SHELTON, CT / ACCESSWIRE / October 14, 2022 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2022 with the Securities and Exchange Commission (SEC) on Thursday, October 13, 2022. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057822002878/nnvc-20220630x10k.htm).
We reported that, as of June 30, 2022, we had cash and cash equivalent current assets balance of approximately $14.4 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 $0.41 Million. In comparison, as of June 30, 2021, we had cash and cash equivalent balance of approximately $20.5 Million, P&E assets of approximately $14.3 Million (before depreciation), and total current liabilities of approximately $0.35 Million.
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 year, we believe we have completed the IND-enabling pre-clinical drug development tasks pertaining to NV-CoV-2. Subsequently, we have received reports of all of the studies conducted externally. 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 now working on preparation of an Investigational New Drug (IND) application for filing with the US FDA. Our part of this application including primarily (i) Chemistry, Manufacture and Controls (CMC) information and (ii) Safety/Toxicology and Anti-viral Studies is substantially ready, and is being formatted into the appropriate IND formats. In addition, we are 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. Once this information is added to the IND application, we will be able to file the IND application.
Subsequent to the reported period, we have commissioned cGMP-compliant manufacture of the Drug Product formulations of NV-CoV-2 for use in the anticipated Phase 1 / 2 human Clinical trials.
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.
In addition, as new variants have arisen a number of antibodies and antibody cocktails that have been developed and have received Emergency Use Authorizations (EUA) from the US FDA have had their EUA's revoked due to loss of effectiveness. The antibodies that continue to hold EUA are known to have significantly reduced activities against the newest Omicron variants that have begun to spread in the UK-Europe region, and are expected to reach the USA in a matter of months. We had clearly anticipated this problem of antibodies right at the beginning of the pandemic.
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. As such, we believe it is highly unlikely that the generation of new variants of SARS-CoV-2 would allow the variant to escape NV-CoV-2. 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 were pleasantly surprised with the strong anti-viral effectiveness of orally administered NV-CoV-2 in our animal studies. We have therefore developed two oral formulations of this drug, (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies. We believe that these formulations should provide highly effective treatment of SARS-CoV-2 variant infection in mild to moderate COVID-19 cases.
Additionally, we have developed (iii) NV-CoV-2 Solution for Injection, Infusion and Inhalation. We believe that infusion of NV-CoV-2 solution formulation in hospitalized cases is likely to be one of the best available treatments for COVID-19. We plan on studying injection rather than infusion, for its simplicity, and applicability to out-patient treatment (i.e. without hospitalization), which would be highly useful in the underdeveloped world populations. We believe that a combination of NV-CoV-2 given by infusion together with NV-CoV-2 given by direct lung inhalation would be a highly effective protocol for the treatment of severe lung disease caused by SARS-CoV-2. The inhalation, performed with a simple hand-held device, would deliver high concentrations of the drug directly at the sites of viral injury in lungs, enabling the strongest possible attack on the virus.
In addition to the strong effectiveness, the strong safety that we have observed in multiple animal models is suggestive that NV-CoV-2 can be used for treating children as well as adults, potentially spanning the age range potentially from infants to over 80 years old patients. If so, NV-CoV-2 would be the only oral drug with applicability to the entire human population. In contrast, remdesivir (Veklury®, Gilead) is approved only for hospitalized patients, and Paxlovid® (Pfizer) was recently found to be not effective in patients less than 65 years old patients with no existing co-morbidities.
In addition to NV-CoV-2 itself as a drug to combat COVID-19, we are also developing another SARS-CoV-2 drug candidate, NV-CoV-2-R, which encapsulates remdesivir inside NV-CoV-2. While remdesivir substantially blocks the replication of the virus inside cells, NV-CoV-2 is designed to block the virus outside cells by entrapping it and thereby not allowing it to infect the cells in the first place. Thus, NV-CoV-2-R is designed to block both the intra-cellular life cycle of the virus and the extra-cellular life cycle of the virus. Blocking both lifecycles should enable complete control of the viral disease, promising a potential cure. Remdesivir, sponsored by Gilead, is a known antiviral drug that has received full US FDA approved for treatment of COVID-19 and has received EUA in many countries. We are developing NV-CoV-2-R on our own, independently of Gilead.
We intend to develop NV-CoV-2 through Phase1/2a clinical trials first, and anticipate clinical development of NV-CoV-2-R thereafter.
NV-CoV-2 and NV-CoV-2-R were found to be highly effective against a totally lethal coronavirus lung infection in an animal model study in rats based on multiple indicators. Treatment with the standard remdesivir formulation extended lifespan by only 2 days, while treatment with NV-CoV-2 and NV-CoV-2-R extended the lifespan by 8.5 and 10.5 days respectively; an extremely significant improvement attesting to a very strong effectiveness of our drug candidates.
NV-CoV-2 was found to be effective in cell cultures against infection by several unrelated coronaviruses, including SARS-CoV-2 pseudovirions (see the Company's press release dated October 11, 2021 for details). These studies have established that both NV-CoV-2 and NV-CoV-2-R are broad-spectrum, pan-coronavirus drugs and therefore would remain effective even as variants emerge.
In animal studies, our drugs NV-CoV-2 and NV-CoV-2-R have both exceeded the effectiveness of remdesivir, which is approved for treatment of severe hospitalized cases of COVID-19, and has shown substantial clinical benefit in clinical trials in moderate to severe COVID-19 patients. If the strong effectiveness of NV-CoV-2 and NV-CoV-2-R observed in animal studies is borne out in human clinical trials, then our drugs would be substantially more effective than existing therapies.
Previously, the Company has completed pre-clinical development of its lead drug candidate for the treatment of shingles rash, namely, NV-HHV-101. The Company intends to re-engage this program with filing an IND and performing clinical trials for NV-HHV-101 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.
Research and development expenses for the year ended June 30, 2022 were approximately $5.78 Million, compared to about $6.11 Million in the prior year ending June 30, 2021. The decrease was primarily due to decreased costs of pre-clinical R&D on the COVID-19 drug candidates. General and administrative expenses (G&A) were at about $2.33 Million, compared to $2.63 Million in the prior year. The reduction in G&A was primarily due to decrease in legal, professional, and consulting costs.
For the year ended June 30, 2022, the Company had a net loss of about $8.1 Million, or a basic loss per share of $0.70 compared to a net loss of $8.82 Million, or a basic loss per share of $0.81 for the year ended June 30, 2021.
The Company's drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. 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 caused by viruses including but not limited to Coronaviruses, VZV (shingles), HSV-1 and HSV-2.
The Company intends to perform the regulatory filings and own the regulatory licenses for the drug candidates it is currently developing. The Company intends to develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials.
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.
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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. 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 now working on tasks for completing an IND application. 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. 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 candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
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. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines.
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