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:

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.