NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company"), reports
that it has filed its financial year end annual report (Form 10-K)
with the Securities and Exchange Commission (SEC) on Monday,
September 29, 2014. The report can be accessed at the SEC website
(http://www.sec.gov/Archives/edgar/data/1379006/000114420414058463/0001144204-14-058463-index.htm).
The Company had approximately $36.7 million (M) cash in hand and
approximately $1.9M in prepaid expenses and security deposits at
the end of the reported period, June 30, 2014, as compared to a
cash and cash equivalents balance of approximately $15.4M one year
ago. Research and development expenses for this year were
approximately $5.13M compared to $4.30M for the year ended June 30,
2013. General and administrative expenses were $3.54M for the year
ended June 30, 2014, compared to $3.21M for the previous year.
We became eligible for listing on major US national stock
exchanges as a result of steps taken in improving our executive
team and corporate governance except for the stock price criteria.
We performed a uniform reverse split of our securities, at a 3.5 to
1 ratio to attain full eligibility for up-listing, on September 10,
2013. Concomitantly, we also performed a registered direct
financing of approximately $10.33 million, with net proceeds to the
Company of approximately $9.6 million, after deducting expenses and
fees.
The Company’s shares began trading on the New York Stock
Exchange MKT on September 25, 2013, under the stock symbol,
“NNVC”.
On January 24, 2014, we completed a registered direct offering
and raised gross proceeds of approximately $20M before estimated
expenses of approximately $1.2M, net proceeds of approximately
$18.8 Million.
Subsequent to the reporting period, in July, 2014, the Company
accepted a subscription in the amount of $5,000,000 for a 10%
Series C Convertible Debenture from Dr. Milton Boniuk, a member of
the Company’s Board of Directors, as reported previously.
Additionally, on September 5, 2014, we accepted warrant
exercises for the purchase of an aggregate of 2,136,655 shares of
the Company’s Common Stock for an exercise price of $3.50 per share
for aggregate proceeds of $7,478,292. This warrant exercise
corresponds to the old warrants for which we had filed a
registration statement on Form S-3 on July 17, 2014, which became
effective on August, 1, 2014. All warrants specified under this
Form S-3 that were not exercised earlier, have now expired. No
brokers or consultants were engaged and no commissions or fees were
paid during this warrant exercise other than expenses.
With these transactions, we now have estimated cash in hand of
approximately $48.6M. With this strong balance sheet, we now have
sufficient funds in hand to advance our first drug, Injectable
FluCide™, for treatment of hospitalized patients with influenza
through at least the initial human clinical trials. In addition,
given our current rate of expenditure, and projected low costs of
clinical trials provided that FluCide is as successful in humans as
it has been in small animals, we believe that we may have
sufficient funds in hand to advance one more drug candidate into
advanced preclinical and possibly first in human studies.
The Company has made significant progress in the production of
its Injectable FluCide drug candidate for hospitalized patients
with severe influenza. In particular, we have been able to
successfully scale up the batch size to as much 200g in our current
facility. This amount was determined to be sufficient to begin
certain animal safety/toxicology studies. We anticipate this
material to be shipped for these studies very soon. We have engaged
BASi Toxicology Services, West Lafayette, Indiana, to perform our
IND-enabling safety/toxicology studies.
We are happy to report that the construction of our state of the
art, modern, cGMP capable, clinical scale, multipurpose,
nanomedicines manufacturing facility at 1 Controls Drive, Shelton,
CT, was completed in June, 2014, while managing customized
equipment delivery schedules and some weather-related delays. We
are now completing the special equipment fit-out modifications. We
have contracted out the facility validation to a third party.
Informally, we have started working in the new facility. Once the
facility validation is complete, we intend to move most of our work
in a phased manner over the next year or so to the new facility in
order to minimize impact on our ongoing projects. The facility was
built by Inno-Haven, LLC, which is managed by Dr. Anil Diwan, who
is also our President and Founder. Dr. Diwan raised funding for
this project from personal funds, certain sales of his NNVC
founder’s stock under a 10b(5) plan in 2011, and loans and other
borrowings from certain other private individuals over time. In
2011, Dr. Diwan took the risk of building a state of art
nanomedicines manufacturing facility on his own, independently,
with the intention of performing contract manufacturing for third
parties as well as for NanoViricides. At that time, NanoViricides
did not have the financial strength necessary for undertaking such
a capital-intensive project. Later, in February, 2013,
NanoViricides, Inc. signed a Memorandum of Understanding with
Inno-Haven for the total renovation of the 1 Controls Drive,
Shelton, CT, facility purchased by Inno-Haven into a pilot scale
cGMP facility and R&D laboratory space as per NanoViricides
specifications.
After NanoViricides had raised significant amounts of funds this
year, and with input from expert consultants, in July, 2014,
NanoViricides Board of Directors unanimously determined that it was
in the best interests of the Company and its shareholders to
acquire this state-of-the-art nanomedicines manufacturing facility
from Inno-Haven. We anticipate executing and consummating a
Contract of Sale for the facility with Inno-Haven in the near
future.
The Company recently restarted our anti-Ebola drug development
program, in response to the current Ebola epidemic raging in West
Africa that continues to expand geographically and grow
exponentially in spite of the strong efforts by the international
community. There are no drugs or vaccines available for this
infection, although some vaccines or drugs are being accelerated in
clinical trials. The limitations of current anti-Ebola drug and
vaccine development approaches are well known. Given the rapid
mutation rate observed for the current Ebola virus, vaccines,
antibodies, siRNA, and antisense RNA drugs based on previous
strains of Ebola virus can be generally thought to have limited
applicability, even if they succeed initially. In contrast, the
nanoviricides® approach of developing a drug that imitates the
sites to which the virus binds, no matter how much it mutates, is
promising. In addition, if a successful drug candidate results, we
believe that our production capacity would be responsive to the
current requirements for the containment of the Ebola epidemic in
West Africa.
In June 2013, with an improved cash position, we were able to
re-engage our anti-Dengue drug development program. This drug
candidate has received an orphan drug designation with the US FDA
in August 2013, and with the European Medicines Agency (EMA) in
November 2013. The orphan drug designation carries substantial
benefits with it that could result in significant financial
benefits to NanoViricides if the drug passes through the regulatory
processes successfully. Additionally, in the USA, we can also
expect to be issued a Priority Review Voucher (PRV). The PRV may be
applied to fast track the development of another one of our drugs
or can be sold to another pharmaceutical company for the same
purpose.
The Company now has six commercially important drug development
programs in its pipeline, addressing a market size estimated to be
in the range of $40 Billion to $70 Billion by various estimates. We
are currently focusing on advancing our Injectable FluCide™ drug,
for the treatment of severely ill, hospitalized, influenza
patients, towards an IND filing. We have also developed an Oral
FluCide drug that continues to advance following the injectable
version. Both of our FluCide drug candidates are “broad-spectrum”,
i.e. they are expected to be able to combat most, if not all,
influenza viruses, including bird flu, high path influenzas,
epidemic influenzas, seasonal influenzas, and potentially any novel
influenza A strains. The Company is also developing DengueCide, a
broad-spectrum drug that is designed to be active against all four
major serotypes of dengue viruses. HIVCide™ is a drug in
development against HIV/AIDS that shows the promise of becoming a
“Functional Cure” against HIV/AIDS, based on available animal
studies data in the standard humanized mouse model of HIV-1
infection in human T cells. This model is known to be predictive of
successful anti-HIV drug development. In September, 2013, the
Company reported that it has further improved its HIVCide drug
candidate(s) in an SAR (“structure-activity-relationship”) program.
The Company is also developing a single topical solution
nanoviricide to attack most viral infections of the eye including
Epidemic Kerato-Conjunctivitis (EKC) and Herpes Keratitis. In
addition, the Company is also developing a drug against Oral “Cold
Sores” and Genital Herpes.
“We now have a c-GMP compliant manufacturing facility for the
clinical scale production of any of our drug candidates,” said Anil
R. Diwan, PhD, President and Chairman of the Company, adding, “As
this facility becomes productive, we will gain the ability to move
our drug candidates into the human clinical trials in a rapid
succession. ”
“With almost $50M in hand, we are in an excellent financial
position,” said Eugene Seymour, MD, MPH, adding, “We are now
confident that we will be able to take our first drug, FluCide,
into human clinical trials on our own.”
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating
special purpose nanomaterials for viral 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.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
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