Star Metro - An Investigational Drug to Tackle Measles Outbreaks

There have been three deaths in children due to Measles in the USA in the last ten days, one each in the states of New York, Pennsylvania, and Wisconsin ⁱ.

This condition should be unacceptable in the USA because there is already a drug against Measles that has shown effectiveness in a humanized animal model of Measles, that has gone through extensive studies including Phase I human safety study, and that is already in two Phase II clinical trials for other viral infections.

This investigational drug is NV-387, a novel, revolutionary broad-spectrum, antiviral drug developed by the Company. This drug has completed a juvenile animal model study as well. NV-387 is not yet FDA-approved or commercially available for treating Measles or any other viral disease. However, we believe the drug NV-387 now has sufficient data available to enable use under the US FDA physician-initiated investigational new drug application mechanism that is designed for use of experimental drugs for specific severe cases of disease, such as Measles. The Company continues to develop this drug in the regulatory pathways.

There were 5,164 confirmed Measles cases within the USA (excluding international visitors) as of November 5, 2026, reported in 47 jurisdictions, with 4% of these being breakthrough cases in vaccinated individuals, and remaining 96% in unvaccinated individuals. 562 (11%) of the cases were hospitalized, and 4 confirmed Measles-caused deaths were recorded. A few additional deaths in Measles cases that are under CDC review have also occurred. Majority of hospitalizations occurred in children under 5 years of age. Only 4 states, namely Arkansas, Hawaii, Mississippi, and Nevada have not reported a Measles case in 2026, according to the CDC ⁱⁱ. These data indicate that Measles in the USA is continuing to expand in 2026.

At this point, loss of the Measles elimination status achieved by the USA in 2000 as the very first country to achieve this status would be merely symbolic, emphasizing that Measles is a globally endemic virus with a very high potential for creating a contagion.

Vaccines, even though effective, are inadequate as the only response to such a disease as Measles, and drugs to treat Measles infections are sorely needed.

Of note, the D8 genotype of the Measles virus dominates in 2026 US cases ⁱⁱⁱ whereas the Measles vaccine is based on the A genotype.

NV-387, the Company's revolutionary clinical stage broad-spectrum antiviral drug is currently in a Phase II clinical trials as an oral treatment for the Ebola Bundibugyo virus epidemic in the Democratic Republic of Congo (DRC).

The same drug, NV-387, formulated as the same oral gummies formulation is also in a Phase II clinical trial for the treatment of Mpox (Monkeypox) in DRC in a different province.

This very same drug has demonstrated remarkable antiviral activity against the Measles virus in a humanized hCD150+, IfnAR-/- mouse model of Measles virus infection and disease.

The Company has also completed a repeat-dose juvenile mouse model toxicity study in which 4-day old mouse pups were dosed with repeated doses of NV-387 oral gummies formulation to evaluate the safety and tolerability of the drug and drug product in the context of the use of the drug in children.

Under the conditions of this Juvenile Mouse Model study, the No Observed Adverse Effect Level (NOAEL) was determined to be 1,230 mg/kg per dose administered three times daily, or 3,690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. This was actually the highest dose level tested. Therefore, a Maximum Tolerable Dose (MTD) could not be estimated ^iv.

Further, there was no mortality, systemic toxicity, treatment-related clinical observations, adverse effects on body weight gain, alterations in cardiovascular parameters, changes in clinical pathology, or treatment-related gross or microscopic pathological findings observed in either sex.

According to established guidelines for juvenile animal model data extrapolation, a drug evaluated for safety toxicology in 4 day mouse pups supports clinical pediatric study in infants as young as 1 month ^v, under an appropriate regulatory study.

Cases of Measles have been rising globally for different reasons. The measles outbreak in Bangladesh has continued to proliferate, claiming 24,073 lab-confirmed cases with 105 fatalities in lab-confirmed cases from 15 March to 10 November, 2026. During this period, a total of 207,428 patients with suspected measles were hospitalized and 1,263 persons, mostly children, have died of suspected measles, while 1,318 new suspected measles cases with at least 6 more child deaths were reported in just the last 24 hours in Bangladesh ^vi. The measles outbreak in Bangladesh has continued despite aggressive vaccination campaign that was undertaken since April-May 2026.

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, supporting its clinical regulatory development for treatment of Measles.

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.

A PRV can be sold to another Pharma Company for accelerating their drug program as well, which provides a high value to the purchaser. PRVs have been sold for as much as $200 Million ^vii.

"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 FDA^viii.

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 years ^ix.

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 outbreaks^x 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:
Attn: Media Contact
NanoViricides, Inc.
1 Controls Drive, Shelton, CT 06484.
Tel: +1 (203) 937-6137.
[email protected]

Public Relations Contact:
[email protected]

Source: NanoViricides, Inc. Primary Account.

i https://www.contagionlive.com/view/measles-update-november-6-2026 .

ii https://www.cdc.gov/measles/data-research/index.html

iii GenomicEpi Measles Surveillance Report · 2026, created November 7, 2026.

iv NOAEL is the highest amount of drug exposure at which there are no significant increases in adverse effects compared to a control group. MTD is the highest amount of drug exposure that does not cause unacceptable side effects or overt toxicity.

v Barrow, PC, and Schmitt, G. "Juvenile Nonclinical Safety Studies in Support of Pediatric Drug Development," Methods Mol Biol. 2017:1641:25-67. doi: 10.1007/978-1-4939-7172-5_2.

vi https://www.tbsnews.net/bangladesh/health/measles-death-toll-reaches-1263-6-more-children-die-1591441

vii https://prvwatch.com/

viii https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

ix https://www.cfr.org/articles/many-countries-eliminated-measles-why-is-it-coming-back-in-the-u-s-and-globally

x Fappani,et al. Breakthrough Infections: A Challenge towards Measles Elimination?. Microorganisms 2022, 10, 1567. https://doi.org/10.3390/microorganisms10081567

SOURCE: NanoViricides

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