SHELTON, Conn., Oct. 11, 2016 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), reports that it has filed
its financial year end annual report (Form 10-K) with the
Securities and Exchange Commission (SEC) on Friday, September 16, 2016 in a timely manner.
The report can be accessed at the SEC website
(https://www.sec.gov/Archives/edgar/data/1379006/000114420416124276/v447590_10k.htm.)
NanoViricides, Inc. is a global leader in the application of
nanomedicine technologies to the complex issues of viral diseases.
The nanoviricide® 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.
Our anti-viral therapeutics, that we call "nanoviricides®" are
designed to look to the virus like the native host cell surface to
which it binds. Since these binding sites for a given virus do not
change despite mutations and other changes in the virus, we believe
that our drugs will be broad-spectrum, i.e. effective against most
if not all strains, types, or subtypes, of a given virus, provided
the virus- binding portion of the nanoviricide is engineered
appropriately.
This year, the Company has focused on advancing its pre-clinical
drug candidates in the HerpeCide™ program into clinical trials in
the most expeditious manner. The Company believes it will be
pursuing four different indications in this program, namely, (1)
skin cream for the treatment of shingles, (2) skin cream for the
treatment of HSV-1 "cold sores", (3) skin cream for the treatment
of HSV-2 genital ulcers, and (4) eye drops for the treatment of
herpes keratitis (HK), an ocular infection. In addition, the
Company continues to work on its preclinical candidates in the
FluCide™ broad-spectrum anti-influenza program, namely (5)
Injectable FluCide™ for hospitalized patients with severe
influenza, and (6) Oral FluCide for our-patients with influenza.
The Company also continues work on its (7) DengueCide™
broad-spectrum anti- dengue virus therapeutic, and (8) HIVCide™
broad-spectrum anti-HIV therapeutic.
All of these drug candidates have previously shown strong
effectiveness as well as very high safety in preclinical studies
which include cell culture based studies as well as animal studies.
The Company's platform technology enables rapid drug development
against many other viruses as well. Further, we believe
NanoViricides may be the first company to have shown very high
bioavailability of its nanomedicines when given orally.
Our drug programs address a market size in the range of
$40 Billion to $70 Billion by various
estimates. We are thus poised for strong growth with a number of
drug candidates in a number of disease indications.
The Company re-prioritizes its programs based on its available
funding and input from experts with a view towards near term
opportunities for revenue generation. The Company believes
that the topical treatments in the HerpeCide program would be both
faster and easier for pre-IND package development, and thus for
entering into human clinical drug development phase
This year, we have moved our operations to the new campus in
Shelton, CT. This new 18,000+ soft
facility in Shelton, CT houses a
production scale-up laboratory, a large chemistry synthesis lab,
and more than 180 linear feet of advanced, state of the art
analytical instrumentation lab for nanomedicines characterization.
The facility also has a virology laboratory for cell culture based
characterization of anti-viral effects of our drug candidates.
Our new facility also contains a kg-scale c-GMP-capable
manufacturing facility that is capable of producing any of our
nanoviricides, whether oral, skin cream or injectables.
This year our new virology laboratory has received Biological
Safety Level 2 certification from the State of Connecticut. Our in-vitro virology
lab became fully operational circa March, 2016. This enables
preliminary screening of a much larger number of drug candidates
in-house, enabling more rapid identification and optimization of
viable drug candidates than what has been feasible with our
contract relationships in the past. The Company does not have any
animal studies facilities, and depends upon external contracts and
collaborations for the same.
This year, we have engaged several additional collaborators to
help us advance our HerpeCide and FluCide programs towards IND
filings. These include the CORL at the University of Wisconsin, Madison, WI, the Campbell
Lab at the University of Pittsburgh,
Pittsburgh, PA, and the St. Jude
Children's Research Hospital, Memphis,
TN, among others.
We believe that our new facility makes NanoViricides unique in
development stage pharma companies in that we now possess fully
integrated drug development capability from design/discovery,
synthesis, characterization, scaling up for clinical drug
development, and c-GMP-capable manufacturing to support initial
market entry, when licensed, for any of our nanoviricides drug
candidates.
The Company reported that, as of June 30,
2016, we had $24,162,185 in
hand, and additional assets of $219,458 in the form of prepaid expenses, other
assets and security deposits. Property, plant and equipment stood
at $11,760,767 (net of accumulated
depreciation of $1,850,816) and with
additional equipment purchases. Long term Liabilities were at
$6,841,190 and the Shareholder Equity
stood at $23,048,214 as of
June 30, 2016. In comparison, as of
June 30, 2015, we had cash in hand of
approximately $31,467,748 and
additional assets of approximately $214,425. As of June 30,
2015, Property, plant and equipment stood at $11,962,648 (net of accumulated depreciation of
$1,534,203) and with additional
equipment purchases, while Long term Liabilities were at
$11,800,327 and the Shareholder
Equity stood at $31,785,867.
During the reporting period we spent $7,300,530 in cash toward operating activities
and approximately $476,368 in capital
investment. In contrast, we spent $6,212,332 in cash toward operating activities
and approximately $5,760,109 in
capital investment during the previous year. We do not anticipate
any major capital costs going forward in the near future. Based on
the current rate of expenditures (excluding capital costs), we
believe that we have sufficient funds in hand to last more than two
years. In addition, in order to conserve cash expenditures, we also
pay compensation in stock and stock instruments to various
parties.
Thus, the Company has ended the year on a strong financial
footing. We have not engaged in any additional raises after the old
warrant conversion that closed in September
2014. We believe that we will not need to raise additional
capital in the very near future. We project, based on various
estimates that we have obtained, that our current available
financing is sufficient for accomplishing the goal of filing one or
possibly two IND or equivalent regulatory applications, and initial
human clinical trials in at least one of our drug programs.
"We have made substantial progress in this financial year, with
our new state of the art, c-GMP manufacturing capable campus, and
further progress in our HerpeCide program which is now at advanced
pre-clinical stage," said Eugene
Seymour, MD, MPH, adding, "The topical HerpeCide program is
developing in parallel with our injectable FluCide. The HerpeCide
program is currently moving faster towards clinical trials, because
of the inherent advantages in the nature of topical drug
development."
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. IND =
Investigational New Drug Application to the US FDA. Other
regulatory bodies have similar applications that need to be filed
prior to beginning human clinical studies.
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.
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SOURCE NanoViricides, Inc.