NNVC NanoViricides Inc.

2.3
-0.25  -10%
Previous Close 2.55
Open 2.55
52 Week Low 2.55
52 Week High 8.71
Market Cap $26,507,500
Shares 11,525,000
Float 10,929,302
Enterprise Value $6,835,155
Volume 140,119
Av. Daily Volume 156,393
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  1. SHELTON, CT / ACCESSWIRE / November 16, 2021 / NanoViricides, Inc. (NYSE: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 2022 with the Securities and Exchange Commission. This press release should be read in conjunction with the Company's Form 10-Q filed yesterday, on November 15, 2021. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465921139231/nnvc-20210930x10q.htm .

    The Company reported that it had approximately $19.89 million of current assets (cash, cash equivalents, and prepaid expenses), and current…

    SHELTON, CT / ACCESSWIRE / November 16, 2021 / NanoViricides, Inc. (NYSE: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 2022 with the Securities and Exchange Commission. This press release should be read in conjunction with the Company's Form 10-Q filed yesterday, on November 15, 2021. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465921139231/nnvc-20210930x10q.htm .

    The Company reported that it had approximately $19.89 million of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $0.87 million, as of September 30, 2021. The Company has no debt, and Stockholder's equity was approximately $28.30 million. During the three-month period ended September 30, 2021 approximately $0.72 million 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 is currently focused on advancing our drug candidates for treatment of patients with SARS-CoV-2 infection towards human clinical trials, in response to the continuing global COVID-19 pandemic. Of these, NV-CoV-2 is designed to act by a novel mechanism of action, that we call "Re-infection Blocker". The Company is working on regulatory submission documents for NV-CoV-2 at present.

    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 has been found to be extremely safe and non-mutagenic in GLP and Non-GLP Safety/Toxicology studies.

    The Company has developed "oral gummies" formulation of NV-CoV-2 successfully. Oral gummies are expected to be more 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.

    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, for rapid recovery of hospitalized patients.

    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.

    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.

    About NanoViricides

    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 are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. 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 now working on tasks for completing an IND application. 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 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.

    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 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. 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.

    Contact:
    NanoViricides, Inc.

    Public Relations Contact:
    MJ Clyburn
    TraDigital IR

    SOURCE: NanoViricides, Inc.



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  2. SHELTON, CT / ACCESSWIRE / November 15, 2021 / NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, announced today that it has developed oral gummies formulations of its Pan-Coronavirus COVID-19 Drug Candidate NV-CoV-2 to benefit non-hospitalized patients. Additionally, the Company has developed formulations for direct inhalation into lungs to benefit severely ill hospitalized patients. The Company also reports strong safety of NV-CoV-2 on several parameters in animal models.

    NV-CoV-2 has been found to be an Extremely Safe and Non-mutagenic Drug, as described below:

    The Company reports that NV-CoV-2 has been found to be non-immunogenic and…

    SHELTON, CT / ACCESSWIRE / November 15, 2021 / NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, announced today that it has developed oral gummies formulations of its Pan-Coronavirus COVID-19 Drug Candidate NV-CoV-2 to benefit non-hospitalized patients. Additionally, the Company has developed formulations for direct inhalation into lungs to benefit severely ill hospitalized patients. The Company also reports strong safety of NV-CoV-2 on several parameters in animal models.

    NV-CoV-2 has been found to be an Extremely Safe and Non-mutagenic Drug, as described below:

    The Company reports that NV-CoV-2 has been found to be non-immunogenic and non-allergenic. Further, it has not caused any hypersensitivity or adverse reactions at injection site or other adverse events in multiple animal studies. It was safe and well tolerated at very high dosages in single and multiple-dosing studies below the maximum tolerable dose (MTD) in animal models, based on available data. The maximum tolerable dosage in rats was determined to be 1,500 mg/Kg.

    The Company also reports that NV-CoV-2 has been found to be non-mutagenic in a standard GLP Ames Test.

    The Company believes that the extremely strong safety observed in animal models should be indicative of a strong safety signal anticipated in Phase 1 human clinical trials.

    The non-immunogenicity, non-allergenicity, and lack of hypersensitivity or adverse reactions at injection site seen in animal models with single and repeated injections leads the Company to postulate that it may be possible to give a therapeutic dose of NV-CoV-2 in humans via a simple slow-push injection rather than an infusion. If this proves out in clinical trials, it would enable treating moderate cases without hospitalizing the patients. This is an important unmet need that would help significantly reduce the severe and intense load on hospitals and health-care workers that occurs during the waves of the global COVID-19 pandemic.

