SHELTON, Conn., Feb. 16, 2017 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), filed its quarterly report
for its second quarter of financial year 2017 in a timely manner
with the Securities and Exchange Commission on Tuesday, February 14th. The submission can be
downloaded from the SEC website at
https://www.sec.gov/Archives/edgar/data/1379006/000114420417009000/v458345_10q.htm.
NanoViricides reported that it had approximately $19.44 Million (M) of current assets (cash, cash
equivalents, and prepaid expenses) as of December 31, 2016, the end of the reporting
period. The net cash used in operating activities during this
quarter was approximately $2.6 M. The
Company's research and development (R&D) expenditure has
increased as we advance towards human clinical trials. Shareholder
equity stood at approximately $19M
for the quarter (unaudited figures). The Company also reported
that, subsequent to the reporting period, holders of $5,000,000 principal value Series B
Convertible Debentures, namely, an entity controlled by Dr.
Milton Boniuk, a director of the
Company, and The Boniuk Charitable Foundation, had converted
$5,000,000 of Series B debentures
into equity, and the remaining $1,000,000 principal, with accrued interest as of
the maturity date, was repaid to the holders thereof in cash.. The
Company believes that its offer to the debenture holders to convert
at a rate based on the Company's recent stock price performance was
in the best interests of its shareholders, as it bolsters the
Company's available capital for executing on its current business
plan.
The Company estimates that it has sufficient cash in hand to
last more than one year of operations at the current rate of
expenditure. The Company estimates that the cash in hand is
sufficient to enable us to perform initial human clinical trials of
at least one of our drug candidates. The Company's expenditures
during the reported period were on track with this expectation.
The Company said it has focused its work on studies needed for
moving the shingles topical treatment towards human clinical trials
stage as rapidly as it can. The Company is performing the
Chemistry, Manufacture and Controls (CMC) studies needed for filing
an Investigational Drug Application (IND) with the US FDA or
equivalent application(s) in other countries including Australia, for the shingles drug candidate. In
parallel, the Company is performing studies needed to finalize a
clinical drug candidate out of several that have shown strong
success in cell culture studies. There is no standard animal model
for shingles.
The Company has eight different drugs in development, including
four indications in the HerpeCide program. This deep and wide
pipeline demonstrates the robustness of the nanoviricide® platform
technology.
In the HerpeCide™ program, the Company is currently developing
topical drugs against: (a) skin cream/lotion for the topical
treatment of "cold sores" (typically caused by HSV-1); (b) eye
drops/gel for the treatment of ocular herpes keratitis (mostly
caused by HSV-1, sometimes by HSV-2 primarily in neonates); (c)
skin cream/lotion for the treatment of "genital lesions" caused by
herpesvirus (typically HSV-2); and (d) skin cream/lotion for the
treatment of shingles (caused by HHV-3 also known as VZV, i.e. the
chickenpox virus).
NanoViricides has engaged Professor Moffat's Lab at the
State University of New York Upstate Medical
Center (SUNY-UMC) in Syracuse
for studies of these shingles drug candidates in cell culture and
in a human skin patch model of VZV infection. We believe that these
human skin patch studies should be highly predictive of human
clinical trials success.
NanoViricides, Inc. is one of a few bio-pharma companies that
has all the capabilities needed from research and development to
marketable drug manufacture in the small quantities needed for
human clinical trials. Our new campus at 1 Controls Drive,
Shelton, CT, has state of the art
nanomedicines characterization facilities that enable us to perform
IND-enabling nanomedicine analysis and characterization studies of
any of our various drug candidates in house.
All current topical drug candidates in our HerpeCide™ program
are variants of the shingles drug further optimized for the
specific herpesvirus and topical delivery constraints. These
topical treatments are expected to provide a significantly faster
path to human clinical stage than the injectable and oral drugs in
our pipeline.
Topical treatments for the herpesvirus indications are
important. Although the herpesviruses stay latent in a nerve
ganglion, the pathology of an outbreak in a patient begins with
reinfection in the skin layer from the reactivated virus, followed
by further expansion of the virus in the skin layer. The newly
produced virus then causes additional spread of the virus to more
nerve cells, and would become latent there. Topical nanoviricide®
treatment would stop further expansion of the virus at the site and
therefore should also potentially decrease further recurrences.
Also, topical treatment allows exposure of the virus to much higher
concentrations of the drug locally, and thereby should produce
greater effectiveness with less overall drug use, as compared to
systemic treatments.
There is no effective treatment for shingles and the shingles
related PHN (post-herpetic neuralgia). The
shingles associated debilitating pain usually lasts during the
infection outbreak in most patients, but in some patients,
PHN can develop, which can last 90 days to even a year in some
cases after the skin has healed. Approved treatments for shingles
and PHN include acyclovir related nucleoside analogs that are given
in very high doses systemically for a week but with limited effect.
A new nucleoside analog called FV-100 is in Phase 3 clinical
trials. FV-100 development was previously abandoned by
Bristol-Myers-Squibb and is now undertaken by a small pharma.
There is also a vaccine for shingles that may reduce occurrence
of shingles as a preventive, but not as a treatment after an
outbreak occurs. Another vaccine is in development. The chickenpox
vaccine is now standard for children. However, the incidence of
shingles in adolescents and young adults is rising, although
shingles generally occurs in older people due age related decrease
in immune function, and in patients with immune function
compromising conditions from stress to organ transplant to other
infections and HIV/AIDS.
Although in most patients shingles is debilitating during the
outbreak but not life-threatening, in a small percentage of
patients, it can cause eye infections that can lead to
blindness.
There is no topical treatment for shingles. We believe this is
an unmet medical need. The market size for a successful topical
treatment for shingles could be in the billion dollar range.
All of the biological testing and characterization of our drug
candidates continues to be performed by external academic or
institutional collaborators and contract research organizations
(CRO). However, we now have our own capabilities to perform initial
cell culture based drug candidate screening for BSL2 viruses, which
includes herpesviruses. We believe that this is speeding up our
drug development programs against such viruses significantly by
removing the latencies of external testing in the earlier drug
screening and the later drug optimization stages.
The Company has established additional collaborations towards
IND-enabling development of drug candidates against the four
HerpeCide program indications listed above. We now have
collaboration agreements with the CORL at the University of Wisconsin, and the Campbell Lab at
the University of Pittsburgh, for the
evaluation of its nanoviricides® drug candidates in models of
ocular herpesvirus and adenovirus infections. TransPharm
Preclinical Solutions, a CRO, will continue to perform testing of
our anti-herpes drug candidates in dermal infection models. In
addition, we have a collaboration with Professor Moffat Lab at SUNY-UMC to study our drug
candidates against shingles.
The nanoviricides® mechanism of action is believed to mimic a
natural host cell receptor using which the virus binds and infects
cells; binding of a nanoviricide nanomicelle to the virus is
expected to render it non-infectious. A nanoviricide would thus
stop the spread of the viral infection to new uninfected cells.
This mechanism is different from that of currently available
anti-Herpesvirus drugs. The Company therefore believes that it is
able to develop broad-spectrum anti-herpes nanoviricide drugs.
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
that 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.. 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.