SHELTON, Conn., May 11, 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, May 10th. The submission can
be downloaded from the SEC website at www.sec.gov .
NanoViricides reported that it had approximately $25.9 Million (M) of current assets (cash, cash
equivalents, and prepaid expenses) as of March 31, 2016, the end of the reporting period.
The net cash used in operating activities during this quarter was
approximately $2.4M. The Company's
research and development (R&D) expenditure has increased as we
advance towards human clinical trials. The increase in cash
expenditures in this quarter as compared to the previous one was
primarily due to the receipt and payment of certain invoices in
this quarter corresponding to R&D accomplished in the prior
quarter. The Company estimates the current quarterly cash
expenditure rate to be about $1.9M
per quarter. Shareholder equity stood at approximately $24M 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 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). However, we now have our own capabilities to perform initial
cell culture based drug candidate screening for BSL2 viruses. We
believe that this will speed up our drug development programs
against such viruses significantly by removing the latencies of
external testing in the earlier drug screening and the later drug
optimization stages.
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 has achieved animal studies efficacy proof of
concept for treating HSV-1 skin infection using its topical
HerpeCide treatment. The Company believes that the broad-spectrum
nature of these drug candidates should allow effectiveness against
related herpesvirus types such as HSV-2 as well as the more
distantly related HHV-3 aka VZV or chickenpox/shingles virus.
The Company has established additional collaborations towards
IND-enabling development of drug candidates against the four
indications listed above. We now have collaboration agreements with
the CORL at the University of
Wisconsin, the Campbell Lab at the University of Pittsburgh, and the Pflugfelder Lab
at the Baylor College of Medicine, for
the evaluation of its nanoviricides® drug candidates in models of
ocular herpesvirus and adenovirus infections. TransPharm
Preclinical Solutions, a CRO, will continue to perform testing of
our anti-herpes drug candidates in dermal infection
models.
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.
In the United States,
approximately 1 million cases of shingles (i.e. zoster) occur
annually. The risk of zoster increases with age, and with decreased
immune system function. Zoster is characterized by pain and rash.
One in four patients experience zoster-related pain that lasts more
than 30 days, with several developing post-herpetic neuralgia (PHN)
that persists for years. Severe shingles, especially in the
elderly, and the follow-on PHN, are a major cost burden to the
society. The Company believes that our topical HerpeCide therapy
would enable control of the viral outbreak, and this control would
lead to a significant reduction in PHN cases. With the aging
population, the Company expects Zoster and PHN treatment to become
very large markets if an efficacious drug is developed.
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 FluCide™ for out-patients with
influenza. The development of Oral FluCide is expected to follow
behind Injectable FluCide.
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-Herpesvirus 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," 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
that 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.. 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.