SHELTON, CT / ACCESSWIRE / May 17, 2022 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, has filed the quarterly report for third quarter of its 2022 fiscal year with the Securities and Exchange Commission. This press release should be read in conjunction with the Company's Form 10-Q filed yesterday, May 16, 2022. The submission can be viewed at the SEC website at: https://www.sec.gov/ix?doc=/Archives/edgar/data/0001379006/000141057822001688/nnvc-20220331x10q.htm .
The Company reported that it had approximately $16 million of current assets (cash, cash equivalents, and prepaid expenses) and current cash liabilities of approximately $0.4 million, as of March 31, 2022, and the stockholder's equity was approximately $24.75 million. During the nine-month period ended March 31, 2022, approximately $4.5 million in net cash was used toward operating activities. The Company had no revenues. The Company has no debt (All figures are unaudited).
The Company believes it has sufficient funds for initial human clinical trials of NV-CoV-2, its lead coronavirus drug candidate expected to enter human clinical trials soon.
The Company is pursuing a clinical trial application for its lead drug candidate for the treatment of COVID-19, NV-CoV-2. This drug candidate is designed to act by a novel mechanism of action, that we call "Re-infection Blocker".
NV-CoV-2 was found to be a broad-spectrum, pan-coronavirus drug candidate in pre-clinical studies. Escape of virus due to variants is expected to be highly unlikely because of this broad-spectrum antiviral activity of NV-CoV-2. NV-CoV-2 was also found to be significantly more effective than remdesivir in animal studies of lethal direct lung coronavirus infection that simulates the SARS-CoV-2 disease. Remdesivir is the only fully-approved drug for the treatment of SARS-CoV-2 (COVID-19) at present.
NV-CoV-2 has been found to be extremely safe and non-mutagenic in GLP and Non-GLP Safety/Toxicology studies.
The Company has developed Oral Syrup and "Oral Gummies" formulations of NV-CoV-2 for oral administration. The Company has begun cGMP-compliant manufacturing operations for the production of a large batch of the drug substance and the drug products NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies for upcoming anticipated human clinical trials for COVID-19. Clinical trial protocol for evaluation of safety and preliminary evaluation of efficacy upon oral administration of NV-CoV-2 has been defined and agreed with certain consultants already. The Company reports that it is now in the final stages of preparing the documents for submission of a clinical trial application.
Oral gummies are expected to be more readily acceptable to children and older patients because of slow dissolution in the mouth and palatability, than oral pills that may be difficult to swallow. NV-CoV-2 has demonstrated good oral bioavailability in animal studies. The Company believes that an effective oral drug to treat COVID-19 remains an unmet medical need given the limitations of available oral drugs.
The Company has also developed NV-CoV-2 formulations for injection, infusion and direct lung inhalation using a simple mouthpiece. The inhalation drug formulation is expected to benefit severely ill patients as it enables delivering much higher levels of drug (than infusion or oral dosing) directly to the lung tissue thereby helping to minimize the lung viral load and lung damage, which is expected to lead to rapid recovery of hospitalized patients.
It has become clear with the advent of the Omicron sub-variant BA.2.12.1 and other sub-variants that the pandemic is not yet over. With the evolution of variants, vaccine efficacy has decreased significantly, even with booster shots, as the Company had predicted. When the pandemic recedes, it is widely expected that SARS-CoV-2 will become endemic, as we had predicted at the very beginning of the pandemic. The limitations of vaccines and booster shots in combatting a viral pandemic have become abundantly clear through the course of the last two years. The fact that viruses escape vaccines and antibody drugs has also become amply evident.
Highly effective antivirals such as NV-CoV-2 are desperately needed for the world to return to normalcy, as evidenced by the significant interest in antiviral drugs such as remdesivir (Gilead), molnupiravir (Merck), Paxlovid (Pfizer), and a few others in development.
In addition to NV-CoV-2, the Company is 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 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.
The Company also recently disclosed that it has begun work on developing an antiviral drug against human Adenovirus-41, Type F (hAd41-F), which is widely believed to be the cause of the growing number of hepatitis cases in children worldwide that have required liver transplants and have reported fatalities. It is thought that a combination of prior SARS-CoV-2 exposure or infection, along with a hAd41-F infection may be responsible for this devastating syndrome, although no definitive cause of this hepatitis syndrome has been established. (https://www.nbcnews.com/health/health-news/symptoms-possible-causes-mysterious-child-hepatitis-cases-rcna28788 . See also, https://www.cnn.com/2022/05/06/health/hepatitis-kids-cdc-update/index.html ).
The Company has begun development of an antiviral assay for h-Ad41F in its own BSL2 laboratory. The Company plans to first screen its novel nanoviricides that have been effective against different viruses, including adenoviruses. The Company has previously developed a highly effective drug candidate demonstrated in animal studies against adenoviral Epidemic Kerato-Conjunctivitis, which is in its pipeline towards clinical development. While adenoviruses are non-enveloped, the Company's success in developing a highly effective anti-adenovirus nanoviricide is believed to be because of an attack by the nanoviricide on the adenovirus particle uprooting its fibers that are needed for attachment to human cell, and possibly disrupting the viral capsid integrity by hydrophobic interactions of the nanoviricide's lipid chains with the capsid penton and hexon protein structures. The Company will remain focused on NV-CoV-2 clinical development as the first priority while it screens for nanoviricides attacking hAd41-F.
NanoViricides is one of a few biopharma companies that has 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 previously completed IND-enabling studies for its drug candidate NV-HHV-101 for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). The Company plans on further developing the shingles drug candidate into human clinical trials after clinical trials of our COVID-19 drug candidate. The Company has additional drugs in its pipeline at various pre-clinical stages that it plans to develop towards regulatory approvals after the COVID-19 and Shingles drug clinical trials.
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.
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SOURCE: NanoViricides, Inc.