SHELTON, Conn., Sept. 29, 2017 /PRNewswire/
-- NanoViricides, Inc. (NYSE American: 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
Thursday, September 28, 2017 in a
timely manner. The report can be accessed at the SEC website
(https://www.sec.gov/Archives/edgar/data/1379006/000114420417050412/v474679_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.
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.
The Company's most advanced pre-clinical drug candidate is our
anti-VZV nanoviricide for the topical treatment of shingles, being
developed as a skin cream. In cell culture studies, it was as much
as five times more effective than acyclovir, the current standard
of care. The Company presented these studies in a poster entitled
"Novel Nanoviricides® Highly Effective Against
Varicella Zoster Virus in Cell Culture" at the 36th Annual Meeting
of the American Society of Virology (ASV) on June 26th, 2017. The ASV Meeting was hosted and
held at the University of Wisconsin-
Madison, from June 24th to 28th,
2017
(https://extensionconferencecenters.uwex.edu/asv2017/).
These anti-VZV drug candidates have also shown strong
effectiveness in studies involving VZV infection of human skin
patches ex vivo. These studies were conducted by Professor
Moffat at the SUNY Upstate Medical
Center. The Company is now conducting additional studies for
declaration of a clinical candidate for the treatment of
shingles.
The Company is also performing chemistry, manufacturing and
controls (CMC) related studies that are necessary for producing
large scale drug API (active pharmaceutical ingredient) batches
under the US FDA cGMP and ICH guidelines. These studies are being
performed at our campus in Shelton,
CT. We have successfully scaled up several synthetic and
processing steps to 200g~500g scales, and some steps to even
kg-scale. We believe that ~500g batch would be sufficient for the
safety/toxicology studies of our shingles drug candidate. We also
believe that the Phase I human clinical trials would require
similar quantities. We are therefore focused on producing the
shingles drug candidates at ~500g batch scale at present.
The Company reported that, as of June 30,
2017, we had cash and cash equivalent balance of
$15,099,461 that is expected to be
sufficient to fund our currently budgeted operations for more than
one year. Property, plant and equipment stood at $13,776,561 (net of accumulated depreciation of
$2,505,501). Long term Liabilities
were approximately $2M, as the
derivative value of outstanding warrants. Current liabilities stood
at $4,665,518, which include the
debenture C held by one of our directors, Professor Milton Boniuk, MD. Shareholder equity stood at
$20,321,942.
In comparison, as of June 30,
2016, we had cash in hand of approximately $24.38M; Property, plant and equipment stood at
approximately $11.76M (net of
accumulated depreciation of approximately $1.85M); while Long term Liabilities were
approximately $6.94M and the
Shareholder Equity stood at about $23.05M.
During the reporting period we spent $7,897,746 in cash toward operating activities.
In contrast, we spent ~$7.3M in cash
toward operating activities in the previous year.
On February 8, 2017 two Holders of
the Company's Series B Debentures elected to convert $5,000,000 of the principal into restricted
common stock of the Company. One of the holders is an entity
controlled by Dr. Milton Boniuk, the
Company's Director, and another holder is a charitable foundation
established by him. A third holder elected to redeem the principal
balance of $1M in cash. With this
transaction the Company effectively raised cash financing of
$5M in exchange for restricted
stock.
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 one year. 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 project, based on various estimates that we have
obtained, that our current available financing is sufficient for
accomplishing the goal of filing at least one IND or equivalent
regulatory application for at least one of our drug candidates. We
believe that we will need to raise additional financing for
conducting the clinical trials to get our first drug licensed by
the US FDA or another regulatory authority so that we can enter
commercial revenue-producing stage of our business plan. We believe
that clinical trials for our lead candidate (shingles treatment)
would be relatively less expensive being a topical treatment, as
opposed to our injectable drugs in development.
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, 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 continue
to expand the number of indications in this program as
opportunities arise, to take advantage of the synergies arising due
to its broad-spectrum anti-herpes drug development candidates.
Currently, we are targeting four different indications, 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. Expansion to additional
indications such as viral acute retinal necrosis (vARN) are likely.
vARN is caused primarily by HSV-2 and VZV, and may be neonatally
acquired. It leads to extreme decrease in visual acuity and may
lead to blindness. Treatment of vARN is an unmet medical need,
although some clinical approaches exist.
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 has several
other drug candidates in its pipeline, such as anti-HIV
nanoviricide (HIVCide™), broad-spectrum anti-dengue nanoviricide
(DengueCide™). All of these programs are at a low
priority, based on their drug development costs, length of drug
development programs, and the Company's available resources.
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 new facility contains a kg-scale c-GMP-capable manufacturing
facility that is capable of producing any of our nanoviricides,
whether oral, skin cream or injectables. 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.
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.
In addition to attacking the virus itself, 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. We believe that we will continue to
develop substantially improved drugs against the viruses we target
by utilizing these additional features of the technology after we
have advanced our current drugs into licensure.
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.