Author: NanoViricides

  • NanoViricides Announces Pricing of $6 Million Registered Direct Offering and Concurrent Private Placement Priced at the Market Close

    NanoViricides Announces Pricing of $6 Million Registered Direct Offering and Concurrent Private Placement Priced at the Market Close

    SHELTON, CONNECTICUT / ACCESS Newswire / November 11, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), today announced that it has entered into a securities purchase agreement with a single healthcare institutional investor for the purchase and sale of 3,571,429 shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.68 per share in a registered direct offering (the “Offering”). The gross proceeds from the Offering are expected to be approximately $6 million, before deducting placement agent commissions and other offering expenses. In addition, in a concurrent private placement, the Company will issue and sell Series A warrants to purchase up to 3,571,429 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to 3,571,429 shares of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Warrants”). The Series A Warrants will have an exercise price of $1.75 per share, will be exercisable after 6 months from date of issuance, and will expire 2 years following the issuance date. The Series B Warrants will have an exercise price of $2.00 per share, will be exercisable after 6 months from date of issuance, and will expire 5.5 years following the issuance date. The exercise price of the Series B Warrants represents approximately a 20% premium to the closing price for the Company’s common stock on November 10, 2025. The closing of the Offering is expected to occur on or about November 12, 2025, subject to the satisfaction of customary closing conditions.

    The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

    A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the offering.

    The common stock (and common stock equivalents in lieu thereof) offered to the institutional investor described above are being offered pursuant to a registration statement on Form S-3 (File No. 333-271706) which was declared effective by the Securities and Exchange Commission (the “SEC”) on May 22, 2023. The offering is being made only by means of a prospectus supplement and accompanying prospectus which are a part of the effective registration statement. The Warrants will be issued in a concurrent private placement. A prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the prospectus supplement and the accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.

    The private placement of the Warrants and the shares underlying the warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended, (the “Securities Act”) and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About NanoViricides

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    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 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 SEC 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:

    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    SOURCE: NanoViricides

    View the original press release on ACCESS Newswire

  • NanoViricides Annual Shareholders Meeting to be Held at 10 am on Saturday, November 5th at on Saturday, November 8, 2025, at the Hampton Inn & Suites Stamford, CT

    NanoViricides Annual Shareholders Meeting to be Held at 10 am on Saturday, November 5th at on Saturday, November 8, 2025, at the Hampton Inn & Suites Stamford, CT

    NV-387 Could be the Answer to the MPox Clade I Rising in the USA, Says Dr. Diwan

    SHELTON, CONNECTICUT / ACCESS Newswire / November 5, 2025 / NanoViricides, Inc. (NYSE American:NNVC ) (the “Company”), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that the Company will be holding its Annual Shareholders Meeting at 10 am on Saturday, November 8th, 2025, at the Hampton Inn & Suites Stamford, CT.

    Event Information:

    Event

    NanoViricides Annual Shareholders Meeting

    Date

    Saturday, November 8, 2025

    Time

    10:00 am

    Location

    Hampton Inn & Suites Stamford, 26 Mill River Street, Stamford CT 06902.

    Requirements

    Only current shareholders are eligible to attend. No recording using any devices will be permitted. Any reporters, journalists, or writers must identify themselves with their affiliation at the registration desk. Company retains the right to inspect the attendee’s valid US identification.

    Anil R. Diwan, PhD, President and Executive Chairman of the Company will review the Company’s progress towards clinical trials, and the near future planned clinical trials.

    Currently, the Company is fully engaged in completing the Clinical Trial Application (CTA) and initiating a Phase II clinical trial for the evaluation of NV-387 as a treatment for MPox. This clinical trial will be conducted in the Democratic Republic of Congo (DRC). The more severe strains of MPox Clade Ia and Clade Ib are prevalent in DRC. In contrast, the less severe Clade IIa and IIb strains have become endemic in certain Western countries including the USA, but only in specific populations such as men having sex with men (MSM), and HIV-infected immunocompromised patients. MPox Clade II is prevalent in Western African countries.

    Recently, three new MPox Clade I cases have occurred in California. All three cases required hospitalization, but are recovering. These cases were not related to travel to the African countries, and authorities suspect that community spread with asymptomatic transmission may be occurring (https://thehill.com/policy/healthcare/5572528-california-mpox-concerns/). This raises the possibility of MPox Clade I spreading further either as small outbreaks, as we have witnessed for Measles recently, or as local epidemics. The potential for a widespread pandemic is low because transmission of the virus requires close dermal contact with infected skin lesions. However, preparedness is warranted.

    The case fatality rate (CFR) of MPox Clade I has ranged from about 9% down to 1.5%. This decline has been attributed to improved standard of care. In contrast, the CFR for MPox Clade II is low, at about 0.2%.

    There is no approved treatment for MPox. For prevention, a smallpox vaccine called Jynneos® is said to have a vaccine effectiveness rate of 66% with two doses and 36% with a single dose in MPox Clade II (N Engl J Med 2023;388:2434-43, DOI: 10.1056/NEJMoa2215201).

    “We believe NV-387 could be the answer to the challenges posed by rising MPox Clade I cases, and also the on-going MPox Clade II cases, in the USA,” declared Anil R. Diwan, PhD, President of the Company, asserting, “The current countermeasures in the US Government Strategic National Stockpile are clearly deficient and inadequate for an effective public health response to a MPox epidemic should the virus spread further.”

    A drug approved for smallpox under the FDA “Animal Rule”, namely TPOXX ® (tecovirimat) was mobilized during the 2022 MPox Clade II epidemic. Clinical trials of this drug failed to prove effectiveness in treating MPox Clade I or Clade II infections. The utility of tecovirimat as a treatment is questionable because a single point mutation in a viral protein enables the virus to escape the drug.

