NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") announced
today that it has raised approximately $20 Million in a registered
direct offering. The Company will receive approximately $18.8
Million in proceeds after deducting approximately $1.2 M for broker
commissions and attorney fees.
“We were very pleased with the strong interest from select
institutional investors and existing shareholders,” said Eugene
Seymour, MD, MPH, CEO of the Company, adding, “It enabled us to
raise $20M in place of the intended $10M, taking advantage of the
20% additional allowance option for our registered securities.” Dr.
Seymour further explained, “We anticipate that the additional
capital will be sufficient to last through Phase I and II human
clinical studies of our injectable FluCide drug candidate, and also
through initial human clinical trials of DengueCide.” DengueCide
has received Orphan Drug designation by the US FDA as well as the
European Medical Agency (EMA). These designations entail
significant benefits, allowing the Company to prioritize
development of DengueCide.
With this raise, the Company now has approximately $40 Million
cash in hand (including non-current cash-based assets), which the
Company believes is sufficient for its planned activities for the
next three years and beyond. With these funds, in addition to
certain clinical trials for FluCide and DengueCide, the Company
anticipates that it will also be able to expedite development of
its four other drug candidates, namely, Oral FluCide, HerpeCide™,
HIVCide™, and EKCCide™ into the FDA approval process.
With this additional capital, the Company anticipates being able
to hire necessary staff to accommodate the expanded workload as it
gears several of its drug candidates towards IND filings over the
near future. Further, the Company will be able to continue its
R&D programs, such as nanoviricides against Rabies and
Ebola/Marburg viruses. The Company believes it will also be able to
pursue additional R&D programs such as developing nanoviricides
against the recently discovered Middle East Respiratory Syndrome
(MERS) virus (a Coronavirus), as well as other opportunities. These
programs should result in additional drug candidates in the
Company’s already robust pipeline in the near future.
The Company has recently reported that no toxicities or adverse
events were found even at the maximum feasible dose level in a
preliminary safety/toxicology study of its broad-spectrum
anti-influenza lead drug candidate, injectable FluCide. This drug
is designed for hospitalized patients with severe influenzas. The
Company expects that these results indicate that its oral FluCide
is also likely to demonstrate similarly strong safety profile.
“We believe that the safety of our entire nanoviricide class of
drugs is validated to a large extent by this safety study,” said
Anil R. Diwan, PhD, President of the Company, adding, “The
nanoviricides differ from each other primarily in the anti-viral
ligand. We now await the results of the full Safety and Tox Package
study of FluCide.” The Company is currently producing sufficient
material for the injectable FluCide tox package study. The strong
safety profile resulted in a very large quantity requirement of
test material for this study, which was beyond the Company’s
production capacity last year.
Extremely high efficacy has been demonstrated for FluCide in
highly lethal animal studies against both group I Influenza A
(H1N1) and group II influenza A (H3N2) viruses, indicating that
this drug is indeed broad-spectrum and should work against most if
not all strains of Influenza. The Company has previously reported
that injectable FluCide resulted in full 21 day survival of 100% of
animals in a highly lethal influenza virus challenge study. To
compare, 100% of Tamiflu®-treated animals died in 8 days and 100%
of untreated animals died in 5 days, in this study. The injectable
FluCide treatment resulted in a greater than 1,000-fold reduction
in lung viral load, as compared to only a less than 2-fold
reduction for Tamiflu-treated animals at the same time point in
this study. These results demonstrate the extremely high
effectiveness of FluCide against influenzas. Other nanoviricides
have shown similarly strong effectiveness in relevant animal
models. Notably, HIVCide continued to suppress viral load in
SCID-hu mice at the same level as a three-drug HAART cocktail, even
as long as 42 days after HIVCide treatment was stopped, while HAART
group continued to receive treatment. The Company expects that
these animal model results should translate readily into humans,
because the nanoviricides are designed to directly attack the virus
particle, in a host-independent fashion. The Company believes that
HIVCide could be a “Functional Cure” of HIV/AIDS.
The Company has recently signed confidential disclosure
agreements (CDA’s) with Public Health England, UK, as well as with
Lovelace Respiratory Research Institute, New Mexico, USA to further
develop FluCide towards an IND. This development will entail
testing the drug candidate against a number of additional influenza
viruses in cell culture models, as well as in animal models. The
viruses include H5N1 “Bird Flu”virus, as well as the H7N9 “Bird
Flu” virus. H5N1 is a dreaded virus with greater than 50% lethality
in humans that could become devastating if it develops pandemic
potential. The H7N9 virus recently circulating in China is also
being watched closely because millions could die if it develops
pandemic potential.
Purchase price of each unit in this offering was $5.25. This
price was set at a 4% discount to the 20-day VWAP (volume-weighted
average price) of NNVC common stock as of Friday, January 17th.
Each unit of this registered direct offering consists of 1 share of
common stock and a 5-year warrant for purchasing 0.65 shares. The
warrants have an exercise price of $6.05 per share, which was the
closing price of NNVC common stock on Friday, January 17th. Based
on similar recent transactions, the Company determined that this
was a fair pricing policy and adopted the pricing. The units were
offered by Nanoviricides pursuant to an effective shelf
registration statement on Form S-3 (File No. 333-184626) filed with
the Securities and Exchange Commission dated October 26, 2012, as
amended on December 3, 2012 and declared effective on December 21,
2012, and a registration statement filed on Form S-3 with Rule
462(b) under the Securities Act of 1933 with the Securities and
Exchange Commission on January 21, 2014. A prospectus supplement
relating to the offering will be filed with the SEC and will be
available on the SEC’s website at http://www.sec.gov.
Chardan Capital Markets, LLC, acted as lead placement agent and
Midtown Partners & Co., LLC was the co-placement agent in
connection with the offering.
The closing of this offering is expected to take place on or
before Friday, January 24th, 2014, subject to the satisfaction of
customary closing conditions. In connection with the Offering,
pursuant to a Placement Agency Agreement dated January 20, 2014,
among Midtown Partners & Co., LLC, and Chardan Capital Markets,
LLC (collectively, the “Placement Agents”), the Company paid the
Placement Agents an aggregate cash fee representing 6% of the gross
Purchase Price paid by the Purchasers and warrants to purchase an
aggregate of 2% of the number of shares of Common Stock sold in the
Offering (the “Compensation Warrants”), substantially similar to
the Warrants sold in the Offering, at an exercise price equal to
$6.05 per share.
NanoViricides Pipeline
NanoViricides is developing broad-spectrum anti-influenza drugs
as part of its rich drug pipeline. The Company believes that its
FluCide™ drug candidates will be effective against most if not all
influenza viruses, including the H7N9 bird flu, H3N2 or H1N1
epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as
novel influenza viruses. This is because FluCide is based on the
Company’s biomimetic technology, mimicking the natural sialic acid
receptors for the influenza virus on the surface of a nanoviricide®
polymeric micelle. It is important to note that all influenza
viruses bind to the sialic acid receptors, even if they rapidly
mutate. The FluCide drug candidates have already shown strong
effectiveness against H1N1 and H3N2 influenza viruses in highly
lethal animal models.
NanoViricides has developed an oral drug candidate against
influenza. This oral version is also dramatically more effective
than TamiFlu in the animals given a lethal influenza virus
infection. This oral FluCide may be the very first nanomedicine
that is effective when taken by mouth.
In addition, NanoViricides has developed drug candidates against
Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown
strong effectiveness in relevant animal and/or cell culture
models.
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, including
statements related to the sufficiency of our cash and our cash
requirements, the timing and success of our development efforts and
the relationship between the results of our current development
efforts and the success of our future development efforts. . 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.
FDA refers to US Food and Drug Administration. EMA refers to the
European Union’s office of European Medical Agency.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
NanoViricides (AMEX:NNVC)
Historical Stock Chart
From Mar 2024 to Apr 2024
NanoViricides (AMEX:NNVC)
Historical Stock Chart
From Apr 2023 to Apr 2024
