NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company"), has filed
its quarterly report with the Securities and Exchange Commission on
Thursday, November 15th, in a timely fashion. The submission can be
downloaded from the SEC website at
http://www.sec.gov/Archives/edgar/data/1379006/000114420413061915/v360486_10q.htm.
The Company reported that it had approximately $22.0M in current
assets (cash, cash equivalents, collateral advance, and prepaid
expenses) as of September 30, 2013, the end of the reporting
quarter. The shareholder equity stood at approximately $11.75M. In
comparison, the Company had approximately $15.5M in current assets
plus collateral advances, and approximately $8M in shareholder
equity as of June 30, 2013, the end of its financial year.
The Company spent approximately $1.175M in Research and
Development expenses (R&D) and approximately $714,561 in
General and Administrative expenses (G&A), including
stock-based expenses, in the reported quarter. The current rate of
expenditure was in line with the Company’s budgeted targets.
The Company reported that it had raised approximately $10.33M in
a registered direct offering on September 10, 2013, immediately
following a reverse split of its common stock at the rate of 1 new
share for 3.5 old shares effected the same day. The Company
received approximately $9.690 Million in proceeds after deducting
approximately $640K for broker commissions and attorney fees.
Midtown Capital Partners LLC and Chardan Capital Markets LLC
jointly served as placement agents for this raise.
The Company’s long term and trusted supporters (family funds)
including our Director, Professor Milton Boniuk, MD, have invested
a majority of the total funds in this raise. The Company had
undertaken the reverse split in order to enable it to be listed on
a national stock exchange.
On September 25, 2013, the Company’s (new) common stock began
trading on NYSE MKT exchange under the symbol “NNVC”. This is a
significant milestone for the Company, resulting as a culmination
of a year long effort spearheaded by its founder and chairman, Dr.
Anil R. Diwan.
The Company estimates that it currently has sufficient cash in
hand to support operations for at least two years from reported
period at the current rate of cash expenditure. NanoViricides, Inc.
also estimates that it has sufficient cash in hand to support
initial human clinical trials of its first drug candidate, a
broad-spectrum anti-influenza drug in its FluCide™ program. The
Company’s estimates are based on its current rate of expenditure
and also on certain approximate estimates for clinical development
of its drug candidate as gleaned from discussions with various
contract research organizations.
The Company reports that all of its drug development programs
are progressing satisfactorily.
Of these, our Injectable FluCide™ is the most advanced. This
drug candidate has shown extremely high effectiveness in a lethal
influenza infection mouse model against two different types of
influenza A virus, namely H1N1 and H3N2. The Company believes that
this drug should be effective against most if not all influenza A
subtypes, and strains, including the novel H7N9 strain. The Company
held a pre-IND Meeting with the US FDA for its clinical drug
candidate NV-INF-1 (i.e. Injectable FluCide) in the FluCide program
in March 2012. The Company obtained valuable advice and is
developing this candidate towards an investigational drug
application (“IND”) to the US FDA as well as for similar
applications to other international regulatory agencies. The
Company recently performed a short preliminary non-GLP study
designed to guide the planned GLP Safety and Toxicology studies
(“Tox Package”) that are required for an IND filing.
On October 7, 2013, the Company announced that in this small
animal non-GLP safety/toxicology study of NV-INF-1 drug candidate,
even at maximum feasible dosage, the drug was well tolerated and
that no adverse events were found at study completion. The Company
is awaiting a full report on the chemistry and histology data from
this study. These results are consistent with our findings during
efficacy studies of this drug candidate in lethally infected mouse
models.
The Company is currently performing scale up studies on its
FluCide drug candidate in its existing facilities. Upon scale-up,
we will be able to produce the quantities of materials we need for
the GLP Safety/Toxicology study of the injectable FluCide drug. We
intend to begin the GLP Safety/Toxicology study as soon as
feasible.
The Company has previously announced that its anti-dengue drug
candidate in the DengueCide™ program achieved an unprecedented 50%
survival rate in a special mouse model that mimics the most severe
dengue disease in humans. This study was performed by Professor Eva
Harris at the University of California, Berkeley.
On August 12, 2013, the Company announced that this anti-dengue
drug candidate has been awarded an orphan drug designation by the
US FDA. Subsequent to this quarterly report, on November 11, 2013,
we announced that this anti-dengue drug candidate was also awarded
an orphan drug designation by the European Medicines Agency (EMA).
These orphan drug designations provide the Company with several
financial and other benefits that have now enabled the Company to
give a high priority to the development of this drug.
In addition, the Company is developing a flexible,
multi-product, pilot manufacturing facility capable of
manufacturing any of its drug candidates in c-GMP compliant manner.
This facility will be able to provide the cGMP clinical drug
substances for its future human clinical studies. (“c-GMP”= current
Good Manufacturing Practices, a set of guidelines developed by the
US FDA that the manufacture of a drug must adhere to for human
clinical trials and future sales. Internationally, there are
similar guidelines promoted by local regulatory agencies, and ICH
harmonization guidelines promoted by the WHO). A group of private
financiers that includes our founder Dr. Anil Diwan has acquired an
18,000 sq.ft. building on 4 acres with possibilities of expansion,
in Shelton, CT, via Inno-Haven, LLC, a company formed specifically
for that purpose. This building is now undergoing a total
renovation to facilitate setting up a modern cGMP drug substance
manufacturing facility with injectable drugs capability, as well as
supporting analytical and chemistry laboratory facilities.The
Company reported that the renovation of the facilities at 1
Controls Drive, Shelton, CT is now in Construction phase, and is
expected to be completed in the first calendar quarter of 2014.
The Company previously held a pre-IND meeting with the US FDA
for its anti-influenza drug candidate, NV-INF-1, in the FluCide
program on March 29, 2012. The Company believes it has received
valuable input from the US FDA, applicable to the development of
its anti-influenza drug candidates.
With the current strong cash position, the Company believes that
it has sufficient funds available to perform the necessary IND
enabling studies for its anti-influenza drug programs, to file an
Investigational New Drug Application (“IND”) with the US FDA, and
to conduct initial human clinical trials of its first
anti-influenza drug. The Company’s estimates are based on
information it has obtained from reliable sources, confidential
cost estimates from consultants and service providers, and other
sources. There is no guarantee that this information is accurate.
The Company will continue to refine its estimates as the
development programs progress further.
Including the Flucide program, the Company currently has six
commercially important drug candidates in its pipeline. These
include the Injectable and Oral drugs against all Influenzas,
HIVCide™, HerpiCide™, DengiCide™, and a broad-spectrum nanoviricide
eye drop formulation against viral infections of the eye. These
programs are based on the Company’s platform technology that
enables specifically targeting a particular type of virus with a
novel mechanism of action. In addition, the Company continues its
other research and development programs. These include (a)
broad-spectrum nanoviricides against a number of Neglected Tropical
Diseases, and (b) its novel ADIF™ (“Accurate Drug In Field”™)
technologies which promise a way to attack novel viruses, whether
man-made (bioterrorism) or natural (such as SARS), before they
cause a pandemic.
On November 15, 2013, the Company has filed its Quarterly Report
on Form 10-Q for the period ended September 30, 2013. However, the
Registrant was unable to complete the financial statements in
interactive data format in eXtensible Business Reporting Language
(“XBRL”) without unreasonable effort or expense. We will amend our
Form 10-Q to provide financial statements in XBRL format within the
time prescribed for the filing.
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® 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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