    Another drug, TEMBEXA® (brincidofovir) was also approved for smallpox under the FDA “Animal Rule”. Its clinical trial (called “MOSA”) for treating MPox in Africa started with fanfare in January, 2025, and top-line results were promised by end of first quarter of 2025. The current status of this clinical trial is unknown. The utility of TEMBEXA for treating MPox in an epidemic scenario is highly questionable because the drug carries a “black box warning”, requires medical monitoring after dosing, produces gastrointestinal adverse events, produces hepatic adverse events, has caused discontinuations in 5% of patients in clinical trials, is a known mutagen, carcinogen, teratogen, has embryo-fetal toxicity risk, and may cause male infertility, according to the drug prescribing information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf).

    TPOXX and TEMBEXA, as potential treatments, and Jynneos as a preventative vaccine, have been stockpiled by the US Government as preparedness measures for potential smallpox bioterrorism event, and have been mobilized in response to MPox cases.

    In contrast to these drugs, NV-387 has demonstrated a strong safety and tolerability profile in Phase I healthy subjects clinical trial, and in non-clinical animal model studies. NV-387 has also demonstrated strong effectiveness in animal models of orthopoxvirus infections when directly compared with tecovirimat. The virus is highly unlikely to escape the attack by NV-387 because the drug NV-387 is created by mimicking the host-side “landing sites” of the virus in the human body, which do not change even as the virus mutates.

    ABOUT NANOVIRICIDES

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:
    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    SOURCE: NanoViricides, Inc.

    View the original press release on ACCESS Newswire

  • NanoViricides to Present at the Spartan Capital Investor Conference 2025 in New York City Today, November 3rd

    SHELTON, CONNECTICUT / ACCESS Newswire / November 3, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that it will be presenting today, Monday, November 3rd, at 09:45am ET at the Spartan Capital Investor Conference 2025 in New York City.

    Event Information:

    Event

    NanoViricides Presentation at the Spartan Capital Investor Conference – 2025, New York, NY

    Track

    2

    Date

    Monday, November 3, 2025

    Time

    09:45am

    Location

    Marriott Marquis Hotel, New York, NY

    Anil R. Diwan, PhD, President and Executive Chairman of the Company will provide an update on the Company, its Drug Pipeline and Platform Technologies available for licensing.

    NanoViricides’ Current Antiviral Drugs Pipeline: NV-387, A Revolutionary Broad-Spectrum Antiviral with Multiple Indications

    The Phase II clinical stage revolutionary broad antiviral spectrum of NV-387 is reminiscent of the dawn of antibiotics to combat bacterial infections. Over 90% of human pathogenic viruses use heparan sulfate features, which NV-387 copies and presents to fool the virus.

    NV-387 is designed to attack the virus particle and destroy it by fooling the virus to enter the NV-387 nanomicelle using the same features that the virus uses to infect cells.

    Viruses cannot escape NV-387 despite all the changes in the field because the virus still needs to bind to heparan-sulfate like features in order to cause productive pathogenic infection. NV-387 presents copious amounts of these binding sites to the virus, thereby engulfing the virus particle. Viruses are unlikely to escape NV-387 because no matter how much a virus evolves, it continues to utilize and require binding to sulfated proteoglycans – the very characteristic that NV-387 emulates.

    This solves the long-standing problem of antiviral medicines, that viruses escape them. Vaccines, antibodies and small chemical drugs are readily escaped by viruses as the viruses evolve in the field. This has been repeatedly observed during the recent COVID-19 pandemic, as well as in the course of most of the other viral epidemics including Influenza and HIV/AIDS.

    NV-387 stands to combat viral infections where there is no current medical treatment available, including RSV for pediatrics, Measles, MPox, and others.

    NanoViricides lead clinical stage drug candidate NV-387 is rapidly moving into Phase II clinical trial for the treatment of MPox in the Democratic Republic of Congo.

    Additionally, NV-387 was found to be substantially superior to Tamiflu as well as Xofluza against Influenza virus in animal model studies [1].

    Should Bird Flu H5N1 turn into a human outbreak, variants resistance to Tamiflu and Xofluza can be expected to generate rapidly [2]. NV-387 would be the ideal drug to combat the resulting outbreak, epidemic or pandemic. The causative influenza virus would not be able to escape NV-387 [3].

    A separate Phase II clinical trial for the evaluation of NV-387 as a first line therapy of any respiratory viral infection (NV-387 for the treatment of Viral Acute or Severe Acute respiratory Infections, Viral ARI/SARI) is being planned. Success in this clinical trial would enable NV-387 to become the first ever antiviral drug that can be prescribed by a physician based on symptoms, as an emperic therapy for respiratory viral infections, without having to test for which virus is causing the disease.

    NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for such emperic therapy of viral ARI/SARI.

    NV-387 was found to be highly effective against the “tripledemic” respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. NV-387 was found to be substantially superior to existing drugs, and even resulted in complete cure in the RSV animal study. These studies prompted evaluation of NV-387 as a first line therapy of respiratory viral infections.

    There is no treatment approved for RSV, an important disease for infants and children in early life, as well as for geriatric subjects.

    NV-387 has shown excellent effectiveness in lethal lung infection animal models relevant for Smallpox and MPox viruses.

    There is no treatment approved for MPox; tecovirimat (TPOXX) has failed clinical trials, and no results are available from the brincidofovir (TEMBEXA) clinical trial “MOSA”.

    “For Smallpox bio-threat readiness, the USA remains without an effective drug because of deficiencies in the two drugs approved under animal rule [4],” asserted Anil Diwan, PhD, President of the Company, adding, “NV-387 is ready to fill this gap.”

    US government acquisitions for smallpox drugs have been in the range of hundreds of millions of dollars.

    Additionally, NV-387 has shown excellent effectiveness against Measles virus lethal lung infection in a humanized (hCD150+ knock-in) mouse model.

    There is no treatment approved for Measles. Cases of Measles have been rapidly rising in the developing world including USA, Canada, UK and European countries. Measles is an important health threat because the disease can lead to “immune amnesia”, wiping out pre-developed immunity against other diseases, because it attacks the immune system itself.

