SHELTON, CT / ACCESSWIRE / May 17, 2021 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the "Company"), has filed its quarterly report for its third quarter of financial year 2021 with the Securities and Exchange Commission. This press release should be read in conjunction with the Company's Form 10-Q filed on May 14, 2021. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465921066909/tm2111798d1_10q.htm.
The Company reported that it had approximately $23.23 million of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $0.87 million. As of March 31, 2021 the Company has no debt, and Stockholder's equity was approximately $31.89 million. During the nine-month period ended March 31, 2021 approximately $5.99 M in cash was used toward operating activities. The Company had no revenues. (All figures are unaudited).
The Company believes it has sufficient funds for initial human clinical trials of at least one of its drug candidates.
We are currently focused on advancing our drug candidates for treatment of patients with COVID-19 infection towards human clinical trials, in response to the current pandemic. We are working on a pre-IND application for COVID-19 treatment at present. We have previously completed IND-enabling studies for a drug candidate for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). We plan on taking the shingles drug candidate into human clinical trials after clinical trials of our COVID-19 drug candidate.
We are developing a broad-spectrum antiviral drug candidate, NV-CoV-2, where the potential for escape of virus variants is minimized by the very design of the drug for the treatment of COVID-19 infected sick persons. In contrast, vaccines are not treatments for sick persons, and must be administered to healthy individuals, and further require several weeks for the recipient's immune system to become capable of protecting against the target virus strain which still may not protect against new virus variants circulating by that time.
In addition to NV-CoV-2, we are also developing another anti-coronavirus drug candidate, NV-CoV-2-R. This drug candidate is comprised of holding remdesivir inside our polymeric drug candidate NV-CoV-2 by a process known as encapsulation. Thus NV-CoV-2-R is potentially capable of (1) direct attack on extracellular virus, to break the "re-infection cycle" by virtue of the activity of NV-CoV-2, and (2) attack on intracellular reproduction of the virus to break the "replication cycle" as has been validated for remdesivir. If both of these cycles are broken, in theory, it is expected to result in a cure of the virus infection. Remdesivir is a challenging drug, because it is rapidly converted by blood and cellular enzymes into a significantly less potent form. It is also almost insoluble in aqueous media. Encapsulation of remdesivir in NV-CoV-2 is expected to solve these problems. Encapsulation inside NV-CoV-2 is expected to protect remdesivir from the rapid bodily metabolism, thereby raising the effective drug concentration in the body, and it is also expected to make effective drug available over a longer period of time than the Gilead formulation of remdesivir.
It is important to develop NV-CoV-2 by itself as a drug because the inherent toxicity of remdesivir which can be inferred from its molecular structure may limit its usage in certain patient populations.
We have recently completed safety pharmacology studies required for filing an IND application with the US Food and Drug Administration ("FDA") of our COVID-19 drug candidate NV-CoV-2. We have received an audited report on the GLP safety/pharmacology studies from the Company's external CRO and expect to receive the remaining report(s) soon. We are also awaiting written reports of non-GLP safety/toxicology studies and non-GLP animal efficacy antiviral efficacy studies. We are also preparing a pre-IND application for submission to the US FDA for our pan-coronavirus drug candidates to obtain further guidance and plan on submitting an IND application thereafter. We are in the process of identifying and engaging clinical study sites for the Phase 1 and Phase 2 human clinical trials of these broad-spectrum coronavirus infection treatments, in the USA as well as abroad.
We have reported in press releases that both NV-CoV-2 and NV-CoV-2-R were found to be substantially superior to remdesivir in antiviral effect based on an animal model of lethal coronavivirus infection that mimics the SARS-CoV-2 lung infection disease. Compared to treatment with remdesivir, treatment with the Company's drug candidate NV-CoV-2 alone extended the lifespan by approximately four times more days. Further, treatment with the Company's other drug candidate NV-CoV-2-R extended the lifespan approximately five times longer. Remdesivir treatment alone extended the lifespan of animals by only about 2 days in this lethal infection study.
