DGAP-News: NanoViricides, Inc. / Key word(s): Annual Report NanoViricides, Inc. Has Filed its Annual Report: Coronavirus Drug Program Rapidly Moving Towards Clinical Stage 2021-10-13 / 12:45 The issuer is solely responsible for the content of this announcement.

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NanoViricides, Inc. Has Filed its Annual Report: Coronavirus Drug Program Rapidly Moving Towards Clinical Stage

SHELTON, CT / ACCESSWIRE / October 13, 2021 / NanoViricides, Inc. (NYSE Amer.: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 USD20.8 Million. In addition, we reported USD9.08 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 USD0.4 Million. In comparison, as of June 30, 2020, we had cash and cash equivalent balance of approximately USD14 Million, P&E assets of approximately USD9.54 Million, and total current liabilities of approximately USD2.15 Million.

During the fiscal year ended June 30, 2021. we raised approximately USD10.4 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 USD6.1 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 USD6.11 Million, compared to about USD4.69 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 USD2.6 Million, compared to USD3.3 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 USD8.82 million, or a basic loss per share of USD0.81 compared to a net loss of USD13.45 Million, or a basic loss per share of USD2.39 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.

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October 13, 2021 06:45 ET (10:45 GMT)