    NV-CoV-2 and NV-CoV-2-R Drug Formulations for Oral, Injectable, Infusion, and Direct Lung Inhalation:

    NanoViricides has developed formulations of both NV-CoV-2 and NV-CoV-2-R to meet the needs of different levels of disease severity and different types of patients.

    The Company has recently completed the development of an oral gummies ("chewable gel") formulation of NV-CoV-2. The Company believes that this formulation may have advantages in terms of drug bioavailability over oral pills, because of partial sublingual absorption that avoids the gastrointestinal tract. NanoViricides maintains that this oral gummies formulation would be very attractive to patients, especially children, over oral pills. This formulation would be for the benefit of symptomatic non-hospitalized patients, Additionally, the simplicity of administration is expected to enable its prophylactic use as well.

    The Company has previously developed an injectable formulation of NV-CoV-2 that it believes may not require infusion, allowing treatment of severe cases without hospitalization. This is an important unmet need for reducing strain on hospital systems during waves of the global COVID-19 pandemic.

    Previously, the Company has developed formulations for infusion for both NV-CoV-2 and NV-CoV-2-R, to treat severely ill hospitalized patients.

    NanoViricides has also very recently developed formulations of both NV-CoV-2 and NV-CoV-2-R for direct inhalation into lungs using a simple nebulizer. This inhalation formulation is developed to benefit very severely ill patients with significant lung pathology. Direct inhalation of the drug would result in highest possible levels of the drug to be achieved in lungs thereby maximizing antiviral effect, and minimizing lung viral load. This is expected to help minimize lung damage, enabling the patient to recover rapidly.

    The Company has previously demonstrated that NV-CoV-2 was highly effective in multiple cell culture studies against unrelated coronaviruses including SARS-CoV-2 (S-protein pseudovirion), h-CoV-NL63 (NL63), and h-CoV-229E (229E). 229E causes common colds. NL63 causes a COVID-19-like lung pathology in humans, but the disease is not very severe. SARS-CoV-2 has caused the current global pandemic that continues with multiple waves driven by evolution of new variants. Thus the Company has established the broad-spectrum pan-coronavirus activity of NV-CoV-2.

    As new variants emerge, the effectiveness of vaccines has continued to drop, the protection from the antibodies developed in response to the vaccine has continued to decrease, and antibody drugs have become progressively less effective. Thus a broad-spectrum pan-coronavirus drug is needed to help end the pandemic. NanoViricides has recognized this need right at the onset and believes it has successfully developed drug candidates that precisely satisfy this as-yet unmet need.

    NanoViricides asserts that there is a much lower probability of generation of escape mutants against NV-CoV-2 (as compared to the classical types of drugs) (1) because it is designed to create a multi-point attack on the virus thereby completely disrupting the virus structure, and (2) because of the observed broad-spectrum activity of NV-CoV-2 against multiple types of distinctly different coronaviruses including SARS-CoV-2.

    "We believe that NV-CoV-2 and NV-CoV-2-R would be highly effective drugs against SARS-CoV-2, based on multiple animal studies data," commented Dr. Anil Diwan, Chairman and President of the Company, adding, "We believe that NV-CoV-2 may help end the pandemic if it is shown to be effective in human clinical trials."

    About NanoViricides

    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.

    Contact:
    NanoViricides, Inc.

    http://www.nanoviricides.com

    Public Relations Contact:
    MJ Clyburn
    TraDigital IR

    SOURCE: NanoViricides, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/672810/NanoViricides-Completes-Oral-Gummies-and-Lung-Inhalation-Formulations-Development-for-its-Non-Mutagenic-Safe-Broad-Spectrum-COVID-19-Clinical-Drug-Candidate-NV-CoV-2

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  3. SHELTON, CT / ACCESSWIRE / October 13, 2021 / NanoViricides, Inc. (NYSE: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…

    SHELTON, CT / ACCESSWIRE / October 13, 2021 / NanoViricides, Inc. (NYSE: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.

    About NanoViricides

    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.

