SHELTON, Conn., Feb. 21, 2018 /PRNewswire/ -- NanoViricides, Inc.
(NYSE MKT: NNVC) (the "Company") a global leader in the
development of highly effective antiviral therapies based on a
novel nanomedicines platform (the "Company"), filed its quarterly
report for its second quarter of financial year 2018 in a timely
manner with the Securities and Exchange Commission on Tuesday, February 20, 2018. The submission can be
downloaded from the SEC website at:
https://www.sec.gov/Archives/edgar/data/1379006/000114420418009768/0001144204-18-009768-index.htm.
This press release should be read in conjunction with the Form
10-Q filed on February 20, 2018.
The Company reported that it had approximately $12.0 Million (M) of current assets (cash, cash
equivalents, and prepaid expenses) as of December 31, 2017, the end of the reporting
period. The net cash used in operating activities during the six
months (two quarters) was approximately $2.96 M, compared to $4.84M in the six months ending December 31, 2016. The difference from
prior period is primarily due to accounts payable, which were
approximately $1.55M in current
period compared to $0.48M in the
prior period, and reduction in operating expenditures in current
period. The Company's research and development (R&D)
expenditure of approximately $1.4M in
the current quarter was in line with our budgeted estimates.
Shareholder equity stood at approximately $15.9M for the quarter (unaudited figures). The
Company had no revenues.
The Company has no long term debt.
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 has stated that it will be required to
raise additional capital in the near future to fund our drug
candidates as they advance towards IND stage and into human
clinical trials.
The Company has begun an initial safety and toxicology
evaluation of its optimized nanoviricides® drug candidates
developed against varicella-zoster virus (VZV), the shingles virus,
as reported previously. This preliminary safety/toxicology study in
the rat animal model is an important step in the drug development
pathway for a treatment for shingles, a debilitating infection of
human skin by VZV. The results of this study are expected to help
us finalize the clinical lead. In addition, these results are
expected to lead to refining and commissioning the GLP safety and
toxicology study ("Tox Package" study) as required for filing an
IND.
We believe, additionally, that the results of this preliminary
rat safety/tox study will also be applicable to the dermal topical
treatments we are developing for the treatment of HSV-1 cold sores,
and HSV-2 genital ulcers.
Subsequent to this reporting period, the animal experiment
portion of this study has been completed as of the end of
January 2018. We have received
initial verbal communications that indicate that our drug
candidates were non-toxic in terms of behavioral and other
observable signs during the study. We are awaiting a final report
from the CRO, which is due shortly.
We have already begun to scale up production of these tested
candidates to the larger amounts as estimated to be required for
the ensuing Tox Package studies. We have estimated that
approximately 500g of the candidate will be needed for such a
study, based on discussions with BASi, Inc., IN, the service
provider, and Biologics Consulting Group, VA, our regulatory
consultants.
We have previously reported excellent results on efficacy of the
shingles topical treatment in our HerpeCide™ program. Certain
shingles drug candidates were found to be about five times more
effective than acyclovir, the standard of treatment, in cell
culture studies. These data were presented at the 2017 Annual
American Society of Virology meeting in Madison, WI.
The same drug candidates also showed very high effectiveness in
controlling VZV (varicella zoster virus, the causative agent) in
human skin patch model for shingles in Professor Moffat's lab at
the SUNY Upstate Medical Center,
Syracuse, NY. On the basis of these results, these candidates
were advanced into preliminary animal safety/toxicology studies, as
described above. The shingles drug candidate is now moving towards
identification of a clinical candidate for further IND-enabling
studies.
The market size for anti-shingles drugs is currently estimated
to be in the range of several billions of dollars, even after a new
shingles vaccine, Shingrix® (GlaxoSmithKline) has become available,
based on a recent report by Dr. Myers of BioEnsemble, LLC, pharma
industry consultants, commissioned by the Company.
The Company believes that the anti-VZV drug candidates are very
likely to be effective for dermal topical treatment of HSV-1 cold
sores, as well genital ulcers caused by HSV-2, in addition to
shingles. If the same anti-VZV/shingles drug candidates also
demonstrate efficacy against the HSV-1 and HSV-2 animal models,
then we will be ready to go into IND applications and clinical
stage for these indications as well in relatively short time frames
of six months to a year, after the first IND filing, depending upon
the availability of funding. We had previously demonstrated
significant efficacy of an anti-HSV-1 nanoviricide in animal models
using nanoviricides based on closely related ligands and polymer
that were not yet optimized.
Thus we have made significant and substantial progress in the
reporting quarter towards the goal of filing our first IND
application, and we continue to build on this progress.
The Company is continuing the process for licensing of the
shingles indication from TheraCour Pharma, Inc.. To this end, the
Company has reviewed the initial valuation report submitted by Dr.
Myers of BioEnsemble, LLC. Thereafter, we have asked that further
modeling and analysis be performed incorporating additional
assumptions that reflect our situation more closely than in the
model that was presented. Thereafter, we anticipate license
agreements will be drafted and the terms and conditions will be
negotiated. TheraCour has in the past not denied any licenses for
any virus programs that we initiated. We have retained counsel to
prepare and negotiate the new license agreement on our behalf. If
we cannot come to an agreement with TheraCour for the shingles
license, we will continue and accelerate our work on the HSV-1
(cold sores) and HSV-2 (genital ulcers) indications, which we
believe will be using essentially the same or closely related
dermal topical drug candidates as in development under the VZV
banner at present in the HerpeCide™ program. The Company already
has licenses from TheraCour for these indications.
Additionally, the Company reported that Dr. Eugene Seymour, MD, MPH, the Company's
co-founder and CEO, has resigned from his position as CEO as well
as a Director of the Company to allow a successor with a
pharmaceutical background in shepherding drugs through the process
to FDA approval, to be appointed to serve in this capacity.
Upon entry into severance agreement Dr. Seymour will assume
the role of Chief Executive Officer Emeritus. The Board of
Directors commenced a search for a permanent replacement for Dr.
Seymour, which is ongoing. Pending the appointment of a permanent
Chief Executive Officer, the Board of Directors appointed Dr. Anil
Diwan, the Company's President, as Interim Chief Executive
Officer.
Dr. Seymour, a co-founder of the Company, has been a driving
force in building NanoViricides from a nanomedicines concept to a
Company with a broad pipeline of drug candidates as it is
today.
The Company's progress is expected to continue unaffected by the
resignation of Dr. Seymour. Dr. Diwan, who has served as the
Company's President since 2005, has assumed the additional duties
as interim CEO. Dr. Diwan has been performing several of the CEO
duties increasingly since the Company's 2013 uplisting from the OTC
Markets to NYSE-American. Further, Dr. Diwan has led several of the
Company's financing efforts with Dr. Seymour including two
registered direct offerings conducted in September 2013 and January
2014 respectively, that raised approximately $30 million.
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 oral and genital
Herpes, viral diseases of the eye including EKC and herpes
keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV,
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.
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SOURCE NanoViricides, Inc.