WEST HAVEN, Conn., Sept. 16, 2015 /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 Monday, September 14, 2015 in a timely manner.
The report can be accessed at the SEC website
(http://www.sec.gov/Archives/edgar/data/1379006/000114420415054864/v418491_10k.htm.)
NanoViricides, Inc. is a leading company 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.
We recently completed acquisition at cost of a kg-scale
c-GMP-capable manufacturing facility for injectable nanomedicines.
This new facility in Shelton, CT
also 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.
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. All of our operations have moved to this new facility
already.
The Company reported that, as of June 30,
2015, we have $31,467,748 in
hand, and additional assets of $214,425 in the form of prepaid expenses.
Property, plant and equipment now stand at $11,962,648 (net of accumulated depreciation of
$1,534,203) with the acquisition of
the 1 Controls Drive facility at cost from Inno-Haven, and with
additional equipment purchases. Long term Liabilities were at
$11,800,327 and the Shareholder
Equity stood at $31,785,867 as of
June 30, 2015. In comparison, as of
June 30, 2014, we had cash in hand of
approximately $36,700,000 and
additional assets of approximately $1,300,000 in the form of prepaid expenses, other
assets and security deposits. As of June 30,
2014, Long term Liabilities were at $19,972,953 and the Shareholder Equity stood at
$23,369,303.
During the reporting period we spent $6,212,332 in cash toward operating activities
and approximately $5,760,109 in
capital investment. In contrast, we spent $6,333,625 in cash toward operating activities
and approximately $5,231,094 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 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 currently have more than six commercially important drug
programs in development, namely, Injectable FluCide™ for
hospitalized patients with severe influenza, Oral FluCide for
out-patients, HerpeCide™ topical treatment program, HIVCide™,
DengueCide™, and eye drops for viral infections of the external
eye, including ocular herpes keratitis and epidemic
kerato-conjunctivitis (EKC). These programs address a market size
in the range of $40 Billion to $70
Billion by various estimates.
Two of our drug programs, namely Injectable FluCide, and
HerpeCide skin cream, are now in the late pre-clinical or
IND-enabling studies stage. We anticipate that these drug
candidates will move forward into IND or equivalent regulatory
filings, and ensuing human clinical trials. As these drug
candidates are advancing into the clinic, we believe that our
additional drug candidates will also move forward into IND-enabling
studies. The HerpeCide program is likely to expand into multiple
indications that include skin cream or lotion for treatment of cold
sores, skin cream for the treatment of genital herpes lesions, skin
cream or lotion for the treatment of shingles breakouts, and ocular
herpes keratitis, to name a few. We are thus poised for strong
growth with a number of drug candidates in a number of disease
indications.
"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, and additional strong safety data on injectable
FluCide which is in IND-enabling studies," said Eugene Seymour, MD, MPH, adding, "The topical
HerpeCide program is developing in parallel with our injectable
FluCide. The HerpeCide program is likely to move 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.
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.