The Fort Worth Press - While Measles Cases Continue to Increase in The USA and Globally, NanoViricides is Getting Ready for Clinical Trials of Its Revolutionary Broad-spectrum Drug Candidate NV-387 as A Treatment for Measles

While CDC is reviewing the two recent measles-related fatalities in Pennsylvania, the total number of confirmed measles cases in the USA has reached 2,903 as of August 27, 2026, in comparison to 2,289 confirmed cases in the whole year of 2025, indicating continuing expansion of measles¹. Cases of Measles have been rising globally for different reasons. The measles outbreak in Bangladesh has continued to proliferate, claiming 19,218 confirmed cases with 99 fatalities in confirmed cases from 15 March to 30 August, 2026. During this period, a total of 1,37,347 patients with suspected measles were admitted to hospitals and 868 children have died of suspected measles, whereas 1,151 suspected measles cases with 4 deaths were reported in just the last 24 hours in Bangladesh². The measles outbreak in Bangladesh has continued despite aggressive vaccination campaign that was undertaken since April-May 2026.

In the USA, since COVID-19 days, the MMR vaccination rate has fallen from 95.2% in 2019-2020 to an average of 92.4% in 2025-26, which can be clearly ascribed to the general public vaccine hesitancy that has resulted from the aggressive COVID vaccination policies. The current MMR vaccination rate is well below the 95% putative threshold that is generally agreed as necessary to block spread of measles, with approximately 280,000 unvaccinated kindergartners at risk of measles, according to CDC (ibid #1). The rate of "breakthrough" measles cases in the USA has remained steady at about 6% (~3% in single dose and ~3% in full 2-dose vaccinated individuals) (CDC data).

There is currently no approved drug for measles. Vaccine does not help a patient already infected with the measles virus. Vaccinating already measles-exposed persons to avoid disease spread is attempted yet measles has continued to spread in the USA.

Thus an effective treatment for Measles is an unmet medical need. NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study.

NanoViricides is currently developing a Phase II clinical trial protocol for evaluating NV-387 as a treatment for measles. A draft is being circulated. The Company intends to bring this protocol under the purview of the US FDA in an IND process. Therefore, this work is expected to take some time.

NV-387 has been granted a "Rare Pediatric Disease Drug" (RPDD) Designation by the US FDA Office of Orphan Products Development (OOPD).

This RPDD designation enables that a Priority Review Voucher (PRV) can be issued to the Company upon a successful Marketing Application (i.e. New Drug Application) for the use of NV-387 as a treatment for Measles, provided all of the required conditions are met.

The Company can use the PRV, if granted, to reduce review times on another of its drug applications. Importantly, a PRV can be sold to another Pharma Company for accelerating their drug program as well, which provides a high value to the purchaser. Recently, a PRV has been sold for $195 Million³.

Sale of a PRV can bring cash to the Company even prior to revenues from commercialization of a drug product.

"The Rare Pediatric Disease Drug Designation and associated Priority Review Voucher that can be issued make a strong business case for development of NV-387 as a drug for the treatment of Measles," said Anil R. Diwan, PhD., adding, "NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved."

FDA has granted both ODD and RPDD for NV-387 as a Treatment of Measles.

In addition to the PRV eligibility provided by the RPDD for NV-387 as a treatment of Measles, the Orphan Drug Designation qualifies NanoViricides for incentives including:

• Tax credits for qualified clinical trials;

• Exemption from certain user fees;

• Potential seven years of market exclusivity after approval;

according to the US FDA⁴.

Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases. Measles primarily affects children. These facts have qualified NV-387 for Measles Treatment for an Orphan Drug Designation, and also for a Rare Pediatric Disease Drug Designation. In a rare disease scenario, commercial revenue from the drug may be slow and small. The PRV is designed to incentivize drug development for rare pediatric diseases by providing additional business value.

Measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks.

Measles is endemic globally; many countries that had achieved an elimination status for Measles have by now lost this status, due to severe outbreaks over the last three years⁵.

Measles is a highly contagious disease, and spreads via virus particles in bodily fluids upon close contact. A population vaccination rate of at least 95% is required to provide "herd immunity" and block community spread. Such a high rate is difficult to maintain for several reasons. Firstly, vaccine hesitancy is rising globally. Secondly, persons with co-morbidities such as immune-compromise status, diabetes, obesity, etc. do not respond fully to any vaccination. Even if vaccinated, such a person can still get Measles, suffering from possibly a mild disease, but will still be contagious and spread Measles. Additionally, the Measles virus continues to change, with the B and D genotypes in circulation currently, while the vaccines in use are still the ones developed for the A genotype in the 1960's.

Further, very high rates of infections in vaccinated subjects (called "breakthrough cases"), from 14% to 57%, have occurred in some outbreaks⁶ suggesting that resistant virus strains may have been involved.

Therefore, an effective treatment for Measles is an unmet medical need, that is expected to become even more important in the near future than it is today. Only an effective treatment can help the patient and can avoid the potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities as well as immune amnesia that can result from severe disease.

Quicker recovery of a patient means less chances for spread and thus better ability to control an outbreak. This would require an effective treatment.

NV-387 is an extremely 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.

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.
[email protected]

Public Relations Contact:
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View the original press release on ACCESS Newswire

H.Carroll--TFWP