WEST HAVEN, Conn., Feb. 25, 2015 /PRNewswire/ -- NanoViricides, Inc.
(NYSE MKT: NNVC) (the "Company"), filed its quarterly report with
the Securities and Exchange Commission on Tuesday, February 24th. The submission can be
downloaded from the SEC website at
http://www.sec.gov/Archives/edgar/data/1379006/000114420415011553/v402511_10q.htm.
The Company estimates that it now has approximately $36.4 Million (M) of current assets plus
restricted cash (cash, cash equivalents, collateral advance,
prepaid expenses, and security deposits) as of December 31, 2014, the end of the reporting
quarter. The Company's operating expenditure during this quarter
was approximately $1.9M. Shareholder
equity stood at approximately $30.5M
for the quarter.
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 Company has reported that its anti-Ebola
nanoviricide® drug candidates have been sent for testing at a
prestigious BSL4 facility in the United
States, subsequent to the end of the reporting period. These
candidates were designed and synthesized in less than four months
utilizing our rapid drug development platform. The Company has
previously 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 its anti-Ebola drug
candidates. The Company has the ability to produce sufficient
quantities of a successful drug candidate for potential field
use.
The Company has previously reported that it completed the
acquisition of the state-of-the-art nanomedicines manufacturing
facility at 1 Controls Drive, Shelton,
CT, from Inno-Haven, LLC, by reimbursing Inno-Haven for the
costs incurred. This facility 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 has previously reported that the initial safety and
toxicology studies of FluCide™ in a rat model were completed at
BASi, Inc., subsequent to the reporting period. These studies have
continued to demonstrate an excellent safety profile for our
injectable FluCide drug candidate, at doses up to 300mg/kg given
for 14 days (total 4,200mg/kg).
In addition, the Company is performing process development and
scale up studies on its FluCide drug candidate. FluCide is designed
as a treatment for influenza in seriously ill hospitalized
patients, a potentially fatal disease for which no satisfactory
treatment exists. FluCide's excellent safety profile resulted in
the need for a very large quantity of the drug for the GLP
Safety/Toxicology studies required for an Investigational New Drug
("IND") filing. The multi-kilogram quantities of FluCide needed for
these safety and toxicology studies will be produced in the new
Shelton facility.
The Company estimates that the cash in hand is sufficient to
enable us to perform initial human clinical trials of our
injectable FluCide™ drug candidate, as well as possibly to advance
another 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 reports that it has successfully transitioned to
Eisner-Amper LLP as our new external auditing firm with this
quarterly report. During this transition, it was discovered that
the Company had inadvertently treated certain warrants issued in
relation to the registered direct offerings in September 2013 and in January 2014, and a certain Debenture issued in
July 2014, without considering
potential derivative effects related to the terms of these
instruments. Upon finding this omission, and determining that this
required restatement of certain previously filed reports, the
Company filed a current report on Form 8-K that the previously
issued Annual Report for the period ending June 30, 2014, and the recently issued quarterly
report for the period ending September, 30, 2014, could not be
relied upon.
The corresponding restated annual report and the restated
quarterly report were filed on February 23,
2014. The restatements only affected the derivative
treatment of certain warrants and certain terms of the debenture
referenced above. The Company has taken steps to improve its
internal controls to avoid such issues in the future. However, the
excessive workload associated with these restatements and the
transition from the previous audit firm to the new external audit
firm led to late filing by one day of the Company's filing of the
quarterly report for the period ending December 31, 2014.
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.
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SOURCE NanoViricides, Inc.