SHELTON, Conn., May 20, 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"), has filed its
quarterly report for its third quarter of financial year 2019 in a
timely manner with the Securities and Exchange Commission. This
press release should be read in conjunction with the Form 10-Q
filed on May 15th, 2019. The
submission can be downloaded from the SEC website at:
https://www.sec.gov/Archives/edgar/data/1379006/000114420419026612/tv519975_10-q.htm.
The Company reported that it had approximately $4.63Million (M) of current assets (cash, cash
equivalents, and prepaid expenses), and current cash liabilities of
approximately $1.08M, as of
March 31, 2019, the end of the
reporting period.
The net cash used in operating activities during the last nine
months (last three quarters) was approximately $5.13M, compared to approximately $4.26M in the nine months ending March 31, 2018. The Company's expenditures
were in line with budget estimates. Shareholder equity stood at
approximately $12.72M for the quarter
(unaudited figures). The Company had no revenues.
The Company has no long term debt.
The Company raised $2.5M on
February 27, 2019 in a registered
direct offering (the "Offering") of 6,944,446 shares of Common
Stock ("Shares") at the purchase price of $0.36 ("Purchase Price") per share. In a
concurrent private placement, the Purchasers received warrants (the
"Warrants") to purchase up to 6,944,446 shares of Common Stock. The
Warrants have an exercise price of $0.61 per share, shall be exercisable on the six
month anniversary of issuance and will expire five (5) years
thereafter. The Warrants are exercisable for cash or, solely in the
absence of an effective registration statement or prospectus, by
cashless exercise. The net proceeds from this offering were
approximately $2.35M after deducting
placement agent commission and agent legal fees. Chardan Capital
Markets, LLC acted as a placement agent for this
offering.
The Company is pleased to note that it has been executing on all
milestones towards the IND filing for its first clinical candidate
along a reasonable projected timeline, and is doing so with highly
conservative expenditures.
The Company is pleased to note that it has taken its first lead
drug candidate, namely NV-HHV-101 through IND-enabling non-GLP
Safety/Toxicology ("Tox Package") studies successfully, enabling
the beginning of the GLP Tox Package studies. The Company has filed
a pre-IND application with the US FDA for questions regarding the
clinical trials design.
Importantly, the Company has completed manufacture of the drug
substance of NV-HHV-101 on kilogram-scale and of the fully
formulated drug product (skin cream) on a multi-kg scale.
These manufacturing operations were performed in its own
cGMP-capable facilities under cGMP-compliant conditions. Thus the
Company now has demonstrated expertise in the cGMP manufacture of
complex nanomedicines drugs, right from simple starting materials
to formulated drug products.
The Company believes that enabling cGMP manufacture at large
scale de-risks all of its drug programs to a substantial degree in
terms of manufacturing risk. cGMP Manufacture of nanomedicines is
known to be complex. Additionally, the Company expects to reduce
the costs of its drug programs substantially because of being able
to manufacture the drug products for human clinical trials.
The Company has repeatedly demonstrated in a human skin organ
culture model of VZV infection that NV-HHV-101 and several related
candidates were highly effective against VZV infection in this ex
vivo model of the VZV viral infection. These studies are being
performed by Professor Jennifer
Moffat at the Upstate Medical Center, SUNY, Syracuse, NY. Dr. Moffat is a leading
researcher in this field and has developed this model based on
infection of human skin.
It is anticipated that the high effectiveness observed in this
model should be predictive of effectiveness in human clinical
trials.
NanoViricides is pioneering a unique platform for developing
anti-viral drugs based on the "bind-encapsulate-destroy"
principles. Viruses would not be able to escape a properly designed
nanoviricide® drug by mutations because in doing so they would lose
the ability to bind their cognate cellular receptor(s) and thus
fail to infect productively, becoming incompetent.
NanoViricides is a unique pre-clinical pharma company in that it
fully owns its own lab and cGMP-capable flexible custom
manufacturing facility where any of our drug candidates can be
produced in multi-kilogram quantities to support corresponding
IND-enabling tox package studies as well as initial human clinical
trials. This enables rapid translation of our drug candidates to
the clinic, saving years of manufacturing translation and set-up
activities, as well as saving several millions of dollars of
external costs, while ensuring requisite quality assurance, as
compared to using a contract manufacturing organization ("CMO") for
our complex nanomedicine drugs.
The Company is currently working on its broad-spectrum drug
candidates in the HerpeCide™ program against several indications.
These include three dermal topical treatment indications, namely,
skin creams for HSV-1 "cold sores", HSV-2 "genital ulcers", and
shingles rash caused by VZV. Further, the Company is also working
on developing eye drops for treatment of Herpes Keratitis (an
infection of the external eye), and intra-vitreal injection for the
treatment of vARN, in this program. The Company has also previously
demonstrated excellent results in its FluCide™ program and in its
HIVCide™ program, among others. Thus the Company has a rich and
expanding pipeline of highly effective and safe drug candidates
against a number of viral diseases. In addition, the Company's
technology has substantial capabilities and applications, and the
potential to attack as-yet-unsolved problems caused by viral
infection, and thus lead to a great health benefit to individuals
and societies. The Company has a bright future with its expanding
pipeline, as we further the research programs driving towards cures
beyond our current objectives of effective treatments.
The market size for HerpeCide programs is in several tens of
billions of dollars because neither cures nor very effective
treatments are available. Approved treatments have limited
effectiveness, demonstrating a significant unmet medical need.
There is a significant unmet medical need for the topical
treatment of shingles rash. An effective therapy for shingles has
been estimated to have a market size into several billions of
dollars, if it reduces PHN incidence. An effective therapy for
shingles rash reduction alone is estimated to have a market size of
several hundred million dollars to low billion dollars. These
market size estimates have taken into account the potential impact
of the new Shingrix® GSK vaccine and the impact of the existing
Zostavax® vaccine. Of note, the Shingrix vaccine has been found to
cause significant, debilitating, side effects in as many as 15%-20%
of the persons receiving it. Given that shingles is not a
life-threatening disease (except under certain conditions), the
uptake of such a vaccine with high incidence of adverse effects may
be limited. Additionally, Shingrix is not yet widely available.
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.
NanoViricides' platform technology and programs are based on the
TheraCour® nanomedicine technology of TheraCour Pharma, Inc.
NanoViricides holds licenses for developing drugs against several
different viruses from TheraCour, including HSV-1 and HSV-2. In
addition, the Company and TheraCour have signed a Memorandum of
Understanding of the terms of a license for VZV (shingles, chicken
pox virus), and the remaining human herpesviruses from TheraCour.
For this purpose, the Company has conducted a valuation for the
shingles and PHN indications. TheraCour is owned substantially by
the Company's President and Executive Chairman of the Board, Anil
R. Diwan, Ph.D. As of this writing, a draft of the ensuing license
agreement is being prepared by the Company's attorneys. The draft
is expected to be provided to TheraCour's attorney for further
deliberations.
Thus we have made significant and substantial progress in the
reporting quarter towards the goal of filing our first IND
application, and we continue to build on this progress.
The Company has previously stated that it will be required to
raise additional capital in the near future to fund our drug
candidates as they advance towards IND stage and into human
clinical trials, as is the case with most if not all non-revenue
innovative pharmaceutical companies.
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.