SHELTON, Conn., May 16, 2017 /PRNewswire/
-- NanoViricides, Inc. (NYSE MKT: NNVC)
(the "Company"), filed the quarterly report for its third quarter of financial year 2017 in a timely manner with the Securities
and Exchange Commission on Monday, May 15th. The submission can be downloaded from the SEC website
at https://www.sec.gov/Archives/edgar/data/1379006/000114420417027501/v466096_10q.htm .
NanoViricides reported that it had approximately $16.74 Million (M) of current assets (cash,
cash equivalents, and prepaid expenses) as of March 31, 2017, the end of the reporting period. The
net cash used in operating activities during this quarter was approximately $2.7M, consistent with
previous quarter. Shareholder equity stood at approximately $22.4M for the quarter (unaudited
figures). The increase in shareholder equity was the net effect of the conversion of Series B convertible debentures that matured
on January 31, 2017, as previously reported. Briefly, 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, 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, on or about. 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 its lead drug development program, namely topical skin cream for the treatment of shingles, is progressing
satisfactorily, under its HerpeCide™ project. The drug candidates being advanced in the shingles program are variations of the
drug candidates that were found to be highly effective against HSV-1 H129 in a lethal animal study with 80-100% of treated
animals surviving fully as opposed to untreated animals showing 0% survival, as previously reported.
The Company is pursuing at least four different indications with these drug candidates in its HerpeCide™ program, namely, (1)
skin cream for the treatment of shingles caused by reactivation of the chickenpox virus (VZV, aka HHV-3), (2) skin cream for the
treatment of cold sores (herpes labials) caused by the herpes simples virus-1 (HSV-1), (3) skin cream for the treatment of
genital ulcers caused by HSV-2, and (4) topical eye drops for the treatment of herpes keratitis (mostly caused by HSV-1).
The Company recently reported that it has completed certain preliminary ex vivo human skin patch based efficacy studies
for its initial drug candidates against shingles, and repeat studies to confirm the results are in progress. These studies
were conducted in the laboratory of Professor Moffat at the State University of New York Upstate Medical
Center in Syracuse, NY. The Company expects to report on these studies upon approval of
the study investigators and their Institute. Further studies towards declaration of the final clinical drug candidate for
shingles are continuing. We believe that these human skin patch studies should be highly predictive of human clinical trials
success.
The Company said its work on the scale-up of manufacturing of the drug candidates in the HerpeCide project is advancing
successfully. We are currently working on production at approximately 200g to 500g scales. The Company has recently estimated,
with its service providers and industry expert consultants, that a quantity of approximately 1kg of drug candidate will be
sufficient for its proposed Safety/toxicology studies for the shingles drug candidate. The Company is on course to have the
ability to produce such quantities in its own manufacturing facility once a clinical drug candidate is declared.
The Company has continued to focus 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 the four indications in the HerpeCide program described above.
This deep and wide pipeline demonstrates the robustness of the nanoviricide® platform technology.
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 other 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 a
breakout 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.