SHELTON, CT / ACCESSWIRE / October 13, 2021 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2021 with the Securities and Exchange Commission (SEC) on Tuesday, October 12, 2021. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/0001379006/000110465921125343/tm2124471d1_10k.htm).
We reported that, as of June 30, 2021, we had cash and cash equivalent current assets balance of approximately $20.8 Million. In addition, we reported $9.08 Million in Property and Equipment (P&E) assets. The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were less than $0.4 Million. In comparison, as of June 30, 2020, we had cash and cash equivalent balance of approximately $14 Million, P&E assets of approximately $9.54 Million, and total current liabilities of approximately $2.15 Million.
During the fiscal year ended June 30, 2021. we raised approximately $10.4 Million in net proceeds from an underwritten equity offering with Kingswood Capital Markets, a Division of Benchmark Investments, Inc. (“Kingswood”, now known as EF Hutton) on July 10, 2020. No warrants were issued in this Offering. Additionally, on March 2, 2021 we raised approximately $6.1 million in net proceeds from the sale of common stock under an At Market Issuance Sales Agreement with B. Riley Securities, Inc. that was entered into on July 31, 2020. These additional funds have significantly bolstered the Company’s finances, enabling it to advance its COVID-19 drug candidates towards human clinical trials.
We estimate that we have sufficient funds to complete initial human clinical trials for at least one of our drug candidates.
We have made significant progress in responding to the global COVID-19 pandemic. As early as May/June 2020, we had already developed potential drug candidates. Our COVID-19 drug candidates successfully entered core safety pharmacology studies required prior to commissioning human clinical trials around October/November, 2020. These studies have now been completed and we have received the GLP Safety/Toxicology reports from the external CRO in August 2021. We are now engaged in the preparation of clinical trial protocols and other activities that would be necessary for filing of an IND with the US FDA or equivalent regulatory filings for entering into human clinical trials in other countries.
In the reported year and subsequently to date, we have already completed pre-clinical IND-enabling studies on our novel SARS-CoV-2 drug candidate NV-CoV-2. In addition to NV-CoV-2 itself as a drug to combat COVID-19, we are also developing another SARS-CoV-2 drug candidate, NV-CoV-2-R, which encapsulates remdesivir inside NV-CoV-2. While remdesivir substantially blocks the replication of the virus inside cells, NV-CoV-2 is designed to block the virus outside cells by entrapping it and thereby not allowing it to infect the cells in the first place. Thus, NV-CoV-2-R is designed to block both the intra-cellular life cycle of the virus and the extra-cellular life cycle of the virus. Blocking both lifecycles should enable complete control of the viral disease, promising a potential cure. Remdesivir, sponsored by Gilead, is a known antiviral drug that has received full US FDA approved for treatment of COVID-19 and has received EUA in many countries. We are developing NV-CoV-2-R on our own, independently of Gilead.
We intend to develop NV-CoV-2 through Phase1/2a clinical trials first, and anticipate clinical development of NV-CoV-2-R thereafter.
NV-CoV-2 and NV-CoV-2-R were found to be highly effective against a totally lethal coronavirus lung infection in an animal model study in rats based on multiple indicators. Treatment with the standard remdesivir formulation extended lifespan by only 2 days, while treatment with NV-CoV-2 and NV-CoV-2-R extended the lifespan by 8.5 and 10.5 days respectively; an extremely significant improvement attesting to a very strong effectiveness of our drug candidates.
NV-CoV-2 was found to be effective in cell cultures against infection by several unrelated coronaviruses, including SARS-CoV-2 pseudovirions (see the Company’s press release dated October 11, 2021 for details). These studies have established that both NV-CoV-2 and NV-CoV-2-R are broad-spectrum, pan-coronavirus drugs and therefore would remain effective even as variants emerge.
We have successfully developed oral syrup formulations that can be administered easily to anyone including children. Orally administered NV-CoV-2 and NV-CoV-2-R were found to be highly effective in the animal model of coronavirus lethal lung infection caused by h-CoV-NL63 that emulates the lung pathology of SARS-CoV-2 infection.
