SHELTON, CONNECTICUT -- Wednesday, February 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 second 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 February 16, 2021. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465921024154/tm214592d1_10q.htm.
The Company reported that it had approximately $18.39 million of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $0.34 million, after repayment of the short term mortgage loan of $1.1 million secured by the Company's facility that the Company had obtained in December 2019 from Dr. Anil Diwan, founder and President of the Company, on December 31, 2020. As of December 31, 2020 the Company has no debt, and the Stockholder's equity was approximately $27.74 million. During the six-month period ended December 31, 2020 approximately $4.55M 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.
The Company has been developing pan-coronavirus broad-spectrum antiviral drug candidates for the treatment of infected persons with COVID-19 since the first news of the novel 2019-nCoV disease came out. The Company is successfully advancing broad-spectrum nanoviricide anti-coronavirus drug candidates towards human clinical trials.
The Company's drug candidate NV-CoV-2 is a nanoviricide® that is designed to attack coronaviruses irrespective of the variant. This is important because variants that are less sensitive to vaccines and antibodies than the original strain are already in widespread circulation in various countries. In fact the South African variant lineage B1.351 has already been found in Connecticut in a patient with no known travel history.
The Company recently reported in a press release that NV-CoV-2 had successfully completed GLP core safety pharmacology studies that are required prior to filing an IND and was found to be safe and well tolerated.
In addition, the Company has developed NV-CoV-2-R, which is a drug candidate that encapsulates (holds in its "belly") remdesivir inside the NV-CoV-2 nanomicelles. NV-CoV-2-R is thus designed to attack both (1) the virus lifecycle outside the cells, and (2) the virus lifecycle inside the cells, enabling complete control of the infection. Therefore NV-CoV-2-R is expected to be a potential cure for the virus.
The Company is preparing to submit a pre-IND application to the US FDA with safety tolerability and effectiveness data to obtain guidance regarding human clinical trials. Additionally, the Company is actively seeking opportunities to engage appropriate sites for human clinical trials. Further, the Company is engaged in the preparation of clinical trial protocols and other activities that would be necessary for submitting an IND application to the US FDA.
The need for the broad-spectrum, pan-coronavirus nanoviricide drug treatments 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 drugs and vaccines will continue to evolve and spread, replacing prior variants, especially under pressure of the use of vaccines and antibodies. The phenomenon that viruses develop variants to escape vaccines and antibodies is well known.
Of concern is the fact that a mutation that is thought to enable the virus to escape a number of current vaccines, E484K, already present in the South African variant B1.351, and the Brazilian variant P.1, has spontaneously and independently arisen sporadically within the B1.1.7 UK-Kent variant. At present, B.1.1.7 is spreading in the USA, and is projected to become the dominant variant soon. B1.351 has also been found in the USA.
The available monoclonal antibody drugs and convalescent plasma antibodies have been reported to be less effective against several variants compared to the original target strain.
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 evolutionarily distant from the target variant. This scientific fact is now well demonstrated for the COVID-19 pandemic.
It is thus evident that effective broad-spectrum anti-coronavirus drugs such as the Company's NV-CoV-2 and NV-CoV-2-R will be needed before the world can return to normal activity.
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.