Full Press Release Details
NanoViricides Completes Licensing for Coronavirus
Field which Includes Current COVID-19 Drug Development
Shelton, Connecticut - September 14, 2019 -- NanoViricides, Inc.
(NYSE Amer.: NNVC) (the "Company"), a global leader in nanomedicines against viruses, announced today that it has completed
the process of licensing the human Coronavirus field for drug development and commercialization from TheraCour Pharma, Inc. ("TheraCour").
The Company executed a license agreement for the field comprising anti-viral treatments for coronavirus derived human infections with
TheraCour Pharma, Inc. on September 8, 2021 (the "Agreement").
The licensed field includes antiviral drugs to treat SARS-CoV-2 and
its variants that cause the COVID-19 disease resulting in a global pandemic that continues to rage through the world, wave after wave,
as new variants develop and take hold. There was no upfront cash payment for the license and the compensation terms were generally consistent
with prior licenses, and are summarized further below.
NanoViricides is currently working on taking its two COVID-19 lead
drug candidates, namely, NV-CoV-2- and NV-CoV-2-R, into human clinical trials. The Company believes that the essential preclinical work
is substantially complete for taking these drugs into human evaluation.
The Company believes that these broad-spectrum anti-coronavirus drugs
will continue to be effective even as the virus continues to mutate developing into a number of variants of concern. Antibody protection
afforded by vaccines and the effectiveness of antibody drugs have continued to decline progressively as new SRAS-CoV-2 variants have emerged.
The Company believes that its unique anti-viral nanomachine technology overcomes these issues.
The Company believes it is well poised to deliver an out-patient oral
medicine to treat COVID-19 infections. The Company has found that its anti-COVID-19 drugs exhibited strong antiviral effectiveness when
given orally in animal studies.
The Company also believes that its COVID-19 drugs will be suitable
for use in pediatric patients, and we plan to include pediatric cohorts into clinical trials at the appropriate stages. We believe that
pediatric use of these drugs is feasible based on the excellent safety profile we have observed in animal studies. As the variants evolve,
pediatric infections and their severity have begun to rise, causing major worldwide concerns even as the world is trying to move towards
normalcy in education and child social interactions.
The Company's anti-COVID drugs are based on polymeric micelle
nanomedicine technologies developed by TheraCour Pharma, Inc. and its affiliate, AllExcel, Inc. The inventors have filed a PCT
patent application that forms the basis of the Company's two lead drug candidates, namely, NV-CoV-2 and NV-CoV-2-R. The new patent
application covers the new technologies, compositions, formulations, processes, manufactured products, and methods of use, among other
specifics. This patent application was filed on June 25, 2021, application number PCT/US2007/001607, entitled "Self-Assembling
Amphiphilic Polymers As Anti-Covid-19 Agents". Its nominal expiry date would be 20 years, after filing and if issued, i.e. June 24,
2041, and could be extended in certain countries under regulatory extensions to as late as into the year 2043, providing a significant
Under the Agreement, NanoViricides has obtained a world-wide, exclusive,
sub-licensable, license to use, promote, offer for sale, import, export, sell and distribute antiviral drugs that treat human Coronavirus
infections using TheraCour's proprietary as well as patented technology and intellectual property, including the new patent application
cited above. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well
as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the
parties, with no duplication of costs allowed.
NanoViricides will not make any upfront cash payments to TheraCour
and has agreed to the following milestone payments to TheraCour: 100,000 shares of the Company's Series A Convertible Preferred
Stock, par value $0.001 per share (the "Series A Preferred Stock") upon the execution of the Agreement; 50,000 shares
of Series A Preferred Stock after the grant of the approval of Licensee's Investigational New Drug (IND) Application, or its
equivalent; cash payments of $1,500,000 after the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion
of Phase 1 Clinical Trials or its equivalent for at least one product within twelve (12) months from the date of the acceptance of the
IND; $2,500,000 no later than six (6) months after the completion of Phase 2A Clinical Trials or its equivalent for at least one
product within twenty (24) months from the date of the completion of Phase 1 or its equivalent; 100,000 shares of Series A Preferred
Stock after the initiation of Phase 3 clinical trials or its equivalent; and, at TheraCour's option, $5,000,000 in cash or 500,000
shares of Series A Preferred Stock, no later than six (6) months after the completion of Phase 3 Clinical Trials or its equivalent
for at least one product within thirty-six (36) months from the completion of Phase 2 Clinical Trials or its equivalent. In addition,
the Company agreed to pay to TheraCour fifteen percent (15%) of net sales of licensed products and any income from sublicensed products,
consistent with previous agreements. Under the Agreement, TheraCour retains the exclusive right to develop and manufacture the Licensed
Products. The Agreement contemplates that the parties will enter into a separate Manufacturing and Supply Agreement for the commercial
manufacture and supply of the drug products if and when NanoViricides intends to engage into commercialization of the drugs. The Agreement
provides that the Manufacturing and Supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market
rate based on then-current industry standards, and include customary backup manufacturing rights, as with prior agreements.
To assist in the analysis of the terms of the Agreement, NanoViricides
commissioned research reports on Coronavirus drug market sizes for the Coronavirus antivirals field from an independent consulting agency,
Nanotech Plus, LLC. Additionally, the Company obtained business analysis and valuation reports for potential licensing terms for a coronavirus
drug from an independent consultant. NanoViricides was represented by McCarter & English, LLP while TheraCour was represented
The Series A Convertible Preferred Shares are only convertible
upon a "change of control" of the Company as defined in its full specification, are non-transferrable and have no trading
market. Each Series A share carries 9 votes, and is convertible only upon a change of control into 3.5 shares of the Company's
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 coronaviruses, herpesviruses, VZV, HIV, Influenza, and others.
* PCT = Patent Cooperation Treaty. Enables global intellectual property
NanoViricides, Inc. (the "Company")(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. We are developing clinical
candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its
first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs
in various pre-clinical stages.
The Company is now working on tasks for completing
an IND application for its COVID-19 drug candidates. The Company cannot project an exact date for filing an IND for this drug because
of its dependence on a number of external collaborators and consultants. The Company is currently pursuing two separate drug candidates
for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is
our other drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it. The Company believes that since remdesivir is
already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir
is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company intends to re-engage into an IND
application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials,
based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization
for COVID-19 drug development work.
The Company is also 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. NanoViricides' platform
technology and programs are based on the TheraCour nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel.
NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in
perpetuity for the treatment of the following human viral diseases: human Coronavirus infections, Human Immunodeficiency Virus (HIV/AIDS),
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza
and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company's
technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc.
The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific
viruses, as established at its foundation in 2005.
As is customary, the Company must state the
risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital.
As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical