SHELTON, CT/ACCESSWIRE/ February 15, 2023 / NanoViricides, Inc. (NYSE American: NNVC) (the “Company”) reports that it filed its Quarterly Report on Form 10-Q for the first fiscal quarter ended December 31, 2022 with the Securities and Exchange Commission (SEC) on Tuesday, February 14, 2023. The report is located on the SEC’s online page (https://www. sec. gov/ix?doc=/Archives/edgar/data/1379006/000141057823000129/nnvc-20221231x10q. htm).
We reported that as of December 31, 2022, we had a balance of existing monetary assets and money equivalents of approximately $11. 5 million. In addition, we reported approximately $8. 4 million in assets and appliances (P)
We know we have enough budget to complete the first human clinical trials of our leading drug candidate NV-CoV-2 for the treatment of SARS-CoV-2 infection that causes COVID-19 disease and also “long COVID. “
During the reported quarter, we compiled and finalized the medical literature to expand an IND application to the U. S. FDA. The U. S. Department of Health and Human Clinical Trials of NV-CoV-2 in COVID-19 Patients is being used. We also compiled and produced medical literature that would be needed for foreign clinical trial programs under ICH and regulatory guidance in some countries.
As a result, a clinical trial application for the evaluation of oral management of NV-CoV-2, along with maximum related agreements, has been finalized for one of our projects outside the United States. We plan to announce the resulting collaborations once the formal milestones are completed.
In addition, significantly, we have started clinical production of the drug NV-387.
Our existing production scale of five kg of API is expected to be sufficient to treat approximately 1000 patients, the actual dose required for efficacy is only established in clinical trials.
We have developed 3 distinct pharmaceutical formulations of NV-387 for the remedy of COVID-19 patients: (i) NV-CoV-2 Oral Gummies, a fixed-dose form for use in mild to moderate outpatient therapy; (ii) oral syrup of NV-CoV-2, the dosage amount of which can be adjusted, as needed in pediatric patients (based on frame weight); and (iii) NV-CoV-2 (sterile) solution for injection, infusion and inhalation.
During the reported quarter, we were successful in the design and external production of traditional filling, packaging and sealing apparatus for oral syrup and chewing gum formulas in clinical batches. We plan to have NV-CoV-2 injectable formulas manufactured and packaged in an external manufacturer contract.
Thus, NanoViricides is temporarily one of the few small pharmaceutical corporations that is completely “vertically integrated” (“vertically integrated” means having functions ranging from R
We believe NV-CoV-2 addresses the unmet need for a safe and effective remedy that can be used differently in healthy patients and in children, based on its maximum protection and efficacy seen in animal studies. Currently available Antivirals have limited applicability and efficacy. Molnupiravir (Merck/Ridgeback) is severely limited due to mutagenicity, low efficacy and the threat profile of adverse advantages. Paxlovid (Pfizer) has been shown to be useless in patients younger than 65 years of age and without comorbidities. Remdesivir requires infusion and is limited to use in hospitalized patients with severe disease.
NV-CoV-2 in the form of oral syrup or oral gums for patients of all ages and equipment with or without mild to moderate COVID-19 comorbidities. The NV-CoV-2 solution for injection, infusion and inhalation is designed for the care of critically ill hospitalized patients.
We believe that the leakage of new SARS-CoV-2 variants from our drug NV-CoV-2 is highly unlikely. In fact, we developed NV-CoV-2 as a broad-spectrum pan-coronavirus drug that is active not only opposite to SARS-CoV-2, but also opposite to other unrelated coronaviruses. We believe that this is precisely the type of medicine that is needed to combat the pandemic well and to be able to live with the virus, as a global society, such as SARS- The CoV-2 virus is advancing towards an endemic phase.
We that NV-CoV-2 operates according to a new mechanism of action; that of blocking the cycle of reinfection of the viral disease. We know that NV-CoV-2 not only binds to the virus, but fuses with the surface of the virus, tearing off the necessary glycoproteins through the virus to bind to the human mobile (protein S and its protein products S1 and S2), so the virus cannot infect a mobile. In contrast, antibodies can only personalize the virus, usually incompletely.
Previously, the company completed the preclinical progression of its leading drug candidate for the treatment of shingles rash, NV-HHV-1. The company intends to re-engage this program in clinical trials for NV-HHV-1 regulatory approvals following our COVID-19. 19 program.
The generation of nanoviricide platforms is a cutting-edge generation in nanomedicine that uniquely enables the attack of (a) viral debris outside cells and (b) internal virus replication cells. If those two points can be controlled well, the resulting drug may only be a cure for the viral disease. In contrast, antibodies bind only to virus remnants outside the cells and mark them for the immune formula for further treatment, while small antiviral chemicals only have effects on the replication cycle of the virus’s inner cells.
The viral popularity ligand NV-387 is designed to mimic certain characteristics of heparan sulfate proteoglycans (HSPG) and similar glycosaminoglycans (GAGs). HSPGs serve as an initial binding and concentration site for a large number of viruses, and can also serve as mobile access. Sites for some viruses. Therefore, NV-387 is likely to have applicability in the treatment not only of coronavirus, but also of some other viral infections.
