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SHELTON, CONNECTICUT / ACCESS Newswire / December 1, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has signed a Master Services Agreement (MSA) with Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote. Dr. Cote and OOC will help the Company formulate its orphan drug strategy for NV-387, as well as develop relevant orphan drug designation applications and prosecute these applications at the US FDA Office of Orphan Products.
"In earlier discussions with Dr. Cote, it became apparent that the broad-spectrum antiviral drug NV-387 could harness several benefits from an orphan drug regulatory strategy," said Anil R. Diwan, PhD, President & Executive Chairman of the Company.
NV-387 has demonstrated excellent activity against lethal animal models of orthopoxvirus ectromelia infections in mice. This opens up the regulatory pathway for licensure of NV-387 for the treatment of Smallpox. NV-387 for the treatment of Smallpox is expected to be eligible for an "Orphan drug" designation by the US FDA. Smallpox, eradicated globally in 1980, is considered an important bioterrorism threat.
Additionally, MPox disease caused by the Monkeypox virus, MPXV, a related orthopoxvirus, is considered an "orphan disease" in the USA. Therefore, we believe that NV-387 for the treatment for MPox will be eligible for orphan drug designation.
Further, NV-387 is the only drug candidate to our knowledge that has demonstrated in vivo activity against the Measles virus in a humanized animal model study. Measles infection in the USA is considered an "orphan disease" due to the small number of cases. Therefore, we believe that NV-387 for the treatment for Measles will be eligible for orphan drug designation.
Orphan drug designation qualifies sponsors for incentives including:
Tax credits for qualified clinical trials;
Exemption from user fees;
Potential seven years of market exclusivity after approval;
according to the US FDA (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products).
Measles cases are rising across the Western world. The USA is likely to lose its Measles elimination status in 2026, if the current outbreak that began in Texas in January 2025 continues through the whole year. Canada has already lost its Measles elimination status. This means Measles is now considered endemic in Canada, and will likely be considered to be endemic in the USA as well. As of November 25, 2025, a total of 1,798 confirmed measles cases were reported in the United States, in 46 outbreaks, across 42 states, according to the CDC (https://www.cdc.gov/measles/data-research/index.html).
NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.
Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors.
Viruses crossing over newly into humans from other species do so only upon acquiring significant ability to bind to HSPG, the cell-side molecule that NV-387 mimics as a decoy for the viruses [1] . It is highly unlikely that bioterrorism agents would be created that can drastically infect humans and yet do not bind to HSPG.
To date, pandemic preparedness has been dominated by one-drug-one-bug philosophy. With hundreds of potential biothreats, such a strategy is too expensive and would not realize a highly effective protective shield against potential pandemics.
Besides, the medical countermeasures pursued to-date for pandemic preparedness are severely lacking in that every one of them would be readily defeated by the virus as it mutates or evolves in the field. This is one lesson that has become starkly clear after the COVID-19 pandemic.
NV-387 is expected to provide a low cost option for pandemic preparedness against a multiplicity of threats, and could become an effective first response drug for practically any viral pandemic. Over 90% of viruses that can cause disease in humans are known to bind to HSPG. Our development of NV-387 suggests that most of these viruses would be susceptible to NV-387. Moreover, escape from NV-387 is highly unlikely because even as viruses mutate or evolve, they continue to bind well to HSPG as long as they are pathogenic in humans.
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.co
[1] It has been reported that highly pathogenic duck influenza viruses that lack or substantially lack HSPG binding ability do not cause significant pathology in other birds, nor in humans. They appear to use exclusively sialic acid-related receptors and yet have failed to infect other species. We believe these results require further investigation.
SOURCE: NanoViricides
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