SHELTON, Conn., Nov. 10, 2015 /PRNewswire/ -- NanoViricides, Inc.
(NYSE MKT: NNVC) (the "Company"), filed its quarterly report in a
timely manner with the Securities and Exchange Commission on
Monday, November 9th. The submission
can be downloaded from the SEC website at
http://www.sec.gov/Archives/edgar/data/1379006/000114420415063679/v422773_10q.htm.
The Company estimates that it had approximately $29.7 Million (M) of current assets plus
restricted cash (cash, cash equivalents, collateral advance,
prepaid expenses, and security deposits) as of September 30, 2015, the end of the reporting
period. The net cash used in operating activities during this
quarter was approximately $1.65M,
with an additional approximately $0.33M towards purchase of property and
equipment. The Company reported a net loss of $0.02 per share for the quarter. Shareholder
equity stood at approximately $30.71M
for the quarter. 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 reports that its HerpeCide™ program is advancing
well. We anticipate developing topical drugs to control herpesvirus
outbreaks for a number of indications under this program. These
include oral lesions or "cold sores", usually caused by HSV-1,
genital lesions, usually caused by HSV-2, and shingles outbreaks in
adults, caused by reactivation of the chickenpox virus (varicella
Zoster virus, or HHV-3). In addition, the Company is also
developing eye drops for the treatment of herpes keratitis (HK) of
the eye, and for epidemic adenoviral conjunctivitis (EKC). The
Company believes, assuming the results from our animal studies are
indicative of future human clinical success, that these various
drug candidates under the HerpeCide program should result in
extremely effective drugs.
The Company believes, based on various professional inputs it
has obtained, that the different topical herpesvirus treatments
would move towards the clinical stage faster than our Injectable
FluCide™ for hospitalized patients. This is based on the limited
studies needed for safety/toxicology, as well as for efficacy, for
a topical drug against herpesviruses, as opposed to an injectable
drug against the highly variable influenza viruses.
We continue to work on Injectable FluCide in parallel with the
HerpeCide program drug candidates.
The Company has completed its transition to its new facilities
at 1 Controls Drive, Shelton, CT.
With this state of the art facility, NanoViricides, Inc. is now one
of the very few small pharma drug developers that possess their own
clinical quality drug manufacturing operations. NanoViricides now
has the facilities to design, synthesize, scale-up, and manufacture
any of our drug substances for IND submissions and for human
clinical trials, and also has the capability to manufacture
sufficient drug substance for initial market entry when the drug is
licensed. The new facilities include a state of the art, highly
customizable, c-GMP-capable drug production suite with clean rooms
for the production of injectable drugs in multi-kilogram batches.
(IND = "investigational New Drug", c-GMP = "current Good
Manufacturing Practice"). All of the biological testing of our drug
candidates continues to be performed by external collaborators.
The Company believes that the drug substance requirement for any
of the topical herpecide drug candidates would be in the range of a
few hundred grams. The Company has already scaled up certain
production steps to 200g scale or better, and the remaining steps
are being scaled up, while developing appropriate process controls
and characterization methods alongside. Thus the Company believes
it will soon have the ability to produce the HerpeCide drug
candidates in quantities sufficient for the safety/toxicology
studies, and will be able to make similar quantities of
c-GMP-quality material later for human clinical trials when
needed.
The Company continues further work to scale up the production to
500g, 1kg and larger batch quantities as feasible in the new
facility. Injectable FluCide safety/toxicology studies have been
estimated to require more than 2kg of material.
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.
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.
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-2015-09-30-300175612.html
SOURCE NanoViricides, Inc.