SHELTON, Conn., Feb. 10, 2016 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), filed its quarterly report
in a timely manner with the Securities and Exchange Commission on
Tuesday, February 9th. The submission
can be downloaded from the SEC website at
http://www.sec.gov/Archives/edgar/data/1379006/000114420416079966/v429785_10q.htm.
NanoViricides reported that it had approximately $28.3 Million (M) of current assets plus
restricted cash (cash, cash equivalents, collateral advance,
prepaid expenses, and security deposits) as of December 31, 2015, the end of the reporting
period. The net cash used in operating activities during this
quarter was approximately $1.22M.
Shareholder equity stood at approximately $28.38M for the quarter (unaudited figures). The
Company does not anticipate any major capital expenditures in the
near future.
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, as well as to advance at least one more
drug candidate drug candidate towards initial human clinical
trials. The Company's expenditures during the reported period were
on track with this expectation.
NanoViricides, Inc. is one of a few bio-pharma companies that
have all the capabilities needed from research and development to
marketable drug manufacture in the small quantities needed for
human clinical trials. With the completion of and relocation to our
new campus at 1 Controls Drive, Shelton,
CT, we now possess 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 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).
With the recent success of our anti-HSV drug development
program, the Company has re-prioritized to focus on topical drug
development against several indications related to infections by
herpes family viruses. These topical drugs are expected to provide
a significantly faster path to human clinical stage than injectable
drugs.
In the HerpeCide™ program, the Company is currently developing
drugs against four different topical indications, namely: (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).
The Company is in the process of establishing additional
collaborations towards IND-enabling development of drug candidates
for these indications. Of these, the Company has announced on
February 1, 2016, that it has entered
into an agreement with the University of
Wisconsin for the evaluation of its nanoviricides® drug
candidates in models of ocular herpes virus infections. The studies
will be performed in the laboratory of Dr. Curtis Brandt, an expert in herpes simplex virus
infections and in evaluating anti-viral agents. The Company has
previously reported the successes of its nanoviricides drug
candidates in pre-clinical studies of dermal herpes virus
infections in mouse models. The goal of these studies will be to
identify a drug development candidate as a treatment for ocular
keratitis in humans caused by herpes simplex virus infections.
Ocular infections with HSV-1 have been reported to be the
leading cause of infectious blindness in the developed world.
Corneal transplants to replace the damaged cornea cost about
$15,000-25,000. The Company believes
that the market for an effective ocular herpes keratitis drug could
explode to several hundred millions of dollars. The Company
believes that it has sufficient production capacity at its current
site to supply the US requirement of the drug for treatment of
(ocular) herpes keratitis upon drug licensure.
The Company continues to work on its anti-influenza drug
candidates in parallel to its HerpeCide program. We are currently
developing Injectable FluCide™ for hospitalized patients with
severe influenza as our first, broad-spectrum anti-influenza drug
candidate. We have demonstrated the very first effective orally
available nanomedicine, namely oral FluCideT™ for out-patients with
influenza. The development of Oral FluCide is expected to follow
behind Injectable FluCide.
Because of our limited resources, we have assigned lower
development priorities to other drug candidates in our pipeline
such as DengueCide™ (a broad spectrum nanoviricide designed to
attack all types of dengue viruses and expected to be effective in
the Severe Dengue Disease syndromes including Dengue Hemorrhagic
Fever (DHS) and Dengue Shock Syndrome (DSS)) and HIVCide™ (a
potential "Functional Cure" for HIV/AIDS).
NanoViricides believes that it would be able to rapidly develop
a drug candidate against the recent epidemic Zika virus by
leveraging its Dengue drug efforts. Zika belongs to the same class
of viruses as dengue viruses, called flaviviruses. Therefore, we
believe that our broad-spectrum anti-dengue drug candidates would
provide good leads for Zika drug development, should resources for
engaging in this activity become available.
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.
"We continue to make steady progress towards our goal of
initiating human clinical trials of our first drug candidate in the
near future," said Eugene Seymour,
MD, MPH, CEO of the Company, adding, "And we believe we will be
able to perform clinical trials of at least one drug candidate with
our available cash resources."
The Company reports that all of its drug development programs
are progressing satisfactorily and that it will continue to provide
updates as appropriate.
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.
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SOURCE NanoViricides, Inc.