SHELTON, US - EQS Newswire - June 30, 2020 - NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that it has been added to the Russell Microcap(R) Index effective after the U.S. markets opened yesterday, Monday, June 29, 2020.
Anil R. Diwan, PhD, President and Executive Chairman of the Company, commented, "We believe inclusion in the Russell Microcap index is a consequence of the significant progress we have made recently in advancing our novel portfolio of special purpose nanomaterials for antiviral therapy towards our first IND filing. As we approach several important milestones in the coming months, we welcome the heightened visibility that is expected to result from inclusion in this widely followed benchmark."
Membership in the Russell Microcap(R) Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. Inclusion of NanoViricides in the Russell Microcap Index may be expected to increased participation in the NNVC stock positions of investment managers and institutional investors that purchase, follow or employ this index.
For more information on the Russell Microcap(R) Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
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(R) drug by mutations because in doing so, it is expected that, they would lose the ability to bind their cognate cellular receptor(s) and thus fail to infect productively, becoming incompetent.
NanoViricides possesses its own cGMP-capable manufacturing capability where thousands of doses of its drugs can be manufactured rapidly. More specifically, the Company has the capability to produce multiple kilograms of the active pharmaceutical ingredient (API) per batch.
The Company is developing a therapy or drug to combat the SARS-CoV-2 virus that has caused the COVID-19 pandemic. It is anticipated that this drug that is designed to directly attack the virus, would lead to successful treatment of infected patients. It is not a drug that is designed for reducing clinical symptoms alone. The drug we are developing is not a vaccine, and does not have to be given to everyone, but will need to be given only to patients, if we can develop it successfully.
The Company has reported successful results for its broad-spectrum anti-coronavirus drug candidates in cell culture studies against multiple coronaviruses as well as in animal studies against a coronavirus called hCoV-NL63 that binds to the same human receptor as SARS-CoV-2, namely ACE2, and causes similar pathology. The Company is advancing this program towards a pre-IND application to the US FDA with the aim of progressing it further towards human clinical trials as rapidly as possible.
The Company continues to advance its first drug candidate, namely NV-HHV-101 skin cream, for the treatment of shingles rash as its first indication, towards human clinical trials. The Company is now in the process of writing and completing its IND ("Investigational New Drug") application for NV-HHV-101 to the US FDA, which includes protocols for human clinical studies, with the help of its several regulatory consultants. The Company is in the process of identifying and selecting appropriate partners and collaborators for the intended Phase1/2a human clinical studies for this drug candidate.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide(R) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is in the process of completing an IND application to the US FDA for this drug candidate. The Company cannot project an exact date for filing an IND because of its dependence on a number of external collaborators and consultants, and the effects of recent COVID-19 restrictions.
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(R) 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 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 has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. 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.
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. IND application refers to "Investigational New Drug" application. CMC refers to "Chemistry, Manufacture, and Controls".