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 with some
weather-related delays. The Company reports that the R&D lab
section of the facility is ahead of schedule. Once construction of
the cGMP Clean Room Production Suite is completed, the project will
enter the facility testing and validation phase. The Company is
performing certain scale-up studies and production of the
quantities of FluCide™ needed for the “Tox Package” study at its
current facility, as previously reported. The Company anticipates
transitioning staff to the new facility upon obtaining a
Certificate of Occupancy.
The new facility project was started by Inno-Haven, LLC, a
company whose member, Dr. Anil R. Diwan is also the co-founder of
NanoViricides. Dr. Diwan purchased a building in Shelton, CT, in
August, 2011, using personal savings as well as funds raised from
sale of a portion of his founder’s NNVC stock.
“By 2011, when Dr. Diwan went all out and bought the Controls
Drive property, we had spent several years searching for a third
party contract manufacturer, capable of producing our drug
candidates under the rigorous standards required for clinical
trials, without success,” said Eugene Seymour, MD, MPH, adding,
“NanoViricides continued to search for available contract
manufacturing capability even after Diwan’s purchase of the
Controls Drive property. Most facilities we interviewed could not
manufacture our novel polymer molecules without extensive
renovations. The cost of such custom renovations and equipment
would be passed on to us, as is customary. In addition, we would
have to train their technicians and scientists and transfer
important know how and other aspects of our intellectual
property.”
NanoViricides, Inc., asked Inno-Haven to handle total renovation
of this facility, under guidelines, design and architecture to be
provided by the Company, in October 2011. The total renovation
project went through many changes of design and scope to fit the
budget. Dr. Diwan raised funds for the construction project from
high-risk-rated personal loans and other private sources. After a
long design, engineering and architecture phase, preparatory work
including identification of subcontractors, obtaining quotes, and
eventually the identified demolition work, began around February,
2013. Construction began in earnest around August, 2013, as
previously reported by the Company. Though generally on schedule,
the recent severe winter weather has delayed delivery of certain
specialty equipment necessary for the cGMP Clean Room and has
created some construction delays.
The Company signed a Memorandum of Understanding with
Inno-Haven, LLC, in January, 2013, to lease the facility with an
option to purchase. The final lease was due to be signed by March
2013. This date was extended at the request of the Company.
Following the successful debenture financing of $6M raised in
February, 2013, the Company began to evaluate the possibility of
purchasing the facility.
“With our registered direct offering in September, 2013, and the
additional raise of $20M that we completed in January, 2014, we are
now in a strong position to be able to purchase the building
outright,” said Dr. Eugene Seymour, CEO of the Company, adding, “I
delayed signing of the lease because I always believed that the
Company would be better served if it owned the facility rather than
leased it.”
Dr. Diwan, and Ms. Meeta Vyas, have abstained from, and will
continue to abstain from, NanoViricides' decision-making process
with respect to this facility, pursuant to the Company’s strong
corporate governance practices. This practice of eliminating
potential conflict of interest concerns, and many other safeguards,
have always been in force at NanoViricides, Inc.
The Company has also continuously strived to improve its
corporate governance practices. We started as a “Pink Sheet”
company upon a reverse merger with a public shell, in June 2005. We
met or exceeded all requirements for becoming a fully SEC-reporting
and filed a form 10-SB with the SEC in November, 2006. We underwent
an extensive review by SEC and FINRA subsequently, and in June,
2007, we became an SEC-reporting company and our stock began to be
quoted on OTC-BB. Prior to 2011, the Company was not subject to the
internal Controls provisions of the Sarbanes-Oxley Act (SOX).
However the Company planned on up-listing to a national exchange
and took the necessary steps to meet the requirements of SOX and
the further listing requirements of the national stock exchanges.
The Company strengthened its corporate governance by appointing
Meeta R. Vyas, (MBA-Finance, Columbia, SB-ChemEng-MIT), an
accomplished ex-CEO of a public company, as the interim CFO in May,
2013, as a culmination of our efforts in separating the roles and
responsibilities. Until then, Dr. Seymour, our CEO also served as
our interim CFO. In addition, the Company also appointed three new
independent board members, one in June, 2012, and two more in June,
2013, thereby completing its transition to a fully independent
board. The Company has undergone and passed SOX audits as well as
audits by our public accounting firm (which is itself audited
biennially by the PCAOB). In addition, the Company underwent
scrutiny by the New York Stock Exchange (NYSE) MKT Listing
Committee before our common stock became listed on NYSE MKT on
September 25, 2013. Furthermore, as a NYSE MKT listed company,
NanoViricides continues to be under regulatory and compliance
scrutiny of the Exchange.
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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