SHELTON, Conn., Oct. 15, 2018 /PRNewswire/ -- NanoViricides, Inc.
(NYSE Amer.: NNVC) (the "Company"), reports that
it has filed its annual report (Form 10-K) for the financial year
ending June 30, 2018, with the
Securities and Exchange Commission (SEC) on Friday, October 12, 2018. The report can be
accessed at the SEC website
(https://www.sec.gov/Archives/edgar/data/1379006/000114420418053665/tv501564_10k.htm)
.
The Company reported that, as of June 30,
2018, we had cash and cash equivalent balance of
approximately $7.08 Million. In
comparison, as of June 30, 2017, we
had cash in hand of approximately $15.10Million. Research and development expenses
for the year ended June 30, 2018
decreased about $700K to $4.83 Million from $5.53
Million for the year ended June 30,
2017, primarily due to reduction in payroll and consultant
costs, and related reduction in lab supplies and chemicals. General
and administrative expenses increased about $429K to $4.50
Million for the year ended June 30,
2018 from $4.07 Million for
the year ended June 30, 2017. The
increase in general and administrative expenses is generally
attributable to recognition of stock and cash compensation paid to
Dr. Seymour upon his resignation and an increase in legal,
professional and consultant costs.
For the year ended June 30,
2018, the Company had a net loss of about $8.56 Million, or a basic loss per share of
$0.13 and fully diluted loss per
share of $0.13 compared to a net loss
of about $10.3 Million, or a basic
loss per share of $0.17 and a fully
diluted loss per share of $0.17 for
the year ended June 30, 2017. This
decrease in the Company's net loss is generally
attributable to the gain resulting from the change in fair value of
derivatives, discount on convertible debenture expense, and
interest expense, which were partially offset by a loss on
extinguishment of debt from the conversion of convertible
debentures to equity in November, 2017.
During the financial year, the Company has taken steps to
strengthen its management team and its board to increase depth in
pharmaceutical industry expertise. Dr. Eugene Seymour resigned at the end of January,
2018, and his severance was formalized in May 2018. In addition, Dr. Milton Boniuk resigned as a Director of the
Company in July, 2018 due to differences with Management and Board
of the Company.
Dr. Irach Taraporewala, a 25+ years pharma industry veteran
joined the Company as its Chief Executive Officer ("CEO")
officially on September 1,
2018. Dr. Taraporewala has demonstrated expertise in QA/QC,
CMC, c-GMP production, and regulatory strategy, having taken a
novel drug through successful Phase 2 human clinical
trials.
The Company has restructured its business plan to focus on
taking its first drug candidate into human clinical trials at the
earliest possible date. The Company has redeveloped its budgets and
believes that it has sufficient funds in hand to accomplish this.
The Company anticipates raising additional capital for conducting
human clinical trials in the future. The Company believes that its
dermal topical cream for the treatment of shingles rash will be its
first drug heading into clinical trials. The Company's process of
negotiation with TheraCour Pharma, Inc. for licensing of the VZV
and potentially all remaining herpesvirus areas has begun in
earnest after the new CEO joined. The Company believes that
additional topical treatment candidates in the HerpeCide™ program,
namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers"
treatment are expected to follow the shingles candidate into
IND-enabling development and subsequently into human clinical
trials.
The Company anticipates achieving several important
milestones in the ensuing year. In brief, these include the
declaration of a final clinical candidate for its lead drug
indication, achieving successful cGMP-like production of the drug
as required for the ensuing "Tox Package" studies,
initiation and completion of the Tox Package studies, a "Pre-IND"
meeting with the FDA, filing of an IND, and the beginning of
initial human clinical trials. In general, as a pharmaceutical
company achieves these milestones, its risk-profile with investors
improves as reflected in the market capitalization. Management
believes that as the Company achieves these milestones, it would
significantly improve the Company's ability to raise
funds on the public markets. However, there can be no assurance
that the Company will achieve any of these milestones or that such
achievements will reflect favorably in the share price and market
cap metrics.
NanoViricides, Inc. is a global leader in the application of
nanomedicine technologies to the complex issues of treatments for
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 refer to as
"nanoviricides®" are designed to mimic and 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. 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
Jennifer Moffat at the SUNY Upstate Medical Center in Syracuse, NY, an internationally recognized
expert on varicella-zoster virus (VZV) infection, pathogenesis, and
anti-viral agent discovery. The work was presented at the 31st
International Conference on Antiviral Research held June 11 - June 15, 2018 in Porto, Portugal.
The Company is currently performing chemistry, manufacturing and
controls (CMC) related tasks that are necessary for producing
large-scale drug API (active pharmaceutical ingredient) batches
under the US FDA cGMP and ICH guidelines. These activities are
being carried out at our campus in Shelton, CT. We have successfully scaled up
various synthetic and processing steps up to kilogram scales. We
are currently producing kilogram-level materials for the pre-IND
enabling safety/toxicology studies of our shingles drug candidate.
We also believe that the Phase I human clinical trials would
require similar manufactured quantities. Our Shelton, CT 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 facility makes NanoViricides unique in
development stage pharma companies in that we possess fully
integrated drug development capability from design/discovery,
synthesis, characterization, scaling up for clinical drug
development, and cGMP-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 our broad and deep pipeline
enabled by our platform technology.
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, shingles and chickenpox, 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 preclinical 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. (FDA refers to
US Food and Drug Administration. EMA refers to the European Union's
office of European Medicines Agency.)
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SOURCE NanoViricides, Inc.