SHELTON, Conn., May 22, 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 third quarter of financial year 2018 in a timely
manner with the Securities and Exchange Commission yesterday. This
press release should be read in conjunction with the Form 10-Q
filed on May 21, 2018. The submission
can be downloaded from the SEC website at:
https://www.sec.gov/Archives/edgar/data/1379006/000114420418030083/tv492966_10q.htm.
The Company reported that it had approximately $10.95 Million (M) of current assets (cash, cash
equivalents, and prepaid expenses), and current cash liabilities of
2.29M, as of March 31, 2018, the end of the reporting
period.
The net cash used in operating activities during the last nine
months (three quarters) was approximately $4.26 M, compared to $6.89M in the nine months ending March 31, 2017. The difference from prior
period is primarily due to accounts payable and reduction in
operating expenditures in current period. The Company's research
and development (R&D) expenditure of approximately $1.03M in the current quarter was in line with
our budgeted estimates. Shareholder equity stood at approximately
$19.1M 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 reports that its HerpeCide™ program is advancing
satisfactorily towards our first IND filing in the near future. The
Company has reported that a preliminary rat toxicology study of two
of its lead candidates in this program that are developed against
the shingles indication was completed recently. Both of the tested
candidates were found to be extremely safe in this study.
Success in this study has paved the way for taking a clinical
candidate towards the GLP Safety/Toxicology study required for
filing an IND application.
No clinically observable adverse safety and toxicology effects
were seen in this study of the Company's optimized topical dermal
drug candidates. There were no adverse effects on the skin at the
treatment sites. Equally importantly, the results of the non-GLP
safety and toxicology study showed that there were no overall
observable systemic effects either. There were no observable direct
effects on the primary organ function whether the drug was
administered to the skin or administered systemically. This
includes liver and kidney function. This is important as the liver
and kidneys are major organs involved in drug toxicity.
These results are consistent with the positive findings in a
model of VZV (the shingles virus) infection of human skin in which
no safety or toxicology concerns have been observed, further
demonstrating the safety of these drug candidates.
These drug candidates have shown strong effectiveness in
shingles virus infection studies in human skin organ culture model
as well, as previously reported. Further, these candidates have
demonstrated strong anti-viral activities against HSV-1, HSV-2, and
VZV in cell culture studies using multiple cell lines.
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 re-estimated that
approximately 750g 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 the capabilities for producing such large
quantities of the drug substance in our current cGMP-capable
production facilities.
The Company is developing drugs against several indications in
the HerpeCide program, that are based on the tested drug
candidates. These indications include: (1) skin cream for the
topical treatment of shingles (VZV or chickenpox virus); (2) skin
cream for the treatment of "cold sores" (HSV-1); (3) skin
cream/ointment for the treatment of genital ulcers (HSV-2); (4) eye
drops/gel for the treatment of external eye viral infections,
primarily herpes keratitis (mainly HSV-1); (5) intraocular
injection for the treatment of retinal diseases caused by viral
infection (primarily VZV and HSV-2), such as ocular herpes and
viral Acute Retinal Necrosis (v-ARN). Of these, the shingles
program is currently the most advanced towards an IND filing, with
HSV-1 and HSV-2 skin cream/ointment programs following on its
heels. All of our animal studies and skin studies are done
externally. The timelines of our programs thus inherently depend
upon the external collaborations.
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 overall
market size for the indications in development in our HerpeCide
program may be estimated in the several tens of billions of
dollars.
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 believes that it will complete negotiations of a
license for the shingles field from TheraCour after our new CEO is
appointed. TheraCour has in the past not denied any licenses for
any virus programs that we initiated. Nevertheless, we will
accelerate our work on the HSV-1 (cold sores) and HSV-2 (genital
ulcers) indications, if we cannot come to an agreement with
TheraCour for the shingles license. The Company already has
licenses from TheraCour for these indications. The topical drug
candidates in development for HSV-1 and HSV-2 programs are very
closely related to the ones in development for the shingles program
at present.
The Company's search for a new CEO with strong pharmaceutical
industry background was begun prior to Dr. Seymour's retirement. It
has been accelerated and the Executive Search Committee reports
that it is now in due diligence phase, to be completed soon. In the
interim, the Board has appointed Anil R. Diwan, PhD, President and
Chairman, as the acting CEO in January, following retirement of Dr.
Eugene Seymour.
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,
as is the case with most if not all non-revenue innovative
pharmaceutical companies.
The Company has a continuity of leadership in place after Dr.
Seymour's retirement, with the temporary appointment of Dr. Diwan
as the interim CEO. Dr. Diwan and Dr. Seymour together previously
constituted the Executive Committee, and thus, Dr. Diwan has been
involved in strategic decision-making, as well as fund-raising
activities since the founding of the Company. The company's
executive committee works with the senior leadership and additional
consultants to develop and execute the Company's business strategy
and activities.
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.