In addition, we have reported in a press release that both of these drug candidates have been found to be effective against multiple coronaviruses in cell culture.
Thus we believe that both of our COVID-19 drug candidates, NV-CoV-2 and NV-CoV-2-R, possess broad-spectrum, pan-coronavirus effectiveness and thus would be effective against all variants of SARS-CoV-2.
The need for the broad-spectrum, pan-coronavirus nanoviricide drug treatment cannot be overstated for combating the COVID-19 pandemic given the current circumstances and the present status of the pandemic. New virus variants continue to develop in the field. The variants that have advantages in terms of transmissibility, infectivity, and escape from antibodies, drugs and vaccines will continue to evolve and spread, replacing prior variants. This is already well documented.
The devastatingly severe "second wave" of the pandemic in India that is currently raging appears to have been traced to new variants, including the UK variant B.1.1.7, and novel variants found in India, namely N400K, and a so-called "double mutant" variant, B.1.617. Of these, B.1.617 appears to be taking over and appears to be both more transmissive, severe, and is likely escaping antibodies from previous infections in patients.
Several vaccines have been found to be substantially less effective in protecting against infection by the South African variant, N501Y- V.2 (also called lineage B.1.351) than the earlier variants. A mutation present in B.1.351 as well as Brazilian variant P.1 that is thought to be possibly linked to evasion from antibody drugs and vaccines, E484K, has also been reported in UK in a further differentiated mutant of the variant of concern lineage B.1.1.7. The available monoclonal antibody drugs and convalescent plasma antibodies have been reported to be less effective against several variants.
By the very nature of how they work, vaccines and antibodies tend to be highly specific to the target virus variant, and do not afford strong protection against differentiated variants that are evolutionary distant from the target variant. This scientific fact is now well demonstrated for the COVID-19 pandemic. Developing new vaccines against then known variants, a strategy that is now being attempted is again subject to new variants spreading in the field prior to any possibility of sufficient vaccination with the new vaccine boosters. The goal of herd immunity has also become elusive and now it is being thought of as unattainable even in the USA.
NanoViricides is one of a few biopharma companies that operates its own cGMP-compliant manufacturing facility. The Company intends to produce its drugs for clinical trials in this facility. The Company has the capability to produce sufficient drugs for about 1,000-5,000 patients in a single batch of production, depending upon the drug and the dosage. This production capacity is anticipated to be sufficient for first-in-human use in the current SARS-CoV-2 pandemic for our anti-coronavirus drug in development, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles.
The Company has developed NV-CoV-2 based on its platform nanoviricides® technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only two attachment points per antibody.
It is anticipated that when a virus comes in contact with the nanoviricide, not only would it land on the nanoviricide surface, binding to the copious number of ligands presented there, but it would also get entrapped because the nanomicelle polymer would turn around and fuse with the virus lipid envelope, harnessing a well known biophysical phenomenon called "lipid-lipid mixing". In a sense, a nanoviricide drug acts against viruses like a "venus-fly-trap" flower does against insects. Unlike antibodies that tag the virus and require the human immune system to take over and complete the task of dismantling the virus, a nanoviricide is a nanomachine that is designed to not only bind to the virus but also complete the task of rendering the virus particle ineffective.
In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide® technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
The Company has developed NV-CoV-2-R based on this encapsulation capability that is built in its nanoviricide NV-CoV-2. The Company has chosen to encapsulate "remdesivir" as the participating drug for blocking the viral replication cycle. Remdesivir is approved by the US FDA for the treatment of SARS-CoV-2 infection. Encapsulation of remdesivir in the Company's nanoviricide envelope is expected to protect it from metabolism in the body. This protection can be expected to lead to significant enhancement in the effectiveness of remdesivir itself (in the encapsulated form), by potentially increasing both the effective remdesivir concentration and its duration of action. This could be an additional favorable effect for the Company's anti-coronavirus drug candidate NV-CoV-2-R. Remdesivir is sponsored by Gilead. The Company is developing its drug candidates independently at present.
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 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.
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.