    Contact:

    NanoViricides, Inc.

    www.nanoviricides.com

    Public Relations Contact:
    MJ Clyburn
    TraDigital IR

    SOURCE: NanoViricides, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/667865/NanoViricides-Inc-Has-Filed-its-Annual-Report-Coronavirus-Drug-Program-Rapidly-Moving-Towards-Clinical-Stage

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  4. SHELTON, CT / ACCESSWIRE / October 11, 2021 / NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, announced today that its Pan-Coronavirus COVID-19 Drug Candidate NV-CoV-2 was found to be effective against SARS-CoV-2 in a standard cell culture pseudovirion assay, demonstrating that the drug indeed has broad-spectrum pan-coronavirus activity. This pan-coronavirus activity implies that the drug NV-CoV-2 should remain active in spite of evolution of variants of SARS-CoV-2 in the field, a highly sought-after characteristic to combat the current global pandemic.

    In this assay, both the drug candidate NV-CoV-2 and a positive control antibody…

    SHELTON, CT / ACCESSWIRE / October 11, 2021 / NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, announced today that its Pan-Coronavirus COVID-19 Drug Candidate NV-CoV-2 was found to be effective against SARS-CoV-2 in a standard cell culture pseudovirion assay, demonstrating that the drug indeed has broad-spectrum pan-coronavirus activity. This pan-coronavirus activity implies that the drug NV-CoV-2 should remain active in spite of evolution of variants of SARS-CoV-2 in the field, a highly sought-after characteristic to combat the current global pandemic.

    In this assay, both the drug candidate NV-CoV-2 and a positive control antibody specific to the Spike antigen S1 of the SARS-CoV-2 virus suppressed the infection by the SARS-CoV-2-pseudovirions in cell culture studies to virtually the same baseline levels.

    We have now demonstrated that NV-CoV-2 is highly effective in cell cultures against SARS-CoV-2, human coronavirus NL-63, and human coronavirus 229E, all very different human coronaviruses. These results imply that the drug will remain active in spite of novel variants of SARS-CoV-2 evolution in the field, and indeed demonstrate the pan-coronavirus activity of our clinical drug candidate NV-CoV-2.

    Additionally, the pseudovirion study also showed that NV-CoV-2 neutralizes the virus particles themselves, outside of the cells, validating our design mechanism.

    "We are now preparing submission documents to enable initiation of human clinical trials," commented Dr. Anil Diwan, Chairman and President of the Company, adding, "We believe that NV-CoV-2 may help end the pandemic if it is shown to be effective in human clinical trials."

    A strong SARS-CoV-2 infection inhibition activity of NV-CoV-2 was observed in this pseudovirion study. Pseudovirion assay is a standard method for evaluating virus entry-inhibitors in BSL2 laboratories and is primarily used for viruses that would otherwise require high security BSL3 or BSL4 laboratories. In this study, SARS-CoV-2-pseudovirion virus particles were made that carry a green fluorescent protein (GFP) producer mRNA inside, and use the SARS-CoV-2 S1 protein on their surface to bind to ACE2 receptor protein on cells. They were incubated with NV-CoV-2 (test article), or a known neutralizing antibody (positive control), or just the vehicle buffer (negative control). Then these solutions were separately used to infect ACE2 positive cells and the cultures were incubated. Only the infected cells produced GFP and were visualized by green fluorescence in microscopy. In this well-known assay, NV-CoV-2 was as effective as the neutralizing antibody in reducing the virus infection. This study demonstrates that NV-CoV-2 attacks the SARS-CoV-2 pseudovirion particles and renders them incapable of binding to the ACE2 positive cells.

    A "pseudovirion" is a virus particle made of a BSL-2 virus shell, but with its original cell-binding protein replaced by the cell binding protein of a BSL3 or BSL4 virus, in this case, the S1 antigen of SARS-CoV-2. Additionally, the pseudovirion particle contains an mRNA that is packaged like the original virus, except that the mRNA is edited and redesigned so that it cannot produce infectious virus particles. In our study, this mRNA allowed expression and production of the green fluorescent protein (GFP) enabling visual detection of the infected cells (green) in microscopy.

    About NanoViricides

    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.

    Contact:

    NanoViricides, Inc.

    http://www.nanoviricides.com

    Public Relations Contact:

    MJ Clyburn
    TraDigital IR

    SOURCE: NanoViricides, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/667514/NanoViricides-Announces-COVID-19-Clinical-Drug-Candidate-NV-CoV-2-was-Effective-Against-SARS-CoV-2-Further-Demonstrating-Its-Broad-Spectrum-Pan-Coronavirus-Activity

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  5. SHELTON, Conn., Oct. 5, 2021 /CNW/ -- NanoViricides, Inc. (NYSE:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, presented an update of its Pan-Coronavirus COVID-19 Drug Development Program at the Benzinga Healthcare Small Cap Conference on September 30, 2021 at 10:10am EST.

    "The Only Dual Mode Drug in Development Against COVID-19 To Block Complete LifeCycle of the Virus for a Potential Cure"

    In the  "Pan-coronavirus Broad-spectrum Nanomedicines NV-CoV-2 and NV-CoV-2-R to Attack the SARS-CoV-2 Virus and its Variants in the Global Pandemic" presentation, Dr. Diwan discussed the current status of NanoViricides' COVID-19 drug development program.

    An updated Corporate Presentation that encompasses Dr. Diwan's presentation at the Benzinga Conference will be available shortly on the Company's website on its home page (www.nanoviricides.com).

    Highlights of the Presentation:

    • TWO Drug Candidates, NV-CoV-2 and NV-CoV-2-R in Development to Enter Clinical Trials
    • Both Possess Broad-Spectrum Activities Against Many Coronaviruses
      • Both Are Thus Expected to Continue to Work Against Variants
      • Even as SARS-CoV-2 Continues to Evolve with Increasing Resistance to Existing Drugs and Antibodies
      • Variants Would Therefore Not be Able to Escape Our Drugs, Particularly NV-CoV-2-R
    • Novel Mechanism of Action, Unlike Existing Drugs
    • NV-CoV-2-R is the Only Drug in Development with a Dual Mode of Action
      • Block Virus from Attacking Cells in the first place, and
      • Inhibit Virus Replication Inside Cells, Simultaneously
    • NV-CoV-2-R is the Only Drug in Development that Blocks the Complete Lifecycle of the Virus
      • NV-CoV-2 Component Neutralizes Virus Outside Cells Blocking Reinfection Cycle
      • Remdesivir Component Blocks the Replication Cycle Inside Cells
      • Makes it very difficult for virus to escape the drug
    • Animal Model Studies Have Indicated that Both NV-CoV-2 and NV-CoV-2-R are Substantially Superior to Remdesivir in Controlling Coronavirus Lethal Lung Infection
      • Lifespan Extension Over Untreated Infected Animals:
        • Remdesivir: 2.5 days (Only 50% Increase)
        • NV-CoV-2: 14 days (180% Increase)
        • NV-CoV-2-R: 16 days (220% Increase).
    • Both NV-CoV-2 and NV-CoV-2-R are Extremely Safe
      • NV-CoV-2 Well Tolerated at >3.3 g/kg Body Weight in Rats by I.V. Infusion
      • NV-CoV-2-R Well Tolerated at >1.8 g/kg Body Weight in Rats by I.V. Infusion
      • Anticipate Substantial Therapeutic Margin of Safety in Clinical Studies
    • Required GLP Safety/Toxicology Studies of NV-CoV-2 Completed
      • No Respiratory or Neurological Function Adverse Effects in a GLP Rat Neuro-Pulmonary Model Studies
      • No Cardiovascular Function Adverse Effects in a GLP Study in Cynomolgus Monkey (Non-Human Primate) Model

    "Importantly, NV-CoV-2 can be administered orally, and was found to be effective given orally in an animal model," Dr. Diwan added, "Oral NV-CoV-2 should enable highly effective treatments for pediatric use, an urgent medical need that remains unmet with even the most talked about current drug developments".

    About the Benzinga Healthcare Small Cap Conference

    The Benzinga Healthcare Small Cap Conference bridges the gap between Small Cap companies, investors, and traders. Learn about small cap investing with clearly defined Educational Modules, take a look at a curated group of Small Cap investment opportunities, and connect with the healthcare Small Cap audience in an intimate, virtual setting. We invite investors and all interested parties to explore healthcare small cap investment opportunities through two days of networking, dealmaking and discovery. For more information and/or to register for the conference please visit: https://www.benzinga.com/events/small-cap/healthcare/.

    About NanoViricides

    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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    SOURCE NanoViricides, Inc.

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