SHELTON, Conn., May 18, 2015 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), filed its quarterly report
in a timely manner with the Securities and Exchange Commission on
Friday, May 15th. The submission can
be downloaded from the SEC website at
http://www.sec.gov/Archives/edgar/data/1379006/000114420415031364/v410164_10q.htm.
The Company estimates that it now has approximately $34.3 Million (M) of current assets plus
restricted cash (cash, cash equivalents, collateral advance,
prepaid expenses, and security deposits) as of March 31, 2015, the end of the reporting quarter.
The Company's operating expenditure during this quarter was
approximately $1.12M. Shareholder
equity stood at approximately $31.86M
for the quarter.
The Company estimates that the cash in hand is sufficient to
enable us to perform initial human clinical trials of our
injectable FluCide™ drug candidate, as well as possibly to advance
another drug candidate towards initial human clinical trials.
The Company reports that the process of commissioning of its new
facility in Shelton is on course.
Our Bio-Analytics Group has already moved operations to the new
facility. Large Scale Chemistry Group is completing the necessary
modifications to the facility. We implemented a phased program for
commissioning the new facility. This has enabled us to continue to
progress in all of our existing programs, without
interruptions.
The Company reports that all of its drug development programs
are progressing satisfactorily and that it will continue to provide
updates as appropriate.
Scale-up of the FluCide™ anti-influenza drug candidate is
progressing well. We are continuing the CMC studies (see below) on
FluCide production processes. These studies are necessary to enable
further scale-up from the current multi-100g scale of production to
kg-scale production of our nanoviricides drug candidates. The
1kg-scale production is being set up at our new Shelton, CT facility and headquarters.
In April 2015, subsequent to the
reporting period, the Company reported that its anti-Herpes
nanoviricides drug candidates demonstrated dramatic effectiveness
in a lethal mouse model of dermal herpes infection. The reported
studies were performed in Professor Ken
Rosenthal's laboratory at the NorthEast Ohio Medical
University ("NEOMED").
The Company reported that topical dermal treatment with two of
its anti-herpes nanoviricides formulations led to almost complete
(>85%) survival of the lethally infected mice in this animal
model. In contrast, animals treated with an acyclovir formulation
exhibited significantly lower survival rates (<58%) even though
it was employed at twice the human dosage concentration; and all
untreated mice died of the disease. The nanoviricides treatment
also led to dramatic improvements in clinical symptoms associated
with herpes simplex virus infection. The effect of these
nanoviricides was consistent with a significant reduction in HSV-1
production in vivo, possibly by inhibition at an early stage.
The Company believes that the drug approval process for a
topical herpes treatment could be relatively rapid, based on the
strong effectiveness results. The Company intends to meet with its
FDA advisory consulting group, namely, Biologics Consulting Group,
Inc., to chart out the path towards approval. In addition, the
Company intends to engage a Contract Research Organization (CRO)
for further development of a topical anti-herpes drug into the
regulatory approval pathway for US FDA as well as internationally.
The Company intends to study various indications including HSV-1
cold sores, HSV-2 genital lesions, Herpes keratitis (an eye
disease), and Shingles, among other possibilities.
The market size for herpes virus treatments is in excess of
$2 billion annually. The Company
believes that a drug that is superior to existing therapies could
result in significantly expanded market size, as has been
demonstrated in the case of HIV, Hepatitis C and other diseases. An
estimate of over $40 billion for an
effective anti-herpes drug may not be excessive, considering the
near-complete penetration of the various herpesviruses in human
population, and the repetitive and debilitating nature of illnesses
that they can cause.
In just four cycles of further improvements the Company has now
reached its goal of substantially complete survival in the highly
lethal animal model of dermal herpesvirus infection (HSV-1 H129c
strain), wherein no current drugs have shown substantial survival
effect. Our anti-herpes program began in 2009, and we immediately
observed dramatic viral load reduction (>99.9%) in cell
cultures. Nevertheless, due to financial constraints, this program
continued to be on the back burner. This and many of our other
programs were accelerated following up-listing in 2013 to the
NYSE-MKT exchange which enabled us to raise significant
funding.
The recent anti-HSV small animal studies employed the HSV-1
H129c strain. This highly neurotropic strain is derived from a
patient. It is known to be far more virulent than other HSV-1
strains that have been used in drug and vaccine development against
herpes viruses. The Company had previously reported that its
earlier anti-HSV drug candidates had exhibited greater than 99.9%
viral load reduction in cell culture studies employing the HSV-1
McCrae strain, indicating that these nanoviricides are
broad-spectrum anti-herpes agents.
Professor Rosenthal retired last year and continued as Professor
Emeritus at NEOMED. Even after his retirement, he continued his
research, and was personally involved in on-going studies of
nanoviricides drug candidates in his laboratory. Professor
Rosenthal has now joined Roseman University of Health Sciences,
Las Vegas, Nevada, as a Professor
of Biomedical Sciences. He will continue as a consultant to
NanoViricides for our anti-herpes drug development program. He is a
leading researcher in herpes virus anti-viral agents and
vaccines.
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-Herpes drugs. The Company therefore believes that it is able
to develop broad-spectrum anti-herpes nanoviricide drugs.
Initial cell culture testing of our drug new candidates against
Ebola virus that was completed recently at a BSL-4 facility in the
USA indicated that a further
improvement in the effectiveness of these drug candidates in cell
cultures is needed in view of current guidelines for advancing into
animal studies. From previous experience with many of our programs,
we are aware that our nanoviricide® drug candidates, which are
based on a whole systems-biology-based approach, do not fare well
in the cell culture assays that are optimized for testing of small
molecules, even as they have demonstrated extremely high
effectiveness and safety in animal models. It is also likely that
the NPC1-binding site on Ebolavirus glycoprotein, which is thought
to be buried, may have been substantially inaccessible to our drug
candidates. We believe that we can substantially improve the
effectiveness and thereby produce a highly effective,
broad-spectrum, drug candidate against Ebola/Marburg in a few
cycles of optimization. We believe USAMRIID will continue to be our
collaborator for testing the new drug candidates for such
optimization. We are looking for potential funding for this program
from non-dilutive sources.
We are now progressing to a 1kg scale-up of FluCide, and
enabling in-process control instrumentation. We need to make
approximately 2.5Kg of our FluCide drug candidate for further Tox
Package studies because of the excellent safety demonstrated by
this drug candidate in safety and toxicology studies in both mouse
and rat animal models. CMC stands for "Chemistry, Manufacture, and
Controls," and relates to being able to make the drug substance and
the drug product in a reproducible fashion, batch after batch. CMC
programs for nanomedicines are relatively complex compared to those
of small molecules. We have focused on developing scalable,
reproducible processes from the very onset, which has helped us
minimize the process development time.
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
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 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.
Logo - http://photos.prnewswire.com/prnh/20150107/167444LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html
SOURCE NanoViricides, Inc.