We have initiated the procedure of expanding the spectrum of use of the NV-387, which would especially increase the return on investment (ROI). To this end, we have recently introduced two new systems in reaction to public health threats: (a) nanoviricides to treat Poxvirus infections (the Mpox outbreak in the past known as MonkeyPox); and (b) nanoviricides to treat enterovirus infections. Enterovirus EV-D68 causes a pediatric disease called acute flaccid myelitis (AFM) that can cause paralysis (AFP) in a small number of children. Polio is also an enterovirus and has recently been detected primarily in the New York City area.
Our antiviral therapies, which we call “nanoviricides®,” are designed to mimic and resemble the virus as the local surface of the mobile host to which it binds. Binding sites for a given virus are not replaced despite mutations and other modifications of the virus. In addition, we know that our drugs will be broad-spectrum, that is, effective against most, if not all, strains, types, or subtypes of a given virus, provided that the part of the nanoviricide that binds to the virus is properly designed.
The nanoviricidal platform is designed to also involve small-molecule active pharmaceutical ingredients (APIs) of other types in its “belly. “This enables targeted delivery of encapsulated API to inflamed cells and also merits API’s pharmacokinetic and pharmacodynamic homes, such as immediate metabolism. Fast metabolism is known to be something that restricts the effectiveness of many medications, and adds remdesivir. Remdesivir, developed through 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 United States and many other countries.
About nanoviricides
NanoViricides, Inc. (the “Company”) (www. nanoviricidas. com) is a development-stage company that creates special-purpose nanomaterials for antiviral therapy. The new elegance of the Company’s nanoviricidal drug applicants is designed to target and dismantle in particular virus particles. Our main drug candidate is NV-CoV-2 for the treatment of COVID-19 disease caused by the SARS-CoV-2 coronavirus. Our other complex candidate is NV-HHV-1 for the treatment of shingles (formerly called NV-HHV-101). The company cannot wait for a precise date for the submission of an IND for one of its drugs due to the dependence on several collaborators and external consultants. 2 in Phase I/II human clinical trials.
NV-CoV-2 is our COVID-19 nanoviricide drug candidate that encapsulates remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is composed of NV-CoV-2 with remdesivir encapsulated in its polymer The company believes that since remdesivir is already approved by the U. S. FDA, it is not yet approved by the U. S. FDA. In the U. S. , our candidate drug that encapsulates remdesivir is likely to be an approved drug, if protection is comparable. Remdesivir is evolving through Gilead. La company has independently developed its own NV-CoV-2 and NV-CoV-2-R drug applicants.
The Company is also developing drugs for a number of viral diseases, including oral and genital herpes, viral eye diseases, adding CEK and herpetic keratitis, H1N1 swine flu, H5N1 bird flu, influenza infection, HIV, hepatitis C, rabies, dengue and the Ebola virus, among others. The NanoViricides platform generation and systems are based on TheraCour’s TheraCour® nanomedicine generation, licensed by TheraCour to AllExcel. NanoViricidas holds an exclusive and perpetual international license for this generation of several drugs with express 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 virus and Asian avian influenza, dengue virus, virus from Japanese encephalitis, West Nile virus, Ebola/Marburg virus, and certain Coronaviruses. The Company intends to download a license for poxvirus and/or enterovirus if the first studies are successful. The generation of the company is based on extensive exclusive and sub-licensable box licenses for drugs developed in those spaces through TheraCour Pharma, Inc. The business style of the company is based on the generation of licenses from TheraCour Pharma Inc. for sectors of fast application of fast viruses, as established. when it was founded in 2005.
As usual, the company will have to hint at the risk that the path to typical drug development for any pharmaceutical product will be incredibly long and require very large capital. Any of the company’s pharmaceutical applicants would have sufficient efficacy and protection for human clinical progression. In addition, lately there is no guarantee that the positive effects of the coronavirus in our laboratory will lead to successful clinical trials or a successful pharmaceutical product.
This press release includes forward-looking statements that reflect the Company’s existing expectations regarding long-term events. Actual occasions may also differ drapingly and substantially from those projected here and have a number of points. Certain statements contained in this release and other written or oral statements made through 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. Do not place undue reliance on forward-looking statements, as they involve known and unknown risks, uncertainties, and other matters which, in some cases, are beyond the control of the Company and which also can, and most likely will, have a shades have an effect on actual effects, activity levels, functionality, or achievement. The Company assumes no legal responsibility to publicly update or revise those forward-looking statements for any reason, or to update the reasons why actual effects may also differ slightly from those expected in those forward-looking statements, even if new data becomes be held in the long run Important items that may also cause actual effects to differ slightly from company expectations come with, but are not limited to, items disclosed in “Risk Factors” and elsewhere in the corporate filings. business from time to time with the United States. Securities and Exchange Commission and other regulatory authorities. While it is not possible to expect or identify all of those points, they may come with the following: demonstration and proof of principle in preclinical trials that a nanovirucide is safe and effective; the successful progression of our candidate products; our ability to search and download regulatory approvals, aggregating with respect to the indications we seek; the successful commercialization of our product candidates; and acceptance of the market position of our products.
FDA refers to the U. S. Food and Drug Administration. UU. La IND application refers to the application for an “investigational new drug”. cGMP refers to existing production practices. CMC refers to “Chemistry, Manufacturing and Control”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the committee of the European Medicines Agency (EMA) responsible for medicinal products for human use. API stands for “Active Pharmaceutical Ingredient”.
Contact:NanoViricides, Inc. info@nanoviricidas. com
Public Relations Contact: MJ Clyburn TraDigital IR clyburn@tradigitalir. com
SOURCE: NanoViricidas, Inc.