Oral administration is being presented as the success story of molnupiravir (Merck/Ridgeback). However, an earlier clinical trial of oral molnupitavir in moderate to severe disease was terminated due to lack of efficacy by Merck. It is currently being promoted as a “game-changer” treatment for mild infection despite its marginal effectiveness. This simply attests to the pressing need for oral drugs to combat mild, moderate, and severe COVID-19.
Our drugs NV-CoV-2 and NV-CoV-2-R have both exceeded, in animal studies, the effectiveness of remdesivir, which is approved for treatment of severe hospitalized cases of COVID-19, and has shown substantial clinical benefit in clinical trials in moderate to severe COVID-19 patients. If the strong effectiveness of NV-CoV-2 and NV-CoV-2-R observed in animal studies is borne out in human clinical trials, then our drugs would be substantially more effective than existing therapies. We are developing NV-CoV-2 and NV-CoV-2-R for administration by (a) Injection or Infusion in hospitalized patients, (b) direct lung Inhalation for patients with severe lung disease, as well as (c) oral route for the benefit of pediatric patients as well as non-hospitalized patients.
Previously, the Company has completed pre-clinical development of its lead drug candidate for the treatment of shingles rash, namely, NV-HHV-101. The Company intends to re-engage this program with filing an IND and performing clinical trials for NV-HHV-101 regulatory approvals after our COVID-19 program.
The nanoviricide platform technology is a leading nanomedicine technology that uniquely enables attack on both (a) the virus particles outside cells and (b) the replication of virus inside cells. If both of these factors can be controlled effectively, then the resulting drug could be a cure for the viral disease. In contrast, antibodies only bind to the virus particles outside cells, and tag them for the immune system for further processing, whereas antiviral small chemical drugs affect only the replication cycle of the virus inside cells.
Research and development expenses for the year ended June 30, 2021 were approximately $6.11 Million, compared to about $4.69 Million in the prior year ending June 30, 2020. The increase was primarily due to increased costs of pre-clinical R&D on the COVID-19 drug candidates. General and administrative expenses (G&A) were at about $2.6 Million, compared to $3.3 Million in the prior year. The reduction in G&A is primarily due to decrease in legal, professional, and consulting costs.
For the year ended June 30, 2021, the Company had a net loss of about $8.82 million, or a basic loss per share of $0.81 compared to a net loss of $13.45 Million, or a basic loss per share of $2.39 for the year ended June 30, 2020.
During the fiscal year, we further strengthened our Audit Committee and our Board of Directors with the addition of Mr. Brian Zucker, CPA, effective November, 2020. Mr. Zucker has over thirty years of experience as a CPA specializing in the securities industry. He brings valuable multi-faceted experience with public companies, as well as financings and banking institutions to our Board.
The Company’s drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our intellectual property. The Company has a worldwide exclusive license to this technology for several drugs with specific targeting mechanisms for the treatment of a number of human viral diseases including VZV (shingles), HSV-1 and HSV-2. Additionally, the Company and TheraCour have signed a Memorandum of Understanding for the field of human coronavirus infections, which has provided a limited development license to the Company at no additional cost. A definitive agreement is currently being negotiated between the parties.
The Company intends to perform the regulatory filings and own all the regulatory licenses for the drug candidates it is currently developing. The Company will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials.
Our anti-viral therapeutics, that we refer to as “nanoviricides®” are designed to mimic and look to the virus like the native host cell surface to which it binds. We believe that our drug candidates would be difficult for a virus to escape because these binding sites for a given virus do not change despite mutations and other changes in the virus. Further, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus- binding portion of the nanoviricide is engineered appropriately.
The nanoviricide platform is designed to additionally hold small molecule active pharmaceutical ingredients (API’s) of different types in its “belly”. This allows targeted delivery of the encapsulated API to infected cells, and is also expected to improve the pharmacokinetic and pharmacodynamic properties of the API, such as rapid metabolism. Rapid metabolism is known to be an effectiveness-limiting factor for many drugs, including remdesivir. Remdesivir, developed by Gilead, is a drug that interferes with the replication of the SARS-Cov-2 virus and has been approved under emergency use regulations in the USA as well as in many other countries.
NanoViricides, Inc. (the “Company”) (http://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. We are developing clinical candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs in various pre-clinical stages.
The Company is now working on tasks for completing an IND application for its COVID-19 drug candidates. 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 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 Coronavirus infections, 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’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 that 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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