SHELTON, Conn., Aug. 26, 2019 /PRNewswire/ -- NanoViricides,
Inc. (NYSE Amer.: NNVC) (the "Company"), reports that it has
filed its annual report (Form 10-K) for the financial year ending
June 30, 2019, with the Securities
and Exchange Commission (SEC) on Friday,
August 23, 2019. The report can be accessed at the SEC
website(https://www.sec.gov/Archives/edgar/data/1379006/000114420419041547/tv525970_10k.htm).
The Company reported that, as of June 30,
2019, it had cash and cash equivalent current assets balance
of approximately $2.8 Million.
In addition, the Company reported $10.2
Million in Property and Equipment (P&E) assets. The
strong P&E assets comprise the Company's fully owned
cGMP-capable manufacturing and R&D facility in Shelton, CT. The Company has no debt. In
comparison, as of June 30, 2018, we
had cash and cash equivalent balance of approximately $7.08 Million, P&E assets of approximately
$10.8 Million, and no debt. The
reduction in current cash has resulted from continuing operating
expenditures. With the strong asset position and no debt, the
Company continues to have a strong fiscal position as it is
advancing its drugs towards human clinical trials.
The Company has performed production of its first drug product
for IND-enabling Safety/Toxicology studies in multi-kilogram scale
at our Shelton facility, resulting
in cost savings for our first drug program estimated at a few
million dollars. The Company intends to perform the Phase I and
Phase II cGMP drug production for anticipated human clinical trials
at this facility. Having our own cGMP-capable manufacturing
facility is expected to continue to enable several millions of
dollars in cost savings for our drug development pipeline and
programs.
Research and development expenses for the year ended
June 30, 2019 were about $5.92 Million, approximately similar to the prior
year ending June 30, 2018, adjusted
to about $5.91 Million. General and
administrative expenses (G&A) were at about $2.7 Million, compared to $3.4 Million in the prior year. The decrease in
G&A is primarily due to reduction in executive payroll, legal,
professional, and consulting costs.
For the year ended June 30, 2019,
the Company had a net loss of about $8.42
Million, or a basic loss per share of $0.12 compared to a net loss of about
$8.56 Million, or a basic loss per
share of $0.13 for the year ended
June 30, 2018.
During the financial year, the Company has taken steps to
strengthen its management team and its board to substantially
expand pharmaceutical industry expertise. Mr. James Sapirstein joined the Board and its
Committees as an independent director on November 1, 2018, and the Company regained full
compliance with NYSE requirements. Mr. Sapirstein is a well-known
Pharma Industry veteran, with 35+ years of Pharma experience,
having been part of almost two dozen product launches, and serving
on several board positions. Dr. Mark
Day was appointed as an independent director to the
Company's Board of Directors and its Committees, effective
June 6, 2019. Dr. Day has over 16
years of experience in the pharmaceutical industry with expertise
in opportunity due diligence and in-licensing at big pharma as well
as out-licensing from biotech. Subsequent to the reporting period,
Dr. Mukund Kulkarni resigned from
the Board for personal reasons, as of July
31, 2019. With these re-structuring events, the Company now
has significant pharmaceutical industry expertise in its Board
members and consultants.
The Company has continued its focus on taking its first drug
candidate into human clinical trials at the earliest possible date.
The Company declared a clinical candidate for the treatment of
Shingles rash, namely, NV-HHV-101, and began IND-enabling
Safety/Toxicology and other required studies in December, 2018.
Shingles is caused by the reactivation of the chickenpox virus,
i.e. VZV, in adults. The first non-GLP portion of these studies was
successfully completed around February, 2019. The drug was well
tolerated even at the highest dosages applied. There were no
adverse observations. Thereupon NV-HHV-101 progressed to the formal
GLP portion of the Safety/Toxicology studies which began around
May, 2019. The Company and TheraCour Pharma, Inc. have agreed upon
the general terms of a license agreement for VZV, and have
exchanged drafts of a definitive licensing agreement to be
perfected.
The Company reported that NV-HHV-101 has been found to be safe
and well tolerated at all dosage levels in the clinical observation
portion of the GLP Safety/Toxicology study of NV-HHV-101 as a
dermal treatment, on August 5, 2019,
subsequent to the reporting period. The in-life stage of the first
part of the GLP Safety/Toxicology studies is complete. The Company
is waiting on the full histology studies to assess the effects on
all primary organs. Both the non-GLP and GLP Safety/Toxicology
studies are conducted by BASi, Evansville, IN, a Contract Research
Organization that is specialized in IND-enabling safety/toxicology
studies.
Thus, our first drug candidate, NV-HHV-101, is on track moving
towards human clinical trials. Additional required studies for
filing an IND are also in progress.
The Company anticipates advancing NV-HHV-101 into human clinical
trials for topical dermal treatment of the shingles rash as the
initial indication, assuming that these IND-enabling studies are
successful. To this end, the Company requested a pre-IND meeting
with the US FDA and the Agency has generally agreed in its pre-IND
response in May 2019 that the plan of
drug development presented by the Company to the FDA is generally
adequate at this time. The Company will need additional funds to
file the IND application and perform human clinical trials.
The Company also continues to evaluate this broad-spectrum drug
candidate as well as certain variations based on the same
candidate, for the treatment of other herpesviruses, namely HSV-1
cold sores and HSV-2 genital herpes.
The market size for our immediate target drugs in the HerpeCide™
program is variously estimated into billions to tens of billions of
dollars. The Company believes that its dermal topical cream for the
treatment of shingles rash will be its first drug heading into
clinical trials. The Company believes that additional topical
treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold
sores" treatment, and HSV-2 "genital ulcers" treatment are expected
to follow the shingles candidate into IND-enabling development and
then into human clinical trials.
The Company's drug development business model was formed in
May 2005 with a license to the
patents and intellectual property held by TheraCour that enabled
creation of drugs engineered specifically to combat viral diseases
in humans. This exclusive license from TheraCour serves as a
foundation for our intellectual property. The Company has a
worldwide exclusive license to this technology for several drugs
with specific targeting mechanisms for the treatment of a number of
human viral diseases including HSV-1 and HSV-2. Additionally, the
Company and TheraCour have signed a Memorandum of Understanding
governing the general terms of a license for VZV drug development
in February 2019. A definitive
agreement is currently being negotiated between the parties.
The Company intends to perform the regulatory filings and own
all the regulatory licenses for the drug candidates it is currently
developing. The Company will develop these drugs in part via
subcontracts to TheraCour, the exclusive source for these
nanomaterials.
The Company has achieved several important milestones in this
year. In brief, these include the declaration of a final clinical
candidate for its lead drug indication, achieving successful
cGMP-like production of the drug as required for the
Safety/Toxicology ("Tox Package") studies, initiation and
completion of the Tox Package studies, and a Pre-IND meeting with
the FDA. In addition, the Company has initiated cGMP clinical drug
manufacture for human clinical trials of NV-HHV-101. We have
advanced the drug candidate as rapidly as possible, given resource
constraints and our dependence on external parties for the
performance and completion of various studies.
The Company believes it is on course to file its first IND and
initiate human clinical trials in the ensuing year, towards
establishing human proof-of-concept for the nanoviricides platform.
The Company intends to raise the additional funds needed for these
objectives through equity or debt financings. Our objectives for
the ensuing year include: Finalizing human clinical trials designs;
Engaging a Clinical CRO; Completion of the IND-enabling
studies; Preparation of various required reports and Filing of an
IND; cGMP Production of required clinical quantity of the drug;
Submission of an IND-application to the US FDA, or an appropriate
international regulatory agency; and Initiation and Performance of
Phase I human clinical trials, to determine safety and tolerability
of NV-HHV-101 in human subjects.
