NanoViricides, Inc. Files Quarterly Report - Reports Further Improved Strong Cash Position Sufficient for Clinical Trials of ...
November 17 2014 - 7:00AM
Business Wire
NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company"), has filed
its quarterly report with the Securities and Exchange Commission on
Friday, November 14th, in a timely fashion. The submission can be
downloaded from the SEC website at
http://www.sec.gov/Archives/edgar/data/1379006/000114420414068843/0001144204-14-068843-index.htm
The Company reports that all of its drug development programs
are progressing satisfactorily and that it will continue to provide
updates as appropriate.
In particular, the synthesis of anti-Ebola drug candidates is
progressing satisfactorily. The Company has recently reported that
it has signed a “Cooperative Research and Development Agreement -
Materials Transfer Agreement (CRADA-MTA)” with the US Army Medical
Research Institute of Infectious Diseases (USAMRIID) for biological
testing of these candidates. The Company is working expeditiously
on its anti-Ebola program at present, in order to develop an
effective drug candidate that may be available in response to the
current Ebola epidemic crisis. The Company has the ability to
produce sufficient quantities of a successful drug candidate for
potential field use.
The Company has developed a state-of-the-art nanomedicines
manufacturing facility that will be capable of producing any of the
Company’s drug candidates in a cGMP-compliant manner in
multi-kilogram quantities. This facility will be able to provide
the cGMP clinical drug substances for the Company’s future human
clinical studies. (“c-GMP”= current Good Manufacturing Practices).
The Company’s Board of Directors has authorized acquisition of this
facility from Inno-Haven, LLC, rather than leasing it. The
acquisition process is in the due diligence phase at present, and
is expected to be concluded soon.
Initial large animal safety/toxicology studies in the Company’s
FluCide™ drug development program have begun at BASi, as previously
reported. In addition, the Company is performing process
development and scale up studies on its FluCide™ drug candidate in
its existing facilities. The scale-up studies were necessitated to
be performed at this early stage of our drug development because of
the extremely high safety of FluCide that resulted in a very large
quantity requirement for the GLP Safety/Toxicology studies. The
limitations of the current laboratory facilities impose that we
produce these materials in multiple batches at present, resulting
in extended production and characterization time periods.
The Company estimates that it now has approximately $42.6
Million (M) of current assets plus restricted cash in hand as of
the date of filing. The Company estimates that this funding is
sufficient to enable us to perform initial human clinical trials of
our injectable FluCide™ drug candidate, as well as possibly to
advance our DengueCide™ orphan drug candidate towards initial human
clinical trials. As previously reported, our strong cash position
has enabled us to restart our anti-Ebola drug development program
in response to the current epidemic. The Company’s estimates are
based on its current rate of expenditure and also on certain
approximate estimates for clinical development of its drug
candidate as gleaned from discussions with various contract
research organizations.
The Company reported that it had approximately $42.6M in current
assets plus restricted cash (cash, cash equivalents, collateral
advance, prepaid expenses, and security deposits) as of September
30, 2014, the end of the reporting quarter. The shareholder equity
stood at approximately $36.8M. In comparison, the Company had
approximately $36.7M in current assets plus restricted cash, and
approximately $28.6M in shareholder equity as of June 30, 2014, the
end of previous quarter, and our financial year. The increase in
shareholder equity and cash in hand during this quarter resulted
mainly from the exercise by existing shareholders of their old
warrants resulting in aggregate proceeds of approximately $6.74M
received prior to September 30, 2014. In addition, in July 2014,
the Company sold debentures worth $5M to an existing investor and
Board Member, Dr. Milton Boniuk, as previously reported. The
Company spent approximately $811K in Research and Development
expenses (R&D) and approximately $876K in General and
Administrative expenses (G&A), including stock-based expenses,
in the reported quarter. The current rate of expenditure was in
line with the Company’s budgeted targets.
On September 5, 2014, NanoViricides, Inc. (the “Company”)
accepted notices to exercise old warrants for the purchase of an
aggregate of 2,136,655 shares of the Company’s common stock at the
exercise price of $3.50 per share for aggregate proceeds of
$7,478,292.50. On July 17, 2014, the Company filed a registration
statement on Form S-3 (the “Form S-3”) registering an aggregate of
3,071,986 shares of common stock underlying warrants previously
issued by the Company in various private placement offerings
between 2005 and September 2009 (the “Old Warrants”), as described
more fully in the Form S-3 (the “Registered Warrants”). The Form
S-3 was declared effective by the Securities and Exchange
Commission on August 1, 2014. As of August 15, 2014, any Registered
Warrants as specified above and not previously exercised have
expired.
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.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
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