SHELTON, CONNECTICUT -- Tuesday, November 15, 2022 -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal first quarter ending September 30, 2022 with the Securities and Exchange Commission (SEC) on Monday, November 14, 2022. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057822003398/nnvc-20220930x10q.htm ).
We reported that, as of September 30, 2022, we had cash and cash equivalent current assets balance of approximately $13.1 Million. In addition, we reported approximately $14.7 Million in Property and Equipment (P&E) assets (before depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.51 Million. In comparison, as of June 30, 2022, we had cash and cash equivalent balance of approximately $14.4 Million, P&E assets of approximately $14.7 Million (before depreciation), and total current liabilities of approximately $0.41 Million. The net cash utilized in this quarter was approximately $1.03 Million. The cash expenditure is expected to increase once clinical trials begin for NV-CoV-2, our lead drug candidate to treat SARS-CoV-2 infection that causes COVID-19.
We estimate that we have sufficient funds to complete initial human clinical trials for our lead drug candidate NV-CoV-2 for the treatment of SARS-CoV-2 infection that causes the COVID-19 disease and also "long COVID".
In the reported quarter, we believe we have substantially completed preparation of certain parts of an Investigational New Drug (IND) application for filing with the US FDA. We believe that the remaining parts, involving clinical trial protocols and clinical trial organization related information, will be completed after we engage a clinical trials research organization (CRO) to conduct the trials. Thereafter we will assemble the IND package and file as appropriate. Previously, we have compiled the document called "Investigator's Brochure" pertaining to NV-CoV-2 that summarizes the developments and a potential clinical path for further discussion with a Clinical Research Organization (CRO).
We are diligently working on engaging a Clinical Research Organization (CRO) for completing the proposed clinical trials information section of the IND, and for executing the human clinical trials.
We believe that NV-CoV-2 addresses the unmet need for a safe and effective treatment that can be used in otherwise healthy patients as well as in children, based on its strong safety and effectiveness observed in animal studies. The currently available antivirals have limited applicability and effectiveness. Molnupiravir (Merck/Ridgeback) is severely restricted due to its mutagenicity and poor efficacy and unfavorable risk vs. benefit profile. Paxlovid (Pfizer) was found to be not effective in patients below 65 years of age and without co-morbidities. Remdesivir requires infusion and is limited to use in hospitalized patients with severe disease.
NV-CoV-2 as oral syrup or oral gummies is expected to be useful for patients in all age ranges and patients with or without co-morbidities experiencing mild to moderate COVID-19. NV-CoV-2 Solution for Injection, Infusion, and Inhalation is designed to help severely ill hospitalized patients.
We believe escape of new variants of SARS-CoV-2 from our drug NV-CoV-2 is highly unlikely. This is because we developed NV-CoV-2 as a broad-spectrum, pan-coronavirus drug that is active not only against SARS-CoV-2, but also against other unrelated coronaviruses. We believe this is exactly the kind of drug that is needed to combat the pandemic effectively and to be able to live with the virus, as a global society, as the SARS-CoV-2 virus is moving towards an endemic phase.
We believe that NV-CoV-2 works by a novel mechanism of action; that of blocking the re-infection cycle of the viral disease. We believe that NV-CoV-2 not only binds to the virus, but fuses with the virus surface, uprooting the glycoproteins that are required for the virus to bind to the human cell (S protein, and its products S1 and S2 proteins), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of decorating the virus, generally incompletely.
Previously, the Company has completed preclinical development of its lead drug candidate for the treatment of shingles rash, namely, NV-HHV-1. The Company intends to re-engage this program with filing an IND and performing clinical trials for NV-HHV-1 regulatory approvals after our COVID-19 program.
The nanoviricide platform technology is a leading nanomedicine technology that uniquely enables attack on both (a) the virus particles outside cells and (b) the replication of virus inside cells. If both of these factors can be controlled effectively, then the resulting drug could be a cure for the viral disease. In contrast, antibodies only bind to the virus particles outside cells, and tag them for the immune system for further processing, whereas antiviral small chemical drugs affect only the replication cycle of the virus inside cells.
Additionally, in response to recent events, we initiated a limited program for development of nanoviricide drug candidates against infection by Monkeypox virus (and related other poxviruses). We also initiated a limited program for development of nanoviricide drug candidates against infection by Enterovirus D68 (EVD68), and potentially broad-spectrum drugs against enteroviruses including poliovirus (PV). EVD68 is linked to a pediatric disease called acute flaccid myelitis (AFM) that can lead to paralysis (AFP). Recently, PV has been found circulating in the USA, particularly in New York, resulting from a revertant of an attenuated PV viral strain that is used as a polio vaccine in certain countries. PV is considered an important public health threat in light of reduced rates of childhood polio vaccinations in the USA and some other developed nations.
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. We believe that our drug candidates would be difficult for a virus to escape because these binding sites for a given virus do not change despite mutations and other changes in the virus. Further, 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 nanoviricide platform is designed to additionally hold small molecule active pharmaceutical ingredients (API's) of different types in its "belly". This allows targeted delivery of the encapsulated API to infected cells, and is also expected to improve the pharmacokinetic and pharmacodynamic properties of the API, such as rapid metabolism. Rapid metabolism is known to be an effectiveness-limiting factor for many drugs, including remdesivir. Remdesivir, developed by Gilead, is a drug that interferes with the replication of the SARS-Cov-2 virus and has been approved under emergency use regulations in the USA as well as in many other countries.