Assuming successful completion of Phase I human clinical trials,
we intend to initiate Phase II human clinical trials to determine
effectiveness of NV-HHV-101 in controlling shingles rash and to
study the effectiveness of NV-HHV-101 regarding shingles pain.
In general, as a pharmaceutical company achieves these
milestones, its risk-profile with investors improves as reflected
in the market capitalization. Management believes that as the
Company achieves these milestones, it could significantly improve
the Company's ability to raise funds in the public markets.
However, there can be no assurance that the Company will achieve
any of these milestones or that such achievements will reflect
favorably in the share price and market cap metrics. Management is
actively exploring additional required funding for its planned
objectives through debt or equity financing. There is no assurance
that the Company will be successful in obtaining sufficient
financing on terms acceptable to the Company to fund continuing
operations.
About the Company
NanoViricides, Inc. is a global leader in the application of
nanomedicine technologies to the complex issues of treatments for
viral diseases. 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.
Our anti-viral therapeutics, that we refer to as
"nanoviricides®" are designed to mimic and look to the virus like
the native host cell surface to which it binds. Since these binding
sites for a given virus do not change despite mutations and other
changes in the virus, we believe that our drugs will be
broad-spectrum, i.e. effective against most if not all strains,
types, or subtypes, of a given virus, provided the virus- binding
portion of the nanoviricide is engineered appropriately.
The Company's most advanced pre-clinical drug candidate is our
anti-VZV nanoviricide for the topical treatment of shingles, being
developed as a skin cream. In cell culture studies, it was as much
as five times more effective than acyclovir, the current standard
of care. Our anti-VZV drug candidates have also shown strong
effectiveness in studies involving VZV infection of human skin
patch organ culture ex vivo model. These studies were conducted by
Professor Jennifer Moffat at the
SUNY Upstate Medical Center in
Syracuse, NY, an internationally
recognized expert on varicella-zoster virus (VZV) infection,
pathogenesis, and anti-viral agent discovery. Some of the early
work was presented at the 31st International Conference on
Antiviral Research held June 11 - June 15,
2018 in Porto,
Portugal.
Our Shelton, CT facility
contains a multi-kilogram scale c-GMP-capable manufacturing
facility that is capable of producing any of our nanoviricides,
whether oral, skin cream or injectables. We are manufacturing the
current clinical candidate at this facility.
We believe that our facility makes NanoViricides one of the very
few development stage pharma companies that possess fully
integrated drug development capability from design/discovery,
synthesis, characterization, scaling up for clinical drug
development, and cGMP-capable manufacturing to support initial
market entry, when licensed, for any of our nanoviricides drug
candidates.
The Company's primary focus is bringing the topical treatment
for shingles into human clinical trials, which we believe is our
most advanced drug indication. Shingles is caused by reactivation
of VZV (Varicella-Zoster Virus), which causes chickenpox in
children. We anticipate that several additional indications in the
HerpeCide™ program, including skin creams for the treatment of
"genital ulcers" (HSV- 2), and for the treatment of "cold sores"
(HSV-1") would follow the shingles candidate into clinical
development. In addition, the Company has drug candidates in
development against severe influenzas (including bird flu), HIV,
Dengue, Ebola/Marburg and other viruses at different preclinical
stages. The Company will require additional funding to pursue these
candidates. According to a 2014 market report prepared by Jain
PharmaBiotech ("Jain"), entitled "Antiviral Therapeutics,
Technologies, Markets & Companies," the overall market size for
our potential drugs is estimated to be between $40~65 Billion by
2023. This broad pipeline is enabled by our unique
post-immunotherapeutic "bind-encapsulate-destroy" technology
platform.
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, shingles and chickenpox, 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 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. (FDA
refers to US Food and Drug Administration. EMA refers to the
European Union's office of European Medicines Agency.)
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SOURCE NanoViricides, Inc.