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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: www.sec.gov/ix?doc=/Archives/edgar/data/...c-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. (www.nbcnews.com/health/health-news/...patitis-cases-rcna28788 . See also, www.cnn.com/2022/05/06/health/...s-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.
