SHELTON, Conn., Feb. 27, 2019 /PRNewswire/ -- NanoViricides, Inc.
(NYSE MKT: NNVC) (the "Company") a global leader in the
development of highly effective antiviral therapies based on a
novel nanomedicines platform (the "Company"), announced today that
it has entered into a securities purchase agreement with certain
institutional investors providing for the purchase and sale of
6,944,446 units at a price of $0.36
per unit. Each unit comprises 1 share of common stock and 1
five-year warrant exercisable at $0.61.
Chardan acted as the placement agent in connection with the
financing. The closing of the sale of the securities is expected to
take place on or about February 27,
2019, subject to the satisfaction of customary closing
conditions.
The shares of common stock and warrants were offered pursuant to
a shelf registration statement on Form S-3 (File No. 333-216345),
which was declared effective by the United States Securities and
Exchange Commission ("SEC") on April 25,
2017.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy, nor will there be any sales of
these securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of such jurisdiction.
A prospectus supplement relating to the shares of common
stock will be filed by the Company with the SEC. When
available, copies of the prospectus supplement, together with the
accompanying prospectus, can be obtained at the SEC's website at
www.sec.gov or from Chardan Capital, LLC, 17 State Street, NY, NY
10004, New York, New York 10022,
by calling 646-465-9028.
The Company believes this financing provides valuable capital
that will immediately help the Company advance its drug pipeline
into human clinical trials.
Recently, on February 4, 2019, the
Company has announced that it has selected a clinical candidate for
further development under the HerpeCide™ broad-spectrum drug
program. The candidate, called "NV-HHV-101" is now in IND-enabling
cGLP Safety/Toxicology studies in the regulatory pathway. Its first
indication is for the treatment of shingles rash as a dermal
topical cream. In addition, our drug candidates against HSV-1 "cold
sores" and HSV-2 "genital herpes" are in advanced studies and are
expected to follow the shingles drug candidate into human clinical
trials. Shingles in adults and chicken pox in children is caused by
the same virus, namely VZV (Varicella-zoster virus, aka HHV-3 or
human herpesvirus-3). Topical application has the advantage of
being able to deliver very high drug concentrations locally to
completely eradicate the virus. In contrast, the local
concentrations and therefore effectiveness of orally delivered
medications is limited by the toxicity and bioavailability of the
oral drug, as is known for the existing antiviral therapies for
HSV-1, HSV-2, and VZV.
The overall market addressed by the HerpeCide program is in tens
of billions of dollars. in particular, there is currently no
effective treatment for shingles. The market size for an effective
anti-shingles drug is currently estimated to be in the range of
billions of dollars, even after a new shingles vaccine, Shingrix®
(GlaxoSmithKline) has been approved.
The Company has substantially de-risked this program towards
clinical success. We have already performed successful safety
assessments in a non-GLP preliminary safety/toxicology study
against two precursor candidates that led to NV-HHV-101 in a
standard rat animal model. In these studies, the candidates were
found to be extremely safe, with no evidence of dermal topical or
systemic adverse events.
We scaled up production after achieving these strong safety
signals, to get ready for the IND-enabling cGLP Safety/Toxicology
studies and the Phase I human clinical trials, at our own facility.
This enabled rapid translation to regulatory development, minimized
cost outlays, saved time, and improved quality assurance, as
compared to going to an external contract manufacturing
organization ("CMO"). Also, this strategy has de-risked the
manufacture by keeping it in the hands of experts who developed the
scalable chemistries and performed the scale-up operations.
The Company develops its class of drugs, that we call
nanoviricides®, using a platform technology. This approach enables
rapid development of new drugs against a number of different
viruses. A nanoviricide is a "biomimetic" - it is designed to "look
like" the cell surface to the virus. The nanoviricide® technology
enables direct attacks at multiple points on a virus particle. It
is believed that such attacks would lead to the virus particle
becoming ineffective at infecting cells. Antibodies in contrast
attack a virus particle at only a maximum of two attachment points
per antibody. In addition, the nanoviricide technology also
simultaneously enables attacking the rapid intracellular
reproduction of the virus by incorporating one or more active
pharmaceutical ingredients (APIs) within the core of the
nanoviricide. The nanoviricide technology is the only technology in
the world, to the best of our knowledge, that is capable of both
(a) attacking extracellular virus, thereby breaking the reinfection
cycle, and simultaneously (b) disrupting intracellular production
of the virus, thereby enabling complete control of a virus
infection.
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 oral and genital
Herpes, viral diseases of the eye including EKC and herpes
keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV,
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 preclinical 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.