    NanoViricides’ Robust Technology Platform Has Enabled a Broad Drugs Pipeline: HerpesViruses, HIV, Others

    The nanoviricides™ platform technology is yielding novel antiviral drug candidates against a number of challenging viral targets at a rapid pace.

    In addition to NV-387, the Company has developed a clinical-ready pan-herpesvirus drug candidate, NV-HHV-1 that has shown activity against HSV-1, HSV-2 and VZV, and is expected to have activity against CMV, HHV-6, and HHV-8 as well.

    The Company has also developed an anti-HIV drug candidate, NV-HIV-1, that has shown strong efficacy in SCID-hu-Thy-Liv animal model of HIV infection. NV-HHV-1 mimics the landing site on cellular CD4 that is required for all HIV viruses to cause cellular infection. Thus, HIV, despite constant changes, will be unable to escape NV-HHV-1.

    NanoViricide Platform Enables Drug Rescue, Oral Drug Delivery, and Zip-Code Specific Delivery

    Oral drug delivery of small chemicals, peptides (such as the GLP-a obesity drugs), and proteins is feasible by encapsulation of the guest drug into the nanoviricide polymeric micelle. The encapsulation protects the guest from metabolism thereby enabling effective drug delivery.

    Encapsulation of a difficult or failed drug within the nanoviricide polymeric micelle can enable rescue of the drug candidate turning it into a clinically viable drug candidate, saving hundreds of millions of dollars of development work.

    Going another step further, the nanoviricide platform technology can be customized to enable zip-code-like specific delivery of encapsulated drugs to specific tissues (e.g. non-liver targeted delivery),, cells (e.g. cancer-cell specific delivery sparing normal cells), bacteria, or viruses (e.g. NV-HHV-1, NV-HIV-1) in a fully synthetic chemistry based, scalable technology stack.

    ABOUT THE SPARTAN CAPITAL INVESTOR CONFERENCE 2025

    The Spartan Capital Investor Conference is a premier event that brings together public company executive teams, institutional investors, thought leaders in the U.S. capital markets, and representatives from Spartan Capital. This conference offers a unique opportunity for networking, knowledge sharing, and strategic discussions.

    ABOUT NANOVIRICIDES

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:
    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    [1] Tamiflu (Oseltamivir) – Roche. Xofluza (Baloxavir) – Shionogi, Roche. H5N1 bird flu viruses resistant to Oseltamivir have already occurred. Resistance to Xofluza occurred at a high frequency in its clinical trial.

    [2] Influenza viruses generate variants by more mechanisms than most viruses: (a) by mutations, typically few and small changes in viral proteins; (b) by recombinations, wherein portions of its genomic strands are swapped between the strands derived from two different Influenza A viruses infecting the same cell; (c) by re-assortments, wherein entire genomic segment from one Influenza A virus is packaged into a different Influenza A virus in the same cell. Each complete Influenza A virus contains eight separate genomic RNA strands, giving it tremendous flexibility for “swapping” these segments and generating new variants. It is thought that all influenza A viruses causing outbreaks or pandemics among humans since the 1900s originated from strains circulating in wild aquatic birds through reassortment with other influenza strains (wikipedia, https://en.wikipedia.org/wiki/Influenza_A_virus).

    [3] All Influenza viruses bind to HSPG (heparan sulfate proteoglycan) as the first “attachment receptor”, and thus are targeted by the drug NV-387. The viruses then gain proximity to cells, and latch onto the Sialylated glycoproteins on the cell surface which is called the “cognate receptor” that enables the virus to be taken inside the cell. The cognate receptor for Influenza viruses that remain infectious to birds is slightly different from the one that the virus would need to use for efficiently infecting human cells. However, just one or a few mutations would be required in the currently circulating H5N1 bird flu viruses to become efficient in human-to-human transmission. Two different clades of H5N1 are circulating, one in wild birds, infecting into poultry, and another in dairy cattle, infecting pets and animals that drink raw milk, bringing the threat closer to a potential pandemic than it has ever been since the late 1990s.

    [4] Tecovirimat (TPOXX) was approved under the US FDA Animal Rule, and is stockpiled by the US Government Strategic National Stockpile (SNS). However, Tecovirimat-resistant viruses develop with a single point mutation in the viral VP37 protein. It is illogical to believe that any terrorist attack would be from a non-resistant smallpox strain. Brincidofovir (Tembexa) was approved under the US FDA Animal Rule, and is stockpiled in SNS. Brincidofovir carries a black box warning due to increased mortality rates in another indication, causes elevation of liver damage-related markers, is a carcinogen, may cause embryonic or fetal harm, and may irreversibly impair fertility, according to its prescribing information, limiting its applicability as a drug to be used across all population in the case of a smallpox bio-terrorism event (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214460s000,214461s000lbl.pdf.).

    SOURCE: NanoViricides

    View the original press release on ACCESS Newswire

  • Treating Measles Infection: Nanoviricides CEO Dr Anil Diwan Interviewed by Steve Darling from Proactive

    SHELTON, CONNECTICUT / ACCESS Newswire / October 29, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company”), announced that Nanoviricides CEO Dr Anil Diwan joined Steve Darling from Proactive to share major progress in the company’s antiviral research in a video interview. The interview can be viewed at https://youtu.be/m_3Yk4_832E .

    From the Proactive website, explaining the video content (https://www.proactiveinvestors.com/companies/news/1081157/nanoviricides-nv-387-shows-potent-anti-measles-activity-highlighting-broad-spectrum-potential.html):

    “Dr. Diwan shared that the Company’s clinical lead drug NV-387 has demonstrated potent activity against the Measles virus in both cell culture studies and a humanized animal model. Notably, the treatment also protected lung tissue, a critical factor in preventing death from severe, late-stage viral infections. Currently, there are no approved drugs for treating Measles, making these findings especially significant amid rising global outbreaks.

    Dr. Diwan explained that NV-387 produced direct antiviral effects in standard Cytopathic Effects assays, where treated cells showed increased survival compared to untreated controls. In the lethal Measles infection model, NV-387 treatment extended survival by 130% – from 7.4 days in untreated animals to 17 days in treated ones – underscoring its strong therapeutic potential [1].

    Importantly, NV-387 has already completed Phase I human trials, demonstrating no reportable adverse events and confirming that the drug is safe and well tolerated in healthy subjects.

    Dr. Diwan added that NanoViricides is now positioned to support emergency use applications of NV-387 for Measles patients under FDA guidelines. The company is also open to Physician’s Investigator-Initiated INDs for treating individual or small groups of patients in urgent cases. NV-387 is formulated as oral gummies, which dissolve slowly in the mouth and do not require swallowing – a key advantage for patients suffering from rashes or throat irritation associated with Measles infection.

    The same drug, NV-387 is advancing into Phase II clinical trial for the evaluation of safety and effectiveness in the treatment of MPox, noted Dr. Diwan. There is no approved treatment for MPox. “

    ABOUT NANOVIRICIDES

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:
    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    [1] Added explanation: Humanized mice were required for the animal model because Measles virus only infects humans, and specifically uses hSLAM as the cognate receptor for cell entry, while using the ubiquitous HSPG for congregation next to cells. The mice had human hSLAM (aka hCD150) gene knocked-in, and also had their interferon responses deleted (hSLAM+k.i., IfnAR-/- transgenic mice on C57BL/6 Background). NV-387 mimics the portions on HSPG that viruses bind to, including the Measles virus, and thereby is designed to attack and engulf the virus particle via lipid-lipid mixing and destroying the virus particle’s ability to infect cells.

    SOURCE: NanoViricides

    View the original press release on ACCESS Newswire

  • NanoViricides to Present at the PODD 2025 Conference in Boston on October 27

    SHELTON, CT / ACCESS Newswire / October 27, 2025 / NanoViricides, Inc. (NYSE American: NNVC ) (the “Company”), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that it will be presenting on Monday, October 27th, at 03:00pm at the PODD 2025 Conference in Boston, MA.

    Event Information:

    Event

    NanoViricides Presentation at the PODD 2025, Boston, MA

    Track

    5A

    Date

    Monday, October 27, 2025

    Time

    03:00 pm

    Location

    St. George, ABC, at Westin Copley Hotel, Boston, MA

    Anil R. Diwan, PhD, President and Executive Chairman of the Company will provide an update on the Company, its Drug Pipeline and Platform Technologies available for licensing.

    NanoViricides’ Current Antiviral Drugs Pipeline

    NanoViricides lead clinical stage drug candidate NV-387 is rapidly moving into Phase II for the treatment of MPox in the Democratic Republic of Congo.

    A separate Phase II clinical trial for the evaluation of NV-387 as a first line therapy of any respiratory viral infection (NV-387 for the treatment of Viral Acute or Severe Acute respiratory Infections, Viral ARI/SARI, is being planned. Success in this clinical trial would enable NV-387 to become the first ever antiviral drug that can be prescribed by a physician based on symptoms, as an emperic therapy for respiratory viral infections, without having to test for which virus is causing the disease.

    The revolutionary broad antiviral spectrum of NV-387 is reminiscent of the dawn of antibiotics to combat bacterial infections.

    NV-387 was found to be highly effective against the “tripledemic” respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. NV-387 was found to be substantially superior to existing drugs, and even resulted in complete cure in the RSV animal study. These studies prompted evaluation of NV-387 as a first line therapy of respiratory viral infections.

    There is no treatment approved for RSV.

    NV-387 has shown excellent effectiveness in lethal lung infection animal models relevant for Smallpox and MPox viruses.

    There is no treatment approved for MPox; tecovirimat (TPOXX) has failed clinical trials, and no results are available from the brincidofovir (TEMBEXA) clinical trial “MOSA”.

    Additionally, NV-387 has shown excellent effectiveness against Measles virus lethal lung infection in a humanized (hCD150+ knock-in) mouse model.

    There is no treatment approved for Measles. Cases of Measles have been rapidly rising in the developing world including USA, Canada, UK and European countries. Measles is an important health threat because the disease can lead to “immune amnesia”, wiping out pre-developed immunity against other diseases, because it attacks the immune system itself.

    The nanoviricides™ platform technology is yielding novel antiviral drug candidates against a number of challenging viral targets at a rapid pace.

    Our most advanced candidate, NV-387, is an ultra-broad-spectrum antiviral with potential activity against most respiratory human pathogenic viruses – and more, because it emulates the attachment receptor family of sulfated proteoglycans that over 90% of human viruses utilize.

    Moreover, NV-387 is designed to shape-shift upon binding to the virus particle, in the process disrupting the virus particle and making it incapable of infection, as a complete chemical nanomachine that destroys the virus.

    Viruses are unlikely to escape NV-387 because no matter how much a virus evolves, it continues to utilize and require binding to sulfated proteoglycans – the very characteristic that NV-387 emulates. This solves the long-standing problem of antiviral medicines, that viruses escape them. Vaccines, antibodies and small chemical drugs are readily escaped by viruses as the viruses evolve in the field. This has been repeatedly observed during the recent COVID-19 pandemic, as well as in the course of most of the other viral epidemics including Influenza and HIV/AIDS.

    Continued redevelopment or “updating” of vaccines necessitated by the viral escape or drift has recurrently cost billions of dollars every year for Influenza as well as COVID. NV-387 promises to make such costly endeavors unnecessary, once this drug is approved by regulatory bodies.

    NV-387 is rapidly moving towards Phase II Safety, Tolerability and Efficacy Evaluation for the Treatment of MPOX disease, in response to the continuing Public Health Emergency of International Concern in WHO African Region. We already have received preliminary approval of the clinical protocol and the study and now we are working diligently to finish and submit the clinical trial application.

    The overall market size of NV-387 indications is estimated to be well in excess of $10 billion.

    In addition, the Company has developed a clinical-ready pan-herpesvirus drug candidate, NV-HHV-1 that has shown activity against HSV-1, HSV-2 and VZV, and is expected to have activity against CMV, HHV-6, and HHV-8 as well.

    The Company has also developed an anti-HIV drug candidate, NV-HIV-1, that has shown strong efficacy in SCID-hu-Thy-Liv animal model of HIV infection. NV-HHV-1 mimics the landing site on cellular CD4 that is required for all HIV viruses to cause cellular infection. Thus, HIV, despite constant changes, will be unable to escape NV-HHV-1.

    NanoViricide Platform Enables Drug Rescue, Oral Drug Delivery, and Zip-Code Specific Delivery

    Oral drug delivery of small chemicals, peptides (such as the GLP-a obesity drugs), and proteins is feasible by encapsulation of the guest drug into the nanoviricide polymeric micelle. The encapsulation protects the guest from metabolism thereby enabling effective drug delivery.

    Encapsulation of a difficult or failed drug within the nanoviricide polymeric micelle can enable rescue of the drug candidate turning it into a clinically viable drug candidate, saving hundreds of millions of dollars of development work.

    Going another step further, the nanoviricide platform technology can be customized to enable zip-code-like specific delivery of encapsulated drugs to specific tissues (e.g. non-liver targeted delivery),, cells (e.g. cancer-cell specific delivery sparing normal cells), bacteria, or viruses (e.g. NV-HHV-1, NV-HIV-1) in a fully synthetic chemistry based, scalable technology stack.

    ABOUT PODD 2025

    Pharma, biotech and drug delivery industries will gather at the 15th annual PODD event to assess delivery needs, explore partnership opportunities, and stay at the forefront of innovative drug delivery technologies. This includes small molecules, biologics, combination products, connected devices, cell and gene delivery and more.

    PODD provides partnering opportunities through organized networking for new, emerging and established collaborations.

    ABOUT NANOVIRICIDES

    NanoViricides, Inc. (the “Company”) ( www.nanoviricides.com ) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:

    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    SOURCE: NanoViricides, Inc.

    View the original press release on ACCESS Newswire

  • In Treating Measles Infection, NV-387 Showed Strong Antiviral Activity, and Significantly, Protected Lungs from Damage, Describes NanoViricides

    SHELTON, CONNECTICUT / ACCESS Newswire / October 22, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer:NNVC) (the “Company”), announced that its clinical lead drug NV-387 has shown strong activity against the Measles virus in cell culture studies as well as in a humanized animal model. Additionally, NV-387 treatment led to protection of lungs which is very important for keeping severely ill patients alive in late-stage viral infections. Currently, there is no approved drug for treating Measles.

    Firstly, NV-387 was found to have direct antiviral effects against Measles virus in standard cell culture-based testing that measured increase in the extent of surviving infected cells upon treatment with the drug (i.e. “CPE” or Cytopathic Effects Assay).

    Additionally, in a lethal Measles infection humanized animal model, NV-387 treatment led to a substantial increase in the number of survival days, to 17 days in NV-387-treated animals, from only 7.4 days in untreated animals, an increase of 130%, in a lethal lung infection of humanized mice by Measles virus1, as previously reported.

    The increased survival correlated with several improvements in the animal health indicating control of viral infection:

    • Slow disease progression, and mild to moderate levels of lung damage as observed in microscopic histopathology.

    • Protection of lungs was also evident from the significant reduction in the level of lung plaques (damage to lung tissue) compared to untreated cases.

    • Reduction in the level of lung-damaging lymphocytes and neutrophils attracted into the lungs (i.e. infiltration).

    These observations indicated that NV-387 treatment led to beneficial effects that protected lungs as well as reduced overall systemic infection.

    We have thus found that NV-387 has dual benefits of (i) directly reducing the virus itself, together with (ii) protecting systemic cellular damage, and in particular, protecting lungs from viral damage as well as self-inflicted damage from killer cells.

    These benefits make NV-387 an unusual and highly desirable antiviral drug.

    NV-387 has completed Phase I clinical trial in healthy subjects with no reportable adverse events, and was found to be safe and well tolerated. In IND-enabling studies, NV-387 was found to be extremely safe and well tolerated in animal models. NV-387 was found to be non-immunogenic, non-allergenic, non-mutagenic, and non-genotoxic.

    NV-387 acts by a unique mechanism of action that we call “Re-Infection Inhibition”. NV-387 is designed as a mimic of heparan-sulfate proteoglycan (HSPG) structures that are used by over 90% of human pathogenic viruses as “attachment receptor(s)”, in order to congregate close to cells before being able to bind to the virus’s direct receptors on cells (called the “cognate receptors”) and fusing into the cell. NV-387 “looks like” a cell to the virus, displaying copious amounts of the fragments that mimic HSPG on the nanoviricide micelle surface. This fools the virus into binding to the NV-387, whereupon the shape-shifting NV-387 engulfs the virus, causes lipid-lipid fusion with the virus surface, destroying its ability to infect cells.

    NV-387 is available as Oral Gummies, which dissolve slowly in the mouth; and do not require swallowing. Swallowing can be difficult for a patient in presence of a rash.

    With Measles outbreaks spreading all across the country, the USA is expected to lose the Measles elimination status, and the virus would be considered endemic thereafter as it was before 2000. Vaccination against Measles is effective, but there are limitations to its public health potential. Measles is extremely contagious, and more than 95% population needs to be vaccinated to eliminate the disease. To complicate the matters, persons with weakened or otherwise affected immune systems do not benefit from vaccination because their immune system cannot mount response to the challenge.

    Further, it has become clear in recent years that the Measles virus is drifting from the current vaccine strain (circa 1968) over the last fifty-plus years, and there is some evidence that some variants may have arisen that have greater resistance to the vaccine than in the past.

    Thus a drug for combating this emerging infectious disease of Measles is important. As a Company, we note that regulatory development of a drug specific for Measles is not cost-effective, and we will continue to seek non-dilutive grants and contracts support for further development of NV-387 as a treatment for Measles.

    NV-387 can be readily developed for Measles through FDA licensure, because it is a multi-purpose, broad-spectrum antiviral. NV-387 is being developed to treat several different viral infections acquired by the respiratory route.

    NanoViricides is working on regulatory development of NV-387 as a treatment for viral infections that include RSV, Influenza, Bird Flu H5N1, Coronaviruses, COVID-19, as well as the epidemic-threatening virus causing MPox and the bio-terrorism threat virus of Smallpox.

    ABOUT NANOVIRICIDES

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:
    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    1Humanized mice were required for the animal model because Measles virus only infects humans, and specifically uses hSLAM as the cognate receptor for cell entry, while using the ubiquitous HSPG for congregation next to cells. The mice had human hSLAM (aka hCD150) gene knocked-in, and also had their interferon responses deleted (hSLAM+k.i., IfnAR-/- transgenic mice on C57BL/6 Background). NV-387 mimics the portions on HSPG that viruses bind to, including the Measles virus, and thereby is designed to attack and engulf the virus particle via lipid-lipid mixing and destroying the virus particle’s ability to infect cells.

    SOURCE: NanoViricides, Inc.

    View the original press release on ACCESS Newswire

  • A Measles Drug with Strong Activity without Toxicity Can Be Available Now for Emergency Use, Says NanoViricides – NV-387 Broad-Spectrum Antiviral with Activity Against Measles Virus

    SHELTON, CT / ACCESS Newswire / October 20, 2025 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the “Company”), announced that its clinical lead drug NV-387 has shown strong activity against the Measles virus in a humanized animal model. The Company announces that NV-387 can now be made available for emergency use application in Measles patients to respond to the spreading Measles outbreaks.

    Having a drug to treat patients has become of paramount importance, in view of the fact that the USA is about to return to an endemic playground for the Measles virus, with over 1,600 cases as of October 17, breaking a thirty-year-plus-long record this year1.

    “We have already developed an effective drug to respond to the Measles virus outbreaks spreading all across the country,” said Anil R. Diwan, PhD, President.

    “NV-387 can be used right away for emergency use in Measles cases,” said Krishna Menon, VMD, MRCS, PhD, Consulting Scientist (Non-Clinical), adding, “With my extensive experience with non-clinical development of several marketed drugs, I can definitely say that NV-387 has excellent activity and safety in treating Measles virus infection.”

    Dr. Menon designed and conducted the humanized animal model studies for testing drugs against Measles virus infection. As such, he has hands-on experience with the effects of the drug NV-387. The data has provided compelling evidence that NV-387 is indeed highly effective in protecting the infected from the systemic effects of Measles infection.

    “The drug is manufactured under GMP in the USA,” added Jayant Tatake, PhD, Vice President of the Company.

    NV-387 has already completed Phase I clinical trial in healthy subjects with no reported adverse events.

    The Company has previously reported that in a humanized animal model of lethal Measles infection, NV-387 treatment increased survival of animals to 17 days on average compared to only 7.4 days in untreated animals, an increase of 130%. There were no signs of toxicity from the drug NV-387. Additionally, dose-dependent increase in survival was observed. In contrast, Ribavirin, an unapproved drug that may be used off-label for severe Measles cases as per CDC guidance, is known to be highly toxic.

    The Company intends to support any Physician’s Investigator Initiated New Drug Application (IIND) for emergency use of NV-387 for treatment of one or a few cases of Measles, as per FDA regulations. The Company requests physicians that would like to avail of this opportunity to contact us.

    NV-387 is a revolutionary novel drug that defines a new mechanism of action, in that it attacks the virus particles and destroys them.

    NV-387 is available as Oral Gummies, which dissolve slowly in the mouth; and do not require swallowing. Swallowing can be difficult for a patient in presence of a rash.

    With Measles outbreaks spreading all across the country, the USA is expected to lose the Measles elimination status, and the virus would be considered endemic thereafter as it was before 2000. However, Measles is extremely contagious, and more than 95% population needs to be vaccinated to eliminate the disease. To complicate the matters, persons with weakened or otherwise affected immune systems do not benefit from vaccination because their immune system cannot mount response to the challenge.

    Further, it has become clear in recent years that the Measles virus is drifting from the current vaccine strain (circa 1968) over the last fifty years, and there is evidence that some variants may have arisen that have greater resistance to the vaccine than in the past.

    Thus a drug for combating this emerging infectious disease is important. Regulatory development of a drug specific for Measles is not cost-effective.

    NV-387 can be readily developed for Measles through FDA licensure, because it is a multi-purpose, broad-spectrum antiviral. NV-387 is being developed to treat several different viral infections acquired by the respiratory route. The Company is working on regulatory development of NV-387 as a treatment for viral infections that include RSV, Influenza, Bird Flu H5N1, Coronaviruses, COVID-19, the epidemic-threat MPox and the bio-terrorism threat, Smallpox.

    1https://www.cdc.gov/measles/data-research/index.html. October 14 – 1,596 confirmed cases.
    https://www.yahoo.com/news/articles/south-carolina-sees-surge-measles-181413555.html . October 17 – case count increased from 15 to 19.

    ABOUT NANOVIRICIDES

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:
    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    SOURCE: NanoViricides, Inc.

    View the original press release on ACCESS Newswire

  • NanoViricides Dual Track Clinical Strategy Explained by a Research Report – Broad-spectrum Antiviral NV-387 At Phase II Clinical Trial Stage for MPox and also for Acute Respiratory Infections of All Viruses

    SHELTON, CONNECTICUT / ACCESS Newswire / October 15, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), reports that an analyst research report was published on the Company that explains its dual-track, rapid clinical development strategy for NV-387, going after MPox and also after all respiratory viral infections, that include Influenzas, Coronaviruses, RSV among others. The analyst research report was published by proactive investors news (https://www.proactiveinvestors.com/companies/news/1080303/nanoviricides-dual-track-clinical-development-during-2026-1080303.html/long).

    The analyst research report summarizes:

    “Nanoviricides (NNVC), a US company, targets the unmet medical need for an effective, broad- spectrum acute oral antiviral therapy with NV-387. NNVC’s nano-polymer, micelle technology directly binds and destroys virus particles in the blood preventing them entering and infecting cells; in effect a highly selective, ruthless (but safe) nanomachine.

    NNVC is now pursuing a dual track strategy for clinical development. The first trial will be against MPox virus, a relative of smallpox. The second is in respiratory viral diseases. NV’s lead molecule NV-387 has already completed a Phase 1 study in 2023 showing safety and tolerability.

    The immediate study, which could start by late CY25 or early in CY26, is for MPox. MPox is an endemic virus related to smallpox so has biodefense applications. Ethics approval for an NV- 387 Phase 2 trial in Congo has already been gained; the next stage is a formal Phase 2 Clinical Trial Application (CTA). A successful African trial could lead to possible development funding from the US biodefense agency (BARDA).

    The second planned study uses mostly the same CTA as the MPox study but will target respiratory viral diseases. An adaptive “basket-type” trial in India will gather data on NV-387 efficacy against flu, RSV and coronaviruses. This might start in winter 2026 but a later start is possible. This could lead to focused US trials, perhaps from 2027. Management notes independent estimates of a US$2.6 bln opportunity in RSV and US$4.6 bln in influenza.”

    Additional details can be found in the analyst research report.

    About NanoViricides

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:
    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    SOURCE: NanoViricides, Inc.

    View the original press release on ACCESS Newswire

  • NanoViricides, Inc. Has Filed its Annual Report

    Broad-spectrum Antiviral NV-387 At Phase II Clinical Trial Stage – NV-387 Could Become a Revolutionary Antiviral for Respiratory Viral Infections

    SHELTON, CONNECTICUT / ACCESS Newswire / September 30, 2025 / 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, 2025 with the Securities and Exchange Commission (SEC) on Monday, September 29, 2025. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000110465925094527/nnvc-20250630x10k.htm).

    In the fiscal year 2025, we have achieved a substantial level of accomplishments. We have focused on evaluating the broad spectrum of antiviral activity of NV- 387.

    We believe that NV-387 is on its way to become a revolutionary antiviral therapy that could be prescribed for practically any respiratory viral infection without first testing for the causative virus, just as broad-spectrum antibiotics can be prescribed even before testing for the causative bacteria. This “emperic therapy” approach would enable immediate treatment and thus improve effectiveness; it is well known that antiviral treatments are most effective when given early.

    NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for such emperic therapy of viral ARI/SARI.

    To this end, we have proposed a novel adaptive, Phase II clinical trial for the evaluation of NV-387 as a treatment for Viral Acute/Severe Acute Respiratory Infections (V-ARI, V-SARI) towards this goal. A preliminary clinical protocol for this complex trial has been developed.

    At present, we are fully engaged in completing the Clinical Trial Application (CTA) for a Phase II clinical trial of NV-387 for the treatment of MPox disease in Africa. MPox continues to spread and surge in African countries and is endemic in the Democratic Republic of Congo (DRC) and neighboring countries. Due to this, African CDC has continued its declaration of Public Health Emergency of Continental Security (PHECS), initiated in August 2024, as of September, 2025. We have already obtained a preliminary approval for our clinical trial protocol for this clinical trial from the regulatory agency in charge, namely ACOREP in DRC.

    We plan on leveraging the MPox studies towards approval of NV-387 as a treatment of Smallpox under the US FDA “Animal Rule”. The US agency BARDA has programs to support such development if NV-387 qualifies.

    A potential acquisition of NV-387 for Smallpox under the US Strategic National Stockpile (US-SNS) if approved could be worth of the order of $1 billion over five years. We believe (i) NV-387 for treatment of MPox, (ii) NV-387 for the treatment of Smallpox, and (iii) NV-387 for the treatment of Measles, would be separately eligible for Orphan Drug Designation (ODD) by the US FDA. An ODD carries several benefits. Certain FDA fees would be waived. Up to seven years of market exclusivity would become available. There are also research and development tax benefits. In addition, some of these programs may be eligible for issuance of a tradable “Priority Review Voucher” (PRV) upon drug approval. A PRV if issued to us would in itself be a revenue generator with a value of over $150 million.

    Smallpox is a bioterrorism threat. Two drugs, namely, tecovirimat and brincidofovir were approved in the USA for Smallpox under the FDA “Animal Rule” and have been acquired in the US-SNS. Both of these drugs have limitations. Therefore, the US agency BARDA is searching for a new drug. We believe NV-387 matches their requirements.

    MPox Clade II is endemic in the USA and some European countries. MPox Clade Ia and Ib are more severe strains than Clade IIa or IIb, and are spreading in Africa. Clade Ia/Ib strains could break out of Africa globally and thereby cause severe pandemics. MPox is a much less severe cousin of Smallpox when compared in terms of the pathogenic effects and case fatality rates of the virus.

    There is no drug for treatment of MPox at present. Tecovirimat failed in clinical trials for the treatment of MPox [1], [2]. Brincidofovir entered clinical trials for MPox in January, 2025, and interim results were anticipated in Q1 2025, according to the press release by Africa CDC [3]. The current status of this brincidofovir for MPox clinical trial is not publicly known [4] . Brincidofovir carries a black box warning due to increased mortality rates in another indication, causes elevation of liver damage-related markers, is a carcinogen, may cause embryonic or fetal harm, and may irreversibly impair fertility, according to its prescribing information [5], limiting its applicability.

    Thus we believe NV-387 has a wide opportunity as a treatment of MPox, which can be currently estimated to be a market size approaching $1 Billion in African region alone.

    We reported that, as of June 30, 2025, we had cash and cash equivalent current assets balance of approximately $1.67 Million. In addition, we reported approximately $6.83 Million in Net Property and Equipment (P&E) assets (after depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT, where we manufacture our clinical trial drug substance and drug products, thus producing substantial savings as compared to working with an external manufacturer (CDMO). The total current liabilities were approximately $1.31 Million. In comparison, as of June 30, 2024, we had cash and cash equivalent balance of approximately $4.97 Million, P&E assets of approximately $7.5 Million (after depreciation), and total current liabilities of approximately $1.36 Million.

    The net cash utilized in the reported period for operating activities was approximately $8.48 million, which includes continuing expenditures for completion of the Phase Ia/Ib clinical trial of NV-387 in India, and R&D and preparatory work including cGMP manufacture of the drug substance for the Phase II clinical trial of NV-387 for treatment of MPox in Africa.

    We raised approximately $5.3 million in net cash from financing activities, which comprised of an “At-the-Market” offering in an ATM Agreement with D. Boral Capital.

    Subsequent to the reported period, we have raised approximately $1 million additional under the said ATM. Further, our founder, Dr. Anil Diwan has provided a line of credit (LOC) of $3 million to the Company. We have not yet drawn on the LOC. As such, we reported that we do not have sufficient funding in hand as of now to continue operations through September 30, 2026, for our planned objectives. As a result substantial doubt exists about the Company’s ability to continue as a going concern, as evaluated based on applicable guidelines. We are actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to our plan. We believe that the Company has on-going access to the capital markets including the “At-The-Market” (ATM) agreement that became active around April 5, 2024. We have previously adjusted our objectives and development plans on the basis of available resources and we will continue to do so.

    This year, we have re-calibrated our priorities to seek opportunities with early fruition and lower cost compared to going after the longer horizon opportunities such as pediatric RSV treatment. We note that the Phase II clinical trial evaluating NV-387 for V-ARI/V-SARI will provide us with required information to move further into a Phase III for pediatric RSV approval.

    We have several important milestones in the new year:

    Completion and submission of the Phase I Clinical Study Report to the Indian regulatory Agency.

    Filing of the Phase II Clinical Trial Application for the evaluation of NV-387 as a treatment for MPox to ACOREP in DRC, its Approval by the regulator, Commissioning of the clinical trial, and Interim Results.

    Filing of Orphan Drug Designation applications to the US FDA as cited above, and their anticipated approval.

    Filing of a pre-IND with the US FDA towards NV-387 for Smallpox treatment under the “Animal Rule”.

    Filing of an IND with the US FDA towards evaluation of NV-387 as a Smallpox treatment leading to registration.

    Filing of the Phase II Clinical Trial Application for the evaluation of NV-387 as a treatment for Viral Respiratory Infections in India, its Approval by the regulator, and Commissioning of the clinical trial, and Interim Results.

    As we meet the milestones, we believe we will be able to raise financing for further regulatory activities for NV-387 registration via non-dilutive grant funding, partnership revenues, as well as equity-based funding.

    We believe the Company has a bright future. Our Phase II clinical stage drug NV-387 has completed Phase I clinical trial with the successful results that there were no drop-outs, and there were no reported adverse events, both of which clearly indicate excellent safety and tolerability in humans. NV-387, as mentioned above, is likely to become a revolutionary broad-spectrum antiviral therapeutic, that could change how we treat viral infections forever. In addition, the Company has developed a pan-Herpesvirus drug, NV-HHV-1. Its skin cream formulation for the treatment of Shingles rash, Chickenpox, HSV-1 Cold Sores, and HSV-2 Genital Ulcers, has completed certain IND-enabling non-clinical studies. NV-HHV-1 has demonstrated effectiveness in a human skin model of VZV infection (Varicella-Zoster-Virus, which causes Chickenpox and Shingles). A systemic form of the herpesvirus drug is in development. The Company has also developed an anti-HIV drug, NV-HHV-1, which the HIV viruses would not be able to escape despite rapid virus evolution. NV-HHV-1 has demonstrated strong effectiveness superior to triple-drug combination HAART therapy in a humanized animal model of HIV infection.

    The Company’s technology is based on mimicking the host-side binding sites that the virus uses which remain the same despite several and extensive changes in the virus. We design and make chemical mimics of these sites to create virus-binding ligands that we attach to a base polymer. This makes the drug look like a cell membrane to the virus. The nanoviricide drug is thus designed to fool the virus into entering the nanoviricide drug micelle and uncoating itself by using the virus’s own smarts against it.

    We believe viruses would not be able to escape nanoviricide drugs because of this design. In contrast, viruses readily escape vaccines, antibodies, and most of the small chemical drugs.

    Oral NV-387 was found to be superior to the three known drugs oseltamivir (Tamiflu®, Roche), peramivir (injection, Rapivab®, BioCryst), as well as baloxavir (Xofluza®, Shionogi/Roche) in a lethal lung infection animal model of Influenza.

    Oral NV-387 was found to cure lethal lung RSV infection in an animal model. There is no current approved drug for treating RSV infection.

    Previously, NV-387 given both orally and as I.V. injections was found to be substantially superior to remdesivir (injection, Gilead) in a lethal lung infection animal model for COVID-19.

    Oral NV-387 was found to be equivalent to or superior than tecovirimat (TPOXX®, SIGA) in two different lethal animal models of orthopoxvirus diseases. One of these models simulated skin infection which is the primary route of MPox Clade II infections. Another animal model simulated direct lung infection which is the likely route of Smallpox infection in case of bioterrorism.

    About NanoViricides

    NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

    The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.

    Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

    NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. 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 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, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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.

    The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

    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. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

    Contact:
    NanoViricides, Inc.
    info@nanoviricides.com

    Public Relations Contact:
    ir@nanoviricides.com

    View the original press release on ACCESS Newswire