, and 0.65 of a warrant to
purchase one share of common stock, issuable upon exercise of the
Warrant at the exercise price of $6.05 per share. The Warrants are
exercisable immediately and expire five years after issuance. The
Offering was made pursuant to the Company’s shelf registration
statement on Form S-3 (File No. 333-184626), which was declared
effective by the Securities and Exchange Commission on December 21,
2012 and Form S-3MEF (File No. 333-193439). The Company, pursuant
to Rule 424(b) under the Securities Act of 1933, has filed with the
Securities and Exchange Commission a prospectus supplement relating
to the Offering.
The Company intends to use the proceeds for general business
purposes and expects that it will be able to accelerate the
development of its drug candidate pipeline with this additional
funding. With this raise, the Company now has approximately $40
Million cash in hand (including non-current cash-based assets),
which the Company believes is sufficient for its planned activities
for the next three years and beyond. With these funds, in addition
to certain clinical trials for FluCide and DengueCide, the Company
anticipates that it will also be able to expedite development of
its four other drug candidates, namely, Oral FluCide, HerpeCide™,
HIVCide™, and EKCCide™ into the FDA approval process.
The injectable and oral FluCide drug candidates have already
shown strong effectiveness against distinctly different subtypes of
influenza viruses, namely H1N1 and H3N2, in highly lethal animal
models. This indicates that our FluCide drug candidates are
“broad-spectrum”, i.e., they should work against most, if not all,
influenza viruses. 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 oral FluCide is also
dramatically more effective than TamiFlu in these animal studies.
This oral FluCide may be the very first nanomedicine that is
effective when taken by mouth. The Company believes that these
animal model results of both injectable and oral FluCide drug
candidates should translate readily into humans.
The Company has recently signed confidentiality agreements with
both Public Health England (PHE-UK) and the Lovelace Respiratory
Research Institute, New Mexico, USA (LRRI). Both of these
institutions have the ability to perform further testing of our
FluCide drug candidates against additional influenza viruses
including H7N9. The Company intends to perform our remaining
IND-enabling studies of FluCide at these institutions.
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.
The US FDA as well as the European Medical Agency (EMA) has
recently designated DengueCide®, our drug for dengue and dengue
hemorrhagic fever as an “orphan drug” in their respective
territories.
The Company has previously reported that it has engaged
Inno-Haven, LLC, to renovate the Shelton facility as per
NanoViricides’ requirements for expanded R&D facility and a
cGMP pilot scale (kg scale) production facility including clean
room suites suitable for injectables active pharmaceutical
ingredient (API) manufacture. Inno-Haven, LLC, a private company,
is controlled by Anil R Diwan, PhD, who is also the President of
NanoViricides, Inc. Dr. Diwan sold certain amount of his NNVC stock
to finance purchase of the building that was completed in August,
2011. Further, Inno-Haven has raised substantial amounts of
additional capital for this project independently. NanoViricides
has signed a Memorandum of Understanding with Inno-Haven to lease
the facility. No lease has been signed at present.
NanoViricides, Inc. has assembled a marquee team of experienced
personnel to help us with the design, architecture, and engineering
of this facility. Mr. Andrew Hahn continues to provide overall
stewardship for this project. He was formerly Senior Director of
Engineering, Pharmaceutical Facilities, Global Engineering, at the
Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He
has almost 30 years of experience in architecture, design and
project management in the creation of new and refurbished
facilities at Bristol-Myers Squibb Company. Mr. Phil Mader and his
firm, MPH Engineering, LLC (“MPH”), continue to help with the
overall project management and design engineering of the laboratory
and cGMP pilot production facility. Prior to founding MPH, from
2000 to 2007, Phil Mader served as the Senior Capital Project
Manager at Bristol-Myers Squibb Company in Wallingford, CT (“BMS”).
He was involved in the design, implementation, and commissioning of
various biology and chemistry laboratory projects within budget and
in a timely manner. Ms. Kathyann Cowles of ID3A, LLC, serves as the
Principal Architect. Ms. Cowles, co-founder of Id3A, has
over thirty years of experience as a licensed
Architect and Senior Project Manager for diverse and complex design
and construction projects in the academic, science,
technology, corporate and research sectors.
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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