SHELTON, CT / ACCESSWIRE / November 17, 2020 / 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 first 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 November 16, 2020. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465920125844/tm2034254d1_10q.htm.
The Company reported that it had approximately $22.0 Million (M) of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $0.76M excluding a mortgage of $1.1M, as of September 30, 2020, the end of the reporting period. The net cash used in operating activities during the three months period was approximately $2.24M. The Company's expenditures were in line with budget estimates. Shareholder equity stood at approximately $29.98M for the quarter (unaudited figures). The Company had no revenues. The Company has no long-term debt. Due to its strong cash position, the Company intends to pay off the mortgage note in full at its original maturity date in December 2020. The Company has no long-term debt.
The Company has previously reported that, on July 8, 2020 the Company entered into an underwriting agreement (the "Underwriting Agreement") with Kingswood Capital Markets, a Division of Benchmark Investments, Inc. ("Kingswood"). The offering was consummated on July 10, 2020, whereby the Company sold 1,369,863 shares of common stock and a fully exercised Underwriters' over-allotment option of 205,479 additional shares at the public offering price of $7.30 per share. No warrants were issued in this offering. The net proceeds to the Company from the offering was approximately $10.4 million after deducting underwriting discounts and commissions and other estimated offering expenses, bolstering its cash position.
The Company believes it has sufficient cash in hand to fund continuing operations for more than two years at current expenditure rate. However, the Company anticipates that its expenditures would increase as its lead drug programs move into human clinical trials phase. The Company believes it has sufficient funds for initial human clinical trials of at least one of its drug candidates.
The Company's drug program for the treatment of SARS-CoV-2 infection that causes the COVID-19 spectrum of diseases is moving satisfactorily towards completion of IND-enabling studies. The Company announced on November 11, 2020 that it has engaged Calvert Labs, a contract research organization ("CRO") to perform the GLP "Core Safety/Toxicology Studies" for its Coronavirus drug candidate as required for an IND filing. These Core Safety/ Pharmacology studies have already begun, and are expected to be completed soon. The Company intends to file an IND application for this drug candidate with the US FDA, assuming these safety/toxicology studies are successful. Prior to filing an IND, the Company is currently drafting a pre-IND application for this drug candidate to submit to the US FDA for seeking guidance towards clinical trials. The Company is in the process of designing human clinical trials and arranging for conducting the same in an expeditious manner.
The Company believes that its current anti-coronavirus drug candidate is likely to be a cure for the SARS-CoV-2 infection. This belief is based on the design of the drug candidate. The nanoviricide part of this drug candidate by itself is expected to attack the extra-cellular virus, thereby blocking the virus re-infection cycle. In addition, this nanoviricide encapsulates another drug substance that is known to block the intracellular replication cycle of the virus. If both of these cycles are blocked effectively, the complete drug can be expected to result in a cure of the SARS-CoV-2 viral infection.
The Company develops its class of drugs, that we call nanoviricides®, using a platform 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 a maximum of 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 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 (due to 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. 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 have declared a clinical development candidate, namely NV-CoV-1-R, which encapsulates remdesivir inside NV-CoV-1, for the treatment of COVID-19. The Company cannot project an exact date for filing an IND for NV-CoV-1-R because of its dependence on a number of external collaborators and consultants.
The Company is now working on performing required safety pharmacology studies and completing an IND application for NV-CoV-1-R. The Company believes that since remdesivir already is an FDA-approved drug for the treatment of SARS-CoV-2, NV-CoV-1-R is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed NV-CoV-1-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.
Forward Looking Statements
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. CMC refers to "Chemistry, Manufacture, and Controls".
