WEST HAVEN, Conn. -- (Business Wire)
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.
Contacts:
NanoViricides, Inc.
Amanda Schuon, 310-550-7200
info@nanoviricides.com
Source: NanoViricides